JOM - April 2021

journal of
osteopathic
medicine

AOA EDITOR IN CHIEF NEUROMUSCULOSKELETAL MEDICINE/OMT
Ross D. Zafonte, DO Section Editor: Michael A. Seffinger, DO
Spaulding Rehabilitation Hospital Harvard Medical School Western University of Health Sciences College of Osteopathic Medicine
Boston, Massachusetts of the Pacific
Pomona, California
EDITORIAL BOARD
Associate Editor:
BEHAVIORAL HEALTH Sheldon C. Yao, DO (Old Westbury, New York)
Section Editor: Eileen Ryan, DO
The Ohio State University Wexner Medical Center OBSTETRICS AND GYNECOLOGY
Columbus, Ohio Section Editor: Meaghan Nelsen, DO
The University of North Texas Health Science Center
Associate Editors: Fort Worth, Texas
Justin Faden, DO (Philadelphia, Pennsylvania)
R. Gregory Lande, DO (Silver Spring, Maryland) Associate Editors:
Jed Magen, DO, MS (East Lansing, Michigan) Kiran Kavipurapu, DO, JD, MPH (San Francisco, California)
Stephen M. Scheinthal, DO, CS (Mount Laurel, New Jersey) Daniel J.S. Martingano, DO, PhD (Rockaway, New York)
DeEtte Vasques, DO (Fort Worth, Texas)
CARDIOPULMONARY MEDICINE
Section Editor: Kenneth J. Steier, DO, MBA, MPH PEDIATRICS
Touro College of Osteopathic Medicine Section Editor: Amanda Foster, DO
Middletown, New York Oklahoma State University
Tulsa, Oklahoma
Associate Editors:
Olalekan Ogunsakin, MD, PhD, MBA, MPH (New York, New York) Associate Editors:
Tanchun Wang, PhD (Middletown, New York) Michael A. Baxter, DO (Tulsa, Oklahoma)
Alissa Craft, DO, MBA (Scottsdale, Arizona)
MEDICAL EDUCATION Colony S. Fugate, DO (Tulsa, Oklahoma)
Section Editor: Nadege Dady, EdD Tami Hendriksz, DO (Vallejo, California)
Touro College of Osteopathic Medicine Muhammad Waseem, MD, MS, CHSE-A (Bronx, New York)
New York, New York
PRIMARY CARE AND PUBLIC HEALTH
Associate Editor: Section Editor: Elizabeth A. Beverly, PhD
Albert H. O-Yurvati, DO, PhD (Fort Worth, Texas) Ohio University Heritage College of Osteopathic Medicine
Athens, Ohio
MUSCULOSKELETAL MEDICINE AND PAIN Section Editor: Kevin M. Pantalone, DO, ECNU
Section Editor: Arthur J. De Luigi, DO Cleveland Clinic
Mayo Clinic Twinsburg, Ohio
Phoenix, Arizona
Associate Editors:
Associate Editors: John Ashurst, DO, MSc (Scottsdale, Arizona)
Mary E. Caldwell, DO (Henrico, Virginia) Craig S. Boisvert, DO (Lewisburg, West Virginia)
Jonathan W. Lowery, PhD (Indianapolis, Indiana) John J. Dougherty, DO (Provo, UT)
R. Dallin Thomas, DO, MPH, CAQSM (Bethesda, Maryland) Lisa M. Hodge, PhD (Fort Worth, Texas)
Kim Pfotenhauer, DO (Vallejo, California)

CME EDITOR
Alissa Craft, DO, MBA (Scottsdale, Arizona)

INTERNATIONAL ADVISORY BOARD
Yasir Rehman, MD, MsC, PhD (Ontario, Canada)
Cleofás Rodríguez Blanco, PhD, DO (Madrid, Spain)
Loic Treffel, DO, PhD (Toulouse, France)

STUDENT, RESIDENT, AND FELLOW
ADVISORY BOARD
Emily Chin, OMS IV, MBA, MHA (Auburn, Alabama)
Divakara Gouda, OMS I (Stratford, New Jersey)
Matthew Mayeda, OMS IV, MPH (East Lansing, Michigan)
Jason Vadhan, OMS III (Fort Lauderdale, Florida)

REPRESENTATIVE FROM THE AOA BOARD
OF TRUSTEES
Emily K. Hurst, DO (White Lake, Michigan)

AOA LEADERSHIP
President:
Thomas L. Ely, DO

President-elect:
Joseph A. Giaimo, DO

Chief Executive Officer:
Kevin M. Klauer, DO, EJD

EDITORS IN CHIEF EMERITUS
Robert Orenstein, DO
Mayo Clinic
Phoenix, Arizona

Thomas Wesley Allen, DO, MPH
Oklahoma State University Center for Health Sciences College of
Osteopathic Medicine
Tulsa, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma

Gilbert E. D'Alonzo Jr, DO
Temple University School of Medicine
Philadelphia, Pennsylvania

EDITORIAL STAFF
Senior Vice President, Communications and Marketing:
Lori Wemhoff, MA

Director:
Melissa Schmidt, MEd

Senior Publishing Editor:
Hunter Alexander

ABSTRACTED/INDEXED IN The Journal of Osteopathic Medicine is indexed by the National Library of Medicine

e-ISSN 2702-3648

EDITORIAL OFFICE Melissa B. Schmidt, MEd, American Osteopathic Association, 142 E. Ontario St., Chicago, IL 60611-2864,
Email: [email protected]

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J Osteopath Med 2021 | Volume 121 | Issue 4

Contents

Editorial Medical Education

Elizabeth A. Beverly, PhD 333 Original Articles
Building an osteopathic research culture
Michael A. Downing, BS, Michael O. Bazzi, BS, Mark E.
Behavioral Health Vinicky, MS, Nicholas V. Lampasona, BS, Oleg Tsvyetayev,
BS and Harvey N. Mayrovitz, PhD
Original Article Dietary views and habits of students in health
professional vs. non-health professional graduate
Adam W. Hanley, PhD, Eric L. Garland, PhD and Rebecca programs in a single university 377
Wilson Zingg, DO
Mindfulness-based waiting room intervention for Tyler Hamby, PhD, W. Paul Bowman, MD, Don P. Wilson,
osteopathic manipulation patients: a pilot randomized MD and Riyaz Basha, PhD
controlled trial 337 Mentors’ experiences in an osteopathic medical student
research program 385

Cardiopulmonary Medicine Musculoskeletal Medicine and Pain

Original Article Original Article

Ariana S. Dalgleish, OMS II, Adrienne M. Kania, DO, Harald Musa S. Danazumi, PT, MSc, Bashir Bello, PT, PhD,
M. Stauss, MD, PhD and Adrianna Z. Jelen, OMS II Abdulsalam M. Yakasai, PT, PhD and Bashir Kaka, PT, PhD
Occipitoatlantal decompression and noninvasive vagus Two manual therapy techniques for management of
nerve stimulation slow conduction velocity through the lumbar radiculopathy: a randomized clinical trial 391
atrioventricular node in healthy participants 349

General Neuromusculoskeletal Medicine (OMT)

Review Article Brief Report

Mary Beth Babos, PharmD, Joseph D. Perry, BS, Sara A. Adrienne M. Kania, DO, Kailee N. Weiler, OMS III, Angeline
Reed, BS, Sandra Bugariu, BS, Skyler Hill-Norby, BA, Mary P. Kurian, OMS III, Marielle L. Opena, DO, Jennifer N.
Jewell Allen, DO, Tara K. Corwell, BS, Jade E. Funck, MS, Orellana, OMS III and Harald M. Stauss, MD, PhD
Kaiser F. Kabir, MS, Katherine A. Sullivan, MS, Amber L. Activation of the cholinergic antiinflammatory reflex by
Watson, BS and K. Kelli Wethington, BSN occipitoatlantal decompression and transcutaneous
Animal-derived medications: cultural considerations and auricular vagus nerve stimulation 401
available alternatives 361
Neuromusculoskeletal Medicine (OMT)
Medical Education
Review Article
Brief Report
Yasir Rehman, MD, MSc, PhD (C), Hannah Ferguson,
Jared Dubey, DO, Sarah James, DO and M.OMSc, BSc, Adelina Bozek, MD, Joshua Blair, M.OMSc,
Larissa Zakletskaia, MA BSc, Ashley Allison, BA and Robert Johnston, M.OMSc
Osteopathic manipulative treatment for allopathic Dropout associated with osteopathic manual treatment
physicians: piloting a longitudinal curriculum 371 for chronic noncancerous pain in randomized controlled
trials 417

J Osteopath Med 2021 | Volume 121 | Issue 4

Public Health and Primary Care Letters to the Editor

Commentary David Hohenschurz-Schmidt, MSc, MOst, Jan Vollert, Dr sc
hum MSc, Steven Vogel, DO, Andrew S.C. Rice, MD, PhD
Kenneth H. Johnson, DO 429 and Jerry Draper-Rodi, D.Prof.(Ost) DO
Joining forces to administer COVID-19 vaccines Performing and interpreting randomized clinical
trials 443
Public Health and Primary Care
Marco Tramontano, DO, Christian Lunghi, DO, Simone
Review Article Pagnotta, DO, Camilla Manzo, DO, Francesca Manzo, DO,
Stefano Consolo, MSc and Vincenzo Manzo, MD, DO
Antonia M. Molinari, OMS III and Jay H. Shubrook, DO Response to a letter to editor from Hohenschurz-Schmidt
Treatment options and current guidelines of care for pediatric et al 447
type 2 diabetes patients: a narrative review 431

Clinical Image Jason D. Vadhan, OMS IV, Lauren J. Crispino, OMS IV and
James B. Carmody, MD
Oluwadamilola A. Adeyemi, MD and Craig A. Backous, DO Teleclerkships? The role of telemedicine in medical
Giant cell arteritis of the uterus 441 student education during COVID-19 and beyond 449

J Osteopath Med 2021; 121(4): 333–335

Editorial

Elizabeth A. Beverly*, PhD

Building an osteopathic research culture

https://doi.org/10.1515/jom-2021-0055 in research during medical school [7–9]. However,
COMs may struggle to meet the growing demands of
Despite a tumultuous year in 2020, the osteopathic medical osteopathic medical students’ research needs in under-
community achieved notable milestones. For the first time, graduate medical education, including experienced and
the number of doctors of osteopathic medicine (DOs) and available mentors.
osteopathic medical students totaled more than 150,000 in
the United States (US) [1]. Of those, more than 31,000 stu- Historically, the osteopathic profession has not
dents trained at 38 colleges of osteopathic medicine (COM), prioritized a culture of research [10–12]. The inattention
representing one in every four US medical students [1, 2]. toward research is evidenced in a lack of federal funding
Calendar year 2020 also marked the culmination of the at COMs and criticism from graduating seniors. A recent
five year transition to a single graduate medical education review of grant funding data from the National Institutes
(GME) accreditation system. Summary data showed that of Health (NIH) RePORT database [13] showed that COMs
99.29% of spring 2020 graduates successfully placed in secured 102 grants out of a total of 93,243 active grants,
GME, with 6,815 new DOs beginning their residencies in equaling 0.1% of all NIH funded grants in the US. While
July 2020 [3]. Over the long term, efforts to sustain this high bias toward COMS may play a role in this stark discrep-
placement rate in GME will be crucial. ancy, the research environment, investigator training,
and previous research experience also contribute to
In the “single match,” DOs participate with graduates lower research productivity. Likewise, many graduating
from US allopathic medical schools (USMDs) and inter- seniors believe the research environment and opportu-
national medical graduates (IMGs). These GME positions nities for participating in research to be insufficient.
are open equally to DOs, USMDs, and IMGs, thereby Nearly half (47%) of 2020 DO graduates felt the amount of
making these positions more competitive than they pre- time devoted to research during their academic training
viously were. Program directors evaluate DO and MD was “inappropriate.” [14] Further, they reported that a
applicants on their academic performance via multiple scant 3% of their time was dedicated to research during
metrics, including board examination scores, letters of their clerkship years. Insufficient training and time
recommendation, medical student performance evalua- devoted to research was reflected in the 2020 NRMPdata.
tions, personal statements, professionalism, and research The average number of research experiences among
experience [4]. In the 2018 National Resident Matching matched MD seniors was 3.5, compared with 1.9 among
Program (NRMP) Director survey, program directors rated DO seniors [15, 16]. Furthermore, MD seniors reported an
research experience with a mean importance of 3.7 out of average of 6.9 abstracts, presentations, and publications,
5 when selecting applicants to interview [4]. Research whereas DO seniors reported an average of 2.9 [15, 16].
experience conveys a set of intangible skills desirable to These data demonstrate that the osteopathic medical
program directors. These skills include interdisciplinary community continues to lag behind the allopathic com-
teamwork, critical thinking, problem-solving, time man- munity in the conduct of research (and the infrastructure
agement, and conflict resolution [5, 6]. For applicants to support it).
with comparable board examination scores, evaluations,
and letters of recommendation, the deciding factor may While these data are discouraging, they can serve as the
be research experience. Increasingly, osteopathic medi- catalyst for transformation. Simply put, challenges represent
cal students recognize the value of research in applying lessons to be learned. In 2014, Clark and Blazyk [10] outlined
for residency and express an interest to participate four strategies for the profession and its leaders to commit to a
research culture that promotes “inquiry and scientific
*Corresponding author: Dr. Elizabeth A. Beverly, PhD, Department of exploration.” They recommended: (1) investment in faculty
Primary Care, Ohio University Heritage College of Osteopathic with explicit expectations and accountability for research
Medicine, 1 Ohio University, Irvine Hall 307, Athens, OH, 45701, USA, productivity; (2) additional training and support to foster a
E-mail: [email protected] research culture; (3) increased instruction in research meth-
odology and student mentoring; and (4) comprehensive
research accreditation standards [10]. Given the financial

Open Access. © 2020 Elizabeth A. Beverly, published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0
International License.

334 Beverly: Building an osteopathic research culture

consequences of the novel coronavirus 2019 pandemic and Disclaimers: Dr. Beverly, who is a Section Editor for
the limitations of constrained curricula, these recommenda- Journal of Osteopathic Medicine, was not involved in peer
tions may need to be deferred in short-term. In the interim, the review of this manuscript nor the decision to publish it.
osteopathic community can focus its efforts on identifying
and examining its own research culture. References

Research culture is a set of values, beliefs, assump- 1. American Osteopathic Association. Osteopathic medical
tions, and behaviors about research in an organization profession report. Available from: https://osteopathic.org/wp-
[17, 18]. Analogous to teaching culture, in which there are content/uploads/OMP2019-Report_Web_FINAL.pdf [Accessed 9
values and styles of teaching, research culture reflects the Feb 2021].
values and styles for the implementation of research. Al-
lopathic medical schools have a long, storied history of 2. AACOM Research Reports. Total enrollment by gender
providing a supportive research culture where research is 1968–2020. Available from: https://www.aacom.org/reports-
expected, produced, shared, and valued [19]. For COMs to programs-initiatives/aacom-reports [Accessed 15 Feb 2021].
catch up to allopathic medicine and other health pro-
fessions, we must recognize the importance of cultivating 3. American Association of Colleges of Osteopathic Medicine.
a research culture as, among other things, an investment Report on osteopathic medical school GME placements in 2020
in our future. First, the osteopathic medical community matches. Available from: https://www.aacom.org/docs/default-
must engage in a careful process of introspection to source/data-and-trends/2020_gme-match-report.pdf?
determine who we are as researchers and what type of sfvrsn=bfe20c97_14 [Accessed 9 Feb 2021].
research is important to us. Second, we must define a
research culture for ourselves. We can achieve this by 4. National Resident Matching Program. Data Release and Research
exploring our individual, leadership, and institutional Committee: results of the 2018 NRMP Program Director Survey.
perceptions about the implementation of research. Of Washington, DC: National Resident Matching Program; 2018.
note, an article [20] in this issue covers exactly that type of
exploration; Hamby et al. report the results of a survey 5. Scott-Ladd B, Chan CCA. Using action research to teach students
assessing the experiences and opinions of 70 mentors in a to manage team learning and improve teamwork satisfaction. Act
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research. 7. Carter L, McClellan N, McFaul D, Massey B, Guenther E, Kisby G.
Assessment of research interests of first-year osteopathic
In closing, I have been fortunate to work at both an medical students. J Am Osteopath Assoc 2016;116:472–8.
allopathic medical school and a COM. When I made the
decision to come to my current institution, it was with a clear 8. Amgad M, Man K, Tsui M, Liptrott SJ, Shash E. Medical student
understanding of osteopathic principles and practices. research: an integrated mixed-methods systematic review and
Anecdotally, my family physician growing up was a DO. meta-analysis. PloS One 2015;10:e0127470.
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conversation. When I was struggling with a particular sports 9. Cruser DA, Dubin B, Brown SK, Bakken LL, Licciardone JC,
injury, she told me that she was going to listen to my body so Podawiltz AL, et al. Biomedical research competencies for
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Health and Primary Care at Journal of Osteopathic Medicine.
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13. Research Portfolio Online Reporting Tools (RePORT). Available
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14. American Association of Colleges of Osteopathic Medicine. 2019–
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J Osteopath Med 2021; 121(4): 337–348

Behavioral Health Original Article

Adam W. Hanley*, PhD, Eric L. Garland, PhD and Rebecca Wilson Zingg, DO

Mindfulness-based waiting room intervention for
osteopathic manipulation patients: a pilot
randomized controlled trial

https://doi.org/10.1515/jom-2020-0186 capturing both pleasant and unpleasant sensation were
Received July 17, 2020; accepted November 9, 2020; collected before and after the OMT session. Session satis-
published online February 24, 2021 faction was also assessed with a single survey item.
Results: A total of 57 participants were enrolled in the
Abstract study; however, 18 were unable to listen to the full audio
recording and were excluded from further analysis. The
Context: Osteopathic manipulative treatment (OMT) and final study sample consisted of 39 patients, with 19 (48.7%)
mindfulness-based interventions are both efficacious pain randomized to the history audio recording and 20 (51.3%)
management strategies. Combining these two therapeutic randomized to the mindfulness recording. The mean age of
approaches may offer added benefits to pain patients. patients was 57 years (standard deviation, 11.75 years); 25
Objectives: To determine whether engaging in a (64.1%) were women and 14 (35.9%) were men. The most
mindfulness-based intervention before an OMT session common primary pain location was the neck (16; 41.0%),
improved OMT session outcomes. followed by back (12; 30.8%) and joint (5; 12.8%). Twenty
Methods: Patients seeking OMT care from a single osteo- (51.3%) participants were cancer patients; 19 (48.8%) did
pathic physician at an integrative health clinic were not have a cancer diagnosis. Practicing mindfulness before
recruited for this pilot randomized, controlled trial at an OMT increased patients’ sense of mindful connection to
academic hospital. All patients scheduled for osteopathic (p=0.036) and safety within (p=0.026) their bodies as well
structural evaluation and treatment with the provider from as their overall session satisfaction (p=0.037). Addition-
March 2019 to September 2019 were eligible and invited to ally, OMT paired with either study condition (mindfulness
participate during the reminder call before their visit. vs. history) decreased pain (p<0.001) and increased the
Participants were randomly assigned to listen to one of two ratio of pleasant to unpleasant sensations reported by pa-
audio recordings matched for length: (1) the history of tients (p<0.001). Finally, regardless of experimental con-
osteopathic medicine, or (2) a guided mindfulness medi- dition (mindfulness vs. history), increased safety within
tation practice. Patients completed surveys including the body predicted greater pain relief (β=−0.33, p=0.035)
numeric rating scales to measure mindfulness and and larger sensation ratio changes (β=0.37, p=0.030) at the
embodied safety (a self-reported feeling that the patient’s OMT session’s end. Additionally, increased mindful
body was in a safe place) immediately before and after connection to the body predicted less pain (β=−0.41,
listening to the audio recording. A global pain rating report p=0.005) at the session’s end.
along with a sensation manikin (a digital human figure Conclusions: This study demonstrated the feasibility of
silhouette overlaid with a grid of 786 “sensation” pixels) integrating a mindfulness-based intervention with OMT
and results suggest that having patients listen to an audio-
*Corresponding author: Adam Hanley, PhD, College of Social Work’s guided mindfulness practice while waiting for their OMT
Center, Mindfulness and Integrative Health Intervention session may increase their mindful connection to and
Development, University of Utah, 395 South 1500 East #111, Salt Lake safety within their bodies as well as their session satisfac-
City, UT 84112-8909, USA, E-mail: [email protected] tion. This study also provides empirical evidence that OMT
Eric L. Garland, PhD, College of Social Work’s Center, Mindfulness and may increase the distribution of pleasant sensations re-
Integrative Health Intervention Development, University of Utah, Salt ported by pain patients while decreasing the distribution of
Lake City, Utah, USA; and University of Utah, Salt Lake City Veterans unpleasant sensations reported.
Affair Medical Center, Salt Lake City, Utah, USA
Rebecca Wilson Zingg, DO, Division of Physical Medicine and Keywords: chronic pain; meditation; mindfulness; OMT;
Rehabilitation and the Huntsman Cancer Institute Wellness and osteopathic manipulative treatment; patient satisfaction.
Integrative Health Center, University of Utah, Salt Lake City, Utah, USA

Open Access. © 2020 Adam W. Hanley et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0
International License.

338 Hanley et al.: Waiting room mindfulness for OMT patients

Between 20 and 30% of US adults have chronic pain [1, 2], state of mindfulness can be cultivated through a variety of
and many seek pain relief through pharmacological and practices (e.g., mindfulness meditation, yoga, centering
behavioral means. Opioid analgesics are among the pri- prayer), many of which use a “mindful object,” such as the
mary pharmacological treatments of chronic pain; howev- breath or the body, to stabilize attention in the present
er, widespread opioid prescription has resulted in rapidly moment [27, 28]. Evidence suggests this attentional stance
rising rates of opioid misuse, addiction, and overdose [3–5]. can provide stress [29, 30] and pain relief [29, 31–33]. By
Consequently, clinical practice guidelines strongly suggest focusing on the breath or the body, pain is no longer the
that behavioral pain management strategies should be first- focus of attention and mental elaboration about pain (e.g.,
line treatments for chronic pain [6–9]. In contrast with the catastrophizing) decreases; thus, emotional reactions to
poor long-term efficacy and iatrogenic risks of available pain also decrease [34–36]. Furthermore, by virtue of
analgesic pharmacotherapies [10], osteopathic manipula- cultivating nonreactivity during mindfulness practice,
tive treatment (OMT) [11–16] and mindfulness-based in- pain and stress emerge as momentary and fleeting expe-
terventions are emerging as valuable methods of managing riences passing through the larger field of awareness. As
chronic pain [17–19]. The potential positive impact on such, mindfulness may uniquely prepare patients for OMT
cognitive impairment and psychiatric conditions (anxiety, by quieting the mind, relaxing the physical body, and
depression) in patients with pain are additional areas of loosening illness-related cognitive schemas that may help
interest for applying these interventions. maintain pain in the body [20].

Parallel lines of research have suggested that OMT and One study [37] of 147 patients empirically examined the
mindfulness-based interventions can be efficacious pain effects of combining a mindfulness-based intervention with
management strategies [20]. Limited empirical work has OMT; in it, core concepts from acceptance and commitment
examined the efficacy of combining these two therapeutic therapy (ACT) [38, 39], a third-wave cognitive behavioral
approaches, despite theoretical work suggesting they are therapy approach, were introduced to patients with pain
highly compatible [20]. Osteopathic philosophy espouses during the first 15 min of six successive OMT sessions. Re-
the fundamental tenets that the body is a unit, structure sults indicated that the combined mindfulness-based
and function interrelate, and the body has self-healing and intervention and OMT approach improved pain. Further-
self-regulatory mechanisms [21]. In combination with life- more, patients found this combined approach acceptable,
style optimization (exercise, diet, sleep, and stress man- with 60 (95%) of those completing the follow-up question-
agement), OMT uses a variety of techniques to address naire reporting satisfaction with their overall experience and
restrictions in the tissues and optimize how the body outcomes [37]. However, these results [34] were from was a
functions and clears disease [22]. In application to pain single arm study without a randomized control condition,
management, osteopathic manipulation aims to resolve and thus, continued research is needed to investigate the
dysfunction in the tissues that are contributing to pain additive benefit of a mindfulness-based intervention.
generation. OMT may be considered in application to bony Additionally, as ACT emphasizes a variety of therapeutic
alignment, myofascial freedom and mobility, nerve trans- components including values clarification and activity
mission, ligamentous and membranous motion, visceral planning [38, 39], it has thus far been unclear whether
function, and fluid flow [23]. But, as pain is a bio- mindfulness provides unique additive benefit for OMT
psychosocial phenomenon [24, 25], management ideally patients.
addresses not only physical restrictions but also pain-
associated mental patterning in comprehensive manner, In this study, we sought to extend the valuable pre-
which includes but is not limited to emotional and liminary work of Carnes et al. [37] by examining whether
memory-based associations, attentional restrictions that engaging in a single, brief mindfulness meditation practice
limit sensory perception, and physical sense of safety and before an OMT session improved OMT session outcomes.
embodiment (i.e., the patient’s connection to his or her We expected that patients randomized to listen to a brief
body). These phenomena may further contribute to and audio-guided mindfulness meditation practice before their
perpetuate pain as a global state of disease, dysfunction, OMT session would evidence an increased state of mind-
and disintegration. As such, entering an OMT session in a fulness and embodied safety (a self-reported feeling that
state of mindfulness may enhance the therapeutic effects of the patient’s body was in a safe place) immediately after
OMT by broadening the scope of treatment to more directly listening to the recording as well as greater pain relief and
include both body and mind. session satisfaction at the OMT session’s end, compared
with participants who listened to an audio-recording of the
Mindfulness is commonly defined as intentionally and history of OMT. We also expected that increases in mind-
nonreactively attending to the present moment [26]. The fulness and embodied safety occasioned by the presession

Hanley et al.: Waiting room mindfulness for OMT patients 339

mindfulness audio recording would predict greater pain symptoms (i.e., pain, fatigue, nausea, and health), mindfulness of
relief and session satisfaction at the OMT session’s end. the body, and embodied safety. Immediately after listening to the
audio recording, but before their OMT session began, participants
Methods again completed the mindfulness of the body and embodied safety
items. After their OMT session ended, participants again completed
This study was a single site, two-arm, parallel group, pilot randomized the sensation manikin and the pain numeric rating scale. Again, all
controlled trial (trial registry: NCT04477278). All procedures were surveys were completed on a tablet via the Qualtrics survey platform,
approved by the University of Utah institutional review board. Par- which also securely stored all study data in an online repository.
ticipants provided informed consent after reviewing an informed Deidentified participant data were analyzed using SPSS 26 and
consent cover letter with study personnel. AMOS 26 (IBM). Study personnel and the osteopathic treatment
provider (R.W.Z.) were blind to condition.
Participants were patients seeking OMT from a single physician
(R.W.Z.) at a National Cancer Institute designated comprehensive Osteopathic evaluation and treatment were performed by a single
cancer center. The Wellness and Integrative Health Center, in which provider (R.W.Z.) who completed a predoctoral fellowship in osteo-
OMT was provided in this pilot study, exists on the first floor of the pathic manipulative medicine during medical school training prior to
Huntsman Cancer Institute (HCI) where it is well-integrated with other a residency in Physical Medicine and Rehabilitation (PM&R), and who
outpatient clinics and inpatient treatment. While specializing in is board certified through the American Board of Physical Medicine
cancer care, this clinic provides certain services to select patients and Rehabilitation (ABPMR). Following residency completion, this
without cancer diagnoses (including caregivers and staff). Seamless provider (R.W.Z.) had continuous clinical practice at the Huntsman
integration within the HCI framework affords the benefits of broader Cancer Institute Wellness and Integrative Health Center, where she
awareness of past and current medical problems (through the elec- provides osteopathic structural evaluation and management of
tronic medical record), interprovider communication, and referral as musculoskeletal conditions as well as physician evaluations for an
needed for additional interventions and support. As potential con- exercise-based program (POWER: Personal Optimism with Exercise
cerns regarding implementation of mindfulness-based intervention Recovery) for cancer rehabilitation [41].
included active psychosis or current uncontrolled substance abuse, all
participating patients were screened for any changes in medical Patient OMT sessions lasted approximately 30–40 min. All perti-
condition and other, current clinical symptoms upon intake; addi- nent regions of somatic dysfunction were noted in associated di-
tional, more specific screening may be considered in future studies as agnoses; osteopathic findings that correlated with these regions
indicated. were listed in addition to a more generalized, neuromusculoskeletal
examination. Treatment was individualized based on these findings
All patients scheduled for osteopathic structural evaluation and through implementation of a variety of osteopathic techniques
treatment with the provider from March 2019 to September 2019 were (osteopathic cranial manipulative medicine, myofascial release,
eligible and invited to participate during the reminder call before their balanced ligamentous tension, balanced membranous tension,
visit. Both new and established patients were included and contrib- muscle energy, facilitated positional release, Still technique, coun-
uted to a study population that was heterogeneous regarding primary terstrain, and biodynamic osteopathy).
pain location, pain duration (acute vs. chronic), and pain medication
use. Measures

While waiting for their OMT session, participating patients were Sociodemographic and diagnostic information was obtained from
provided a tablet computer and a pair of noise-cancelling head- patient medical records. Due to time limitations, only a single item was
phones. At the study’s end, participants returned both the tablet and used for each of the mindfulness, embodied safety, and session
headphones to clinic staff. Computer-generated randomization satisfaction measurements. The item for each was selected for face
within the Qualtrics survey platform (SAP SE) was used to allocate validity.
participants (1:1) to listen to one of two audio recordings matched for
length (8 min and 13 s): (1) the history of osteopathy, and (2) mind- Clinical symptoms: Self-reported pain, fatigue, nausea, and health
fulness meditation. The history of osteopathic medicine recording were measured with individual respective items rated on a numeric
introduced patients to the founder, Andrew Taylor Still, and his rating scale (0–10), a widely used and validated approach to
philosophy of healing (Supplemental Material). The mindfulness measuring clinical pain and related symptoms [40, 42].
meditation consisted of instruction in focused attention on breath
and body sensations and metacognitive monitoring and acceptance Sensation manikin: The sensation manikin (Figure 1) is a digital human
of discursive thoughts, negative emotions, and pain. This script figure silhouette overlaid with a grid of 786 “sensation” pixels. Participants
closely followed a standardized mindfulness induction script (Sup- identified locations (i.e., grid pixels) on the manikin where they felt both
plemental Material) validated in prior research on brief, in-person pleasant and unpleasant sensations. Clicking once on any grid pixel turned
mindfulness-based interventions for pain in medical settings [40]. To that location blue, indicating a pleasant sensation. Clicking twice on any
minimize potential confounding factors (i.e., variance in vocal tone, grid pixel turned that location red, indicating an unpleasant sensation.
pace, etc.) the same person (A.W.H.) was recorded reading both Each participant was instructed to color the entire area in which they were
scripts. Before listening to the audio recording, patients completed a currently feeling sensation in their body. A clinically useful sensation ratio
brief survey on the tablet via the Qualtrics survey platform that score was achieved by dividing the number of pleasant sensation pixels
included a sensation manikin, which is described in a subsequent reported by the number of unpleasant sensation pixels reported [36].
section of this article, and single items assessing relevant clinical

340 Hanley et al.: Waiting room mindfulness for OMT patients

Mindfulness of the body: Mindfulness of the body was measured with recording and were excluded from further analysis. The
an individual item (“I felt in contact with my body”) from the State final study sample consisted of 39 patients, with 19 (48.7%)
Mindfulness Scale [43] rated on a numeric rating scale (0–10). Due to randomized to the history audio recording and 20 (51.3%)
time limitations, only a single item was used from this scale and was randomized to the mindfulness recording. The mean age of
selected for its face validity. patients was 57 years (standard deviation, 11.75 years); 25
(64.1%) were women and 14 (35.9%) were men. The most
Embodied safety: Embodied safety was measured with an individual common primary pain location was the neck (16; 41.0%),
item (“I felt my body was a safe place”) from the Multidimensional followed by back (12; 30.8%) and joint (5; 12.8%). Twenty
Assessment of Interoceptive Awareness [44] rated on a numeric rating (51.3%) participants were cancer patients; 19 (48.8%) did
scale (0–10). not have a cancer diagnosis. Most (32; 82.1%) had previ-
ously received OMT from the study’s osteopathic physician
Session satisfaction: Session satisfaction was measured with an in- (R.W.Z.). Relatively mild pain levels were observed in this
dividual item (“I am satisfied with my treatment session”) rated on a sample at baseline (x=4.49, SD=1.79) [51] along with rela-
numeric rating scale (0–10). tively high levels of self-reported mindfulness of the body
(x=7.59, SD=1.96). Demographic and baseline characteris-
Statistical analysis tics for all outcomes measures are shown in Table 1.

Between-group differences in pain, sensation ratios, mindfulness of Across the entire sample at baseline, neither mind-
the body, and embodied safety were examined with a multivariate fulness of the body nor embodied safety were correlated
analysis of covariance (ANCOVA). Multivariate ANCOVA allows for the with pain intensity or the sensation ratio. However,
comparison of one or more grouping variables across multiple out- baseline sensation ratio scores and pain ratings were
comes using a single statistical test, thereby decreasing family wise inversely correlated (r=−0.46, p=0.005). There were no
error [45, 46]. Experimental condition (history of osteopathic medicine between-group differences in any of the variables of in-
vs. mindfulness meditation) was used to predict the four outcomes terest at baseline (Table 1).
after covarying baseline values and health status. In accordance with
the classical ANCOVA approach for analyzing randomized controlled A multivariate ANCOVA was used to examine the ef-
trial outcomes [47], covarying baseline values performs statistical fects of the presession audio-guided mindfulness practice
matching on the prerandomization scores and ensures that compari- on (1) patients’ mindfulness of the body and embodied
sons of postrandomization values by treatment group are independent safety immediately after listening to the audio recording as
of baseline differences. Furthermore, given the heterogeneity in pa- well as (2) pain, sensation ratio (i.e., pleasant sensation/
tients’ diagnostic history and stage of care, we also adjusted for health unpleasant sensation), and session satisfaction at the
status (i.e., cancer diagnosis and self-reported cancer symptom). session’s end (Table 2).
While the hospital where this study was conducted specializes in
cancer care, not all patients in this study had a cancer diagnosis. For With respect to the immediate effects of the presession
those outcomes not differing by experimental condition, a repeated audio recording, results revealed that experimental con-
measures analysis of variance (ANOVA) was used to explore main dition (mindfulness vs. history) had an effect on mindful-
effects of time. F-tests, which denote the ratio of two variances ness of the body (F1,31=4.80, p=0.036, partial η2=0.134) and
(i.e., variation between sample means/variation within the samples) embodied safety (F1,31=5.48, p=0.026, partial η2=0.150),
[45], were used to evaluate the effect of experimental condition on adjusting for baseline values and health status. Partici-
pain, sensation ratios, mindfulness of the body, and embodied safety. pants in the mindfulness condition reported greater
The larger the F-statistic, the stronger the evidence that the experi- mindfulness of the body (mindfulness sample mean
mental conditions differed. To facilitate interpretation of the x=8.05, SD=2.19; history x=7.11, SD=2.51) and embodied
F-statistics, we report standardized effect size estimates in the form of safety (mindfulness x=9.05, SD=1.23; history x=7.63,
partial η2: small effect = 0.01; medium effect = 0.06; and large ef- SD=2.65) compared with participants in the history
fect = 0.14 [48]. Finally, path analysis was used to examine whether condition.
presession mindfulness-induced changes mediated the effect of con-
dition on outcomes. Three fit indices were used to evaluate model fit: With respect to the effects of the presession recording on
the χ2 value (χ2), the comparative fit index (CFI) [49], and the root mean session outcomes, results revealed that experimental con-
square error of approximation (RMSEA) [50]. A χ2 test with p> 0.05, dition (mindfulness vs. history) had an effect on session
indicating consistency between the predicted model and observed satisfaction (F1,31=4.76, p=0.037, partial η2=0.133), but not
data, along with CFI greater than 0.90 and RMSEA less than 0.08, on pain (F1,31=0.33, p=0.571, partial η2=0.010) or sensation
suggested adequate model fit. ratio (F1,31=0.13, p=0.727, partial η2=0.004), adjusting for
baseline values and health. While participants in the
Results mindfulness condition reported greater session satisfaction
(mindfulness x=10.00, SD=0.00; history x=9.78, SD=0.55)
A total of 57 consecutive participants were enrolled in the
study; however, 18 were unable to listen to their full audio

Hanley et al.: Waiting room mindfulness for OMT patients 341

Table : Baseline characteristics of participants by treatment group.

N Total History Mindfulness Test statistic p-value
Sociodemographic characteristics
Age, years, mean (SD)    t=. .
Age range, years … …
Women, n (%) . (.) . (.) . (.) Χ=.
Men, n (%) – – – .
Primary pain location, n (%) χ=.
 (.%)  (.%)  (.%) … .
Back pain  (.%)  (.%)  (.%) … …
Joint pain … … … …
Neck pain …  (.%)  (.%) … …
Other  (.%)  (.%)  (.%) Χ=. …
Cancer diagnosis, n (%)  (.%)  (.%) χ=.
Returning patient, n (%)  (.%)  (.%)  (.%) .
Baseline measures of study outcomes  (.%)  (.%) t=. .
Mindfulness of the body, mean (SD)  (.%) t=.
Embodied safety, mean (SD)  (.%)  (.%)  (.%) t=. .
Pain, mean (SD)  (.%) t=. .
Sensation ratio, mean (SD)  (.%) . (.) . (.) .
. (.) . (.) .
SD, standard deviation. . (.) . (.) . (.)
. (.) . (.) . (.)
. (.)
. (.)

compared with participants in the history condition, the The model fit the data well (χ2=2.70, p=0.61, CFI=1.00,
clinical significance of this difference is unclear. RMSEA<0.001). Experimental condition had direct effects
on change in mindfulness of the body, change in embodied
Follow-up repeated measures ANOVA revealed that safety, and session satisfaction. Additionally, change in
although experimental condition did not impact pain or mindfulness of the body and change in embodied safety
sensation ratio changes, main effects of time were observed had direct, inverse effects on change in pain. Furthermore,
for both outcomes (pain: F1,36=59.96, p<0.001, partial change in embodied safety had a direct positive effect on
η2=0.625; sensation ratio: F1,37=19.21, p<0.001, partial change in sensation ratio.
η2=0.342). Regardless of experimental condition, OMT
decreased pain (T1: x=4.50, SD=1.81; T2: x=2.71, SD=1.64; Discussion
39.7% decrease) and increased sensation ratios (T1:
x=0.95, SD=1.99; T2: x=10.36, SD=13.68; 990.5% increase). The patient interview for pain management frequently fo-
The spatial distribution of unpleasant sensations (Figure 1) cuses on pain itself. While much information is gathered
decreased from pre- to postsession (T1: x=29.21, SD=41.51; regarding pain generation and exacerbating/relieving
T2: x=6.82, SD=10.49; 76.6% decrease) while pleasant measures, this interrogation can also serve to further
sensations increased (T1: x=13.41, SD=24.55; T2: x=45.92, amplify the attentional focus and adhesiveness of mind to
SD=85.26; 242.4% increase). unpleasant sensation. According to Andrew Taylor Still,

Finally, path analysis (Figure 2) was used to examine
relationships between the primary variables of interest.

Table : Study outcomes by treatment group.

History Mindfulness Test statistic, F p-Value Effect size, partial η

Presession audio recording outcomes . (.) . (.) . . .
Mindfulness of the body, mean (SD) . (.) . (.) . . .
Embodied safety, mean (SD)
Session outcomes . (.) . (.) . . .
Pain, mean (SD) . (.) . (.) . . .
Sensation ratio, mean (SD) . (.) . . .
Session satisfaction, mean (SD) . (.)

aPartial η: small effect = ., medium effect = ., and large effect = . []. SD, standard deviation.

342 Hanley et al.: Waiting room mindfulness for OMT patients

Figure 1: Sensation reports immediately
before and after OMT. Blue represents
pleasant sensations. Red represents
unpleasant sensations. Color intensity
reflects the frequency of sensation reports
in a given sensation pixel. OMT,
osteopathic manipulative treatment.

MD, DO, the founder of osteopathic medicine: “To find with tools that support health and wholeness in body and
health should be the object of the doctor. Anyone can find mind.
disease.” [52] Through integration of OMT and mindful-
ness, focus is placed on reclaiming attentional control, Results from the present study suggest that listening to
broadening the physical map of pleasant and unpleasant a brief, audio-guided mindfulness instruction prior to OMT
sensation, resolving tissue restrictions to restore physio- increased patients’ sense of mindful connection to and
logical integrity and function, and empowering the patient safety within their bodies. These qualities of mindfulness
are likely to facilitate healing, as physical traumas

Figure 2: Path model depicting study
timeline and relationships between primary
variables of interest. Non-significant paths
were removed from this figure to improve
visual clarity. OMT; osteopathic manipula-
tive treatment.

Hanley et al.: Waiting room mindfulness for OMT patients 343

(i.e., injury, disease), which are often the impetus for more likely to sustain their therapeutic involvement and
seeking OMT, invariably have both physical and psycho- realize more substantive and lasting therapeutic gains.
logical consequences. Indeed, injury and disease can make This therapeutic involvement may include both passive,
the body feel foreign and unsafe [53, 54], resulting in a hands-on treatment as well as active engagement of
tendency for patient to fear and avoid specific body parts or change in home behaviors that support health and pain
the body as a whole. As such, healing may be enhanced by management (e.g., therapeutic exercises, dietary change,
including complementary, therapeutic interventions regular mindfulness practice, sleep optimization, and
capable of cultivating a positive sense of connection with stress management).
the body and nurturing the belief that the body is once
again a safe place. Our results indicate that a brief, pre- Future research is needed to test this hypothesis,
session, audio-guided mindfulness practice can encourage examining whether OMT patients who complete a pre-
positive psychological changes and more intensive mind- session mindfulness practice before their first OMT session
fulness training could further amplify these outcomes. For continue hands-on treatment over time and report greater
example, future studies could increase the “dosage” of health benefits than those not receiving additional,
mindfulness practice by pairing a standardized 8-week mindfulness-based interventions. Through the combina-
mindfulness based intervention, such as Mindfulness tion of a mindfulness-based intervention with OMT, the
Based Stress Reduction [26] or Mindfulness Oriented Re- patient is introduced to a self-care tool that may provide
covery Enhancement [35], with regular visits. Additionally, home-based, therapeutic use for ongoing pain manage-
regardless of experimental condition, increases in mindful ment. Assessments in future research would ideally survey
connection to and safety within the body predicted greater not only OMT follow-up but also the implementation of and
pain relief and larger sensation ratio changes at the OMT adherence to home-based lifestyle and behavioral changes
session’s end. OMT has demonstrated therapeutic value in based on broader physician recommendations. These may
pain management [11–14] and is a primary recommenda- include generalized conditioning and strengthening exer-
tion for common conditions such as low back pain [9], neck cise; targeted, therapeutic exercise; dietary optimization;
pain, and headaches (cervicogenic and migraine prophy- and ongoing mindfulness use. Such an assessment would
laxis) [55]; however, an exclusive focus on the physical inform the longer-term impact of mindfulness induction on
aspects of pain management and recovery neglects a vital motivation and behavioral change.
dimension of healing. As a potentiating tool for embodi-
ment and safety, mindfulness may serve as a cost-effective, Some patients may dislike the presession mindfulness
inductive tool to encourage patient readiness for hands-on practice, prefer other types of presession psychological
treatment and therapeutic release. interventions, or dislike any type of presession interven-
tion. In the current study, we chose to use an active control
Through this pilot study, we explored how promoting a condition instead of a no-treatment control condition to
healing state of mind before OMT may have beneficial account for nonspecific therapeutic factors, such as clin-
impact on patient experience. Indeed, beyond the acute, ical time and attention, which may have influenced
psychological benefits of the presession mindfulness participant outcomes. Future studies are needed to
practice, results from this study indicated that patients in directly compare whether adding a brief presession
the mindfulness group reported greater OMT session mindfulness practice to a standard OMT session out-
satisfaction, a clinical measure that merits ongoing eval- performs a standard OMT session without any presession
uation in OMT of chronic pain conditions [12, 13, 15, 16]. intervention. Furthermore, research is needed to examine
However, path modeling revealed that neither mindfulness individual characteristics that predict presession psycho-
of the body nor embodied safety mediated the relationship logical intervention responsiveness and alternative pre-
between presession mindfulness and session satisfaction. session psychological interventions (e.g., other styles of
Continued research is needed to investigate other saluto- mindfulness practice, hypnotic suggestion, or breathing
genic mechanisms of mindfulness—such as metacognitive exercises) to better personalize presession psychological
awareness, nonreactivity to internal experiences, or dis- interventions for specific patients to maximize clinical
identification with internal experiences [56]—that could outcomes.
explain why presession mindfulness resulted in greater
postsession satisfaction. OMT paired with either experimental condition
decreased pain and increased sensation ratios (pleasant/
Treatment satisfaction is closely associated with unpleasant). This finding exemplifies the potential thera-
treatment adherence [57], and it may be that by coupling a peutic benefit from OMT in pain management. It also re-
mindfulness-based intervention with OMT, patients will be veals the potential for OMT to foster attentional broadening
within the body, loosening of the attentional anchor of

344 Hanley et al.: Waiting room mindfulness for OMT patients

pain, and experience of pleasant sensation. Through those rooms” [62]. Furthermore, clinic flow was minimally dis-
mechanisms, treatment may eventually resolve the tension rupted as the audio recordings were loaded on the clinic’s
between disintegrated areas of the body (restriction and standard intake tablets. The only added burden was the
openness, pain and pleasantness) and restore a sense of purchase of two sets of headphones by the primary author
wholeness to the patient. It has been well-documented that (A.W.H.). Finally, no adverse experiences occurred during
OMT can decrease pain [11–14, 56] and this study or after the presession mindfulness practice. In our clinical
investigated whether OMT can change the spatial distri- setting, integrating mindfulness-based intervention with
bution of both unpleasant and pleasant sensations. the clinical visit appeared to be both effective and safe;
Changes in the sensation ratio suggest that OMT funda- however, additional safeguards such as in-person delivery
mentally shifted patients’ experiences of their bodies from of the mindfulness-based intervention, could be imple-
disproportionately unpleasant before the OMT session mented with future studies to assure additional screening
(x=0.95) to disproportionally pleasant after the session prior to starting the presession intervention Table 2.
(x=10.36) in this study. Sensation ratios below one indicate
unpleasant sensations predominate in the body, while Limitations
sensations ratios greater than one indicate pleasant sen-
sations predominate. Visual inspection of the mean values The main limitations in this study were the small sample
and the sensation manikin (Figure 1) suggest that OMT had size and the heterogeneity of the sample and treatment
a powerful effect on patients’ experience of embodied method. Future studies with larger sample sizes are needed
sensation; OMT increased the sensation ratio 990.5%. to replicate the observed results. G*Power 3.1 indicated
Furthermore, it was not just decreases in unpleasant sen- that a sample of 54 patients would be needed to adequately
sations driving this ratio change. While the spatial distri- power (β=0.806) a replication study utilizing the same
bution of unpleasant sensations decreased by 76.6% from methodology, assuming an effect size of a similar magni-
pre- to postsession, pleasant sensations increased by tude to our smallest observed effect (partial η2=0.133).
242.4%. These findings may suggest that strategies like Future studies are also needed to examine whether the
OMT that are able to cultivate pleasant sensations may be observed results remain in more homogenous samples.
valuable adjunctive treatments to more traditional pain Although we were able to control for factors likely to differ
management strategies that focus exclusively on pain between OMT patients with and without a cancer diagnosis
reduction. (i.e., fatigue, nausea, and health), future studies that
evaluate a homogenous sample of individuals (cancer-
It is also worth highlighting the feasibility and efficacy related pain, neck or back pain, acute or chronic pain)
of this intervention model. Patients randomized to the would be beneficial to ensure that these findings generalize
mindfulness experimental condition were able to increase to specific populations. While the provider (R.W.Z.) inte-
their mindful connection to and safety within their bodies grated various techniques to address individualized so-
by listening to a brief, audio-recorded mindfulness practice matic dysfunction, this was not considered a weakness in
while sitting in a waiting room in a busy medical hospital. study design, but rather an important application of OMT.
There was no incentive for patients to participate in this Through this approach, treatment was tailored to the
study; patients were offered the opportunity to pass their individual patient and facilitated by an osteopathic
time in the waiting room listening to an audio recording. As physician. Performance of an osteopathic structural ex-
such, the implementation implications from this study are amination and OMT by a single physician (R.W.Z.) through
more direct than what would be expected from a study such individualized treatment may furthermore have
design that compensated patients for their participation. served as a control. However, the limitations of this method
Additionally, with the majority of patients waiting more are that treatment approach is not generalizable to a spe-
than 15 min for their appointments [58, 59], there was cific grouping of techniques or anatomical targets for a
ample time to listen to a brief mindfulness recording, like single pain condition.
the 8-min recording used in the current study. While
studies [58, 60, 61] in multiple medical settings indicate Second, our study was limited by our use of single
that longer clinic wait times translate into lower patient items from validated scales to assess constructs of interest
satisfaction, results from this study demonstrate that this (i.e., mindfulness of the body, embodied safety) instead of
waiting room time could be easily transformed into a space using the full scales from which these items were derived.
for contemplative practice that actually improves patient While psychometric evidence supports the use of single-
satisfaction–turning our waiting rooms into “breathing

Hanley et al.: Waiting room mindfulness for OMT patients 345

item scales to assess a range of psychological constructs mindfulness-based intervention may include increased
[42, 63–65] including mindfulness [66, 67], neither the session satisfaction. However, because this was a pilot
mindfulness of the body item nor the embodied safety item study, replication and future supportive research is needed
have been validated previously for use as single items. to increase confidence in the present study’s findings.
Thus, our mindfulness and embodied safety results should Nevertheless, osteopathic providers may consider psycho-
be interpreted with caution. The time-constraints imposed logical interventions (mindfulness-based intervention,
when researching in a busy academic cancer hospital hypnotic suggestion, breathwork) as valuable, easily
limited our measurement approach. We abbreviated scales accessible, therapeutic tools to prepare patients for their
out of necessity for integration within the standard clinic treatment session and augment session satisfaction. This
flow. We chose the State Mindfulness Scale [43] and the study also demonstrated the sizeable impact of OMT on pain
Mindful Interoceptive Awareness Inventory [44] items and reduction in unpleasant sensation and augmentation of
included in this study for their face validity, selected by the pleasant sensation and increase in overall sensation ratio
lead author (A.W.H.) as the best available options for hy- (pleasant/unpleasant). This finding highlights the impor-
pothesis testing. However, alternative items from these two tance in pain management of incorporating interventions that
scales may have yielded alternative results or functioned augment pleasant sensation and support overall health and
better than the chosen items. Future studies are encour- embodiment. With this, we turn from a singular focus on pain
aged to use the full scales should time allow. Future studies and disease back to a model that supports, facilitates, and
should also consider assessing clinical outcomes over a augments the healthful capacity of the human being.
longer follow-up period, not just immediately after the
OMT session. Research funding: Dr. Garland was supported by a grant
from the National Institutes of Health (No. R01DA042033)
Third, history of OMT experience and mindfulness during the preparation of this manuscript. The funders had
practice involvement are individual difference variables no role in the design and conduct of the study; collection,
that may have influenced the study’s outcomes. Future management, analysis, and interpretation of the data;
researchers should gather more thorough demographic preparation, review, or approval of the manuscript; and
data. This sample’s relatively high self-reported mindful- decision to submit the manuscript for publication.
ness at baseline may have influenced how willing partici- Author contributions: All authors provided substantial
pants were to notice body sensations and how well they contributions to conception and design, acquisition of data,
could understand and follow the audio-recorded mind- or analysis and interpretation of data; all authors drafted the
fulness practice. Examining whether similar results are article or revised it critically for important intellectual
observed in patient populations with lower baseline content; all authors gave final approval of the version of the
mindfulness scores is a valuable avenue for future article to be published; and all authors agree to be
research. accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of
Fourth, emerging evidence suggests that brief, in- the work are appropriately investigated and resolved.
person mindfulness-based interventions for pain may be Competing interests: Dr. Garland is the Director of the
more efficacious than brief, audio-guided mindfulness- Center on Mindfulness and Integrative Health Intervention
based interventions [68]. Thus, future studies employing Development. The Center provides Mindfulness-Oriented
in-person mindfulness instruction before OMT may Recovery Enhancement (MORE), mindfulness-based
demonstrate more substantial effects, although the addi- therapy, and cognitive behavioral therapy in the context of
tional resource burden of in-person instruction should also research trials for no cost to research participants; however,
be considered in study design selection. Dr. Garland has received honoraria and payment for
delivering seminars, lectures, and teaching engagements
Conclusions (related to training clinicians in MORE and mindfulness)
sponsored by institutions of higher education, government
Through this study, we demonstrated the feasibility of clinic- agencies, academic teaching hospitals, and medical centers.
based integration of a mindfulness-based intervention with Dr. Garland also receives royalties from National Association
OMT. Benefits of listening to an audio-guided mindfulness of Social Workers Press (Cary, NC) from the sale of books
practice before OMT may include an increased sense of related to MORE.
embodiment and safety. Posttreatment benefit of a presession

346 Hanley et al.: Waiting room mindfulness for OMT patients

Informed consent: All participants in this study provided 14. Rubinstein SM, De Zoete A, Van Middelkoop M, Assendelft WJ,
informed consent. De Boer MR, Van Tulder MW. Benefits and harms of spinal
Ethical approval: This study was reviewed and approved manipulative therapy for the treatment of chronic low back pain:
by the Institutional Review Board at the University of Utah systematic review and meta-analysis of randomised controlled
and was registered at clinicaltrials.gov (NCT04477278). trials. BMJ 2019;364:l689.

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J Osteopath Med 2021; 121(4): 349–359

Cardiopulmonary Medicine Original Article

Ariana S. Dalgleish, OMS II, Adrienne M. Kania, DO, Harald M. Stauss*, MD, PhD
and Adrianna Z. Jelen, OMS II

Occipitoatlantal decompression and noninvasive
vagus nerve stimulation slow conduction velocity
through the atrioventricular node in healthy
participants

https://doi.org/10.1515/jom-2020-0213 groups that differed in the 15 min intervention. The first
Received August 11, 2020; accepted December 10, 2020; group received OA-D for 5 min, followed by 10 min of rest.
published online February 18, 2021 The second group received 15 min of taVNS. The interven-
tion in the third group that served as a time control group
Abstract (CTR) consisted of 15 min of rest. The RR- and PQ-intervals
were extracted from the EKGs and then used to assess HRV
Context: Management of atrial fibrillation includes either and AV-conduction, respectively.
rhythm control that aims at establishing a sinus rhythm or Results: The OA-D group had nine participants (32.1%),
rate control that aims at lowering the ventricular rate, usu- the taVNS group had 10 participants (35.7%), and the CTR
ally with atrioventricular nodal blocking agents. Another group had nine participants (32.1%). The root mean square
potential strategy for ventricular rate control is to induce a of successive differences between normal heartbeats
negative dromotropic effect by augmenting cardiac vagal (RMSSD), an HRV measure of cardiac parasympathetic
activity, which might be possible through noninvasive and modulation, tended to be higher during the recovery period
nonpharmacologic techniques. Thus, the hypothesis of this than during the baseline recording in the OA-D group
study was that occipitoatlantal decompression (OA-D) and (mean ± standard error of the mean [SEM], 54.6 ± 15.5 vs.
transcutaneous auricular vagus nerve stimulation (taVNS) 49.8 ± 15.8 ms; p<0.10) and increased significantly in the
not only increase cardiac parasympathetic tone as assessed taVNS group (mean ± SEM, 28.8 ± 5.7 vs. 24.7 ± 4.8 ms;
by heart rate variability (HRV), but also slow atrioventricular p<0.05), but not in the control group (mean ± SEM,
conduction, assessed by the PQ-interval of the electrocar- 31.4 ± 4.2 vs. 28.5 ± 3.8 ms; p=0.31). This increase in RMSSD
diogram (EKG) in generally healthy study participants was accompanied by a lengthening of the PQ-interval in
without atrial fibrillation. the OA-D (mean ± SEM, 170.5 ± 9.6 vs. 166.8 ± 9.7 ms;
Objectives: To test whether OA-D and/or transcutaneous p<0.05) and taVNS (mean ± SEM, 166.6 ± 6.0 vs.
taVNS, which have been demonstrated to increase cardiac 162.1 ± 5.6 ms; p<0.05) groups, but not in the control group
parasympathetic nervous system activity, would also elicit (mean ± SEM, 164.3 ± 9.2 vs. 163.1 ± 9.1 ms; p=0.31). The
a negative dromotropic effect and prolong atrioventricular PQ-intervals during the baseline recordings did not differ
conduction. on the three study days in any of the three groups, sug-
Methods: EKGs were recorded in 28 healthy volunteers on gesting that the negative dromotropic effect of OA-D and
three consecutive days during a 30 min baseline recording, a taVNS did not last into the following day.
15 min intervention, and a 30 min recovery period. Partici- Conclusions: The lengthening of the PQ-interval in the
pants were randomly assigned to one of three experimental OA-D and taVNS groups was accompanied by an increase
in RMSSD. This implies that the negative dromotropic ef-
*Corresponding author: Harald M. Stauss, MD, PhD, Department of fects of OA-D and taVNS are mediated through an increase
Biomedical Sciences, Burrell College of Osteopathic Medicine, 3501 in cardiac parasympathetic tone. Whether these findings
Arrowhead Drive, Las Cruces, NM 88001-6056, USA, suggest their utility in controlling ventricular rates during
E-mail: [email protected] persistent atrial fibrillation remains to be determined.
Ariana S. Dalgleish, OMS II, Adrienne M. Kania, DO and Adrianna Z.
Jelen, OMS II, Department of Clinical Medicine, Burrell College of Keywords: atrial fibrillation; heart rate variability; PQ interval;
Osteopathic Medicine, Las Cruces, NM, USA rapid ventricular response; vagal stimulation.

Open Access. © 2020 Ariana S. Dalgleish et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0
International License.

350 Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity

Management of atrial fibrillation entails prevention of For this study, the OMT technique of decompression
thromboembolism and either rhythm or rate control. While of the occipitoatlantal junction (OA-D) was applied. With
rhythm control aims at re-establishing sinus rhythm, the regard to this OMT technique, Giles et al. [5] demonstrated
goal of rate control is to reduce a rapid ventricular rate. an increase in high frequency spectral power of heart rate
Rate control is frequently achieved using medications that variability (HRV), which reflects cardiac parasympathetic
slow conduction through the atrioventricular node, modulation [10]. To the best of our knowledge, the exact
including beta blockers, non-dihydropyridine calcium mechanisms by which OA-D increases cardiac para-
channel blockers, or digoxin. All these classes of drugs sympathetic modulation are unknown. However, OA-D
come with their own set of potential adverse effects, which may improve conditions resulting from an articular
can be particularly bothersome considering the lifelong obstruction in the path of the vagus nerve as it exits the
need for pharmacotherapy. Slowing atrioventricular skull. In addition, a widely held assumption on how OA-D
conduction may also be possible by noninvasive and may affect autonomic tone is through a biomechanical
nonpharmacological techniques that increase cardiac effect on deep cervical fascia overlying the vagus nerve and
parasympathetic tone and/or reduce cardiac sympathetic the sympathetic superior cervical ganglion, although
tone, which would be expected to reduce the ventricular experimental evidence for this assumption is lacking [11].
rate in patients with persistent atrial fibrillation. For An alternative explanation for the vagal effect of OA-D is
example, in a prior study [1], yoga combined with light based on the observation that electrical stimulation of
movements and deep breathing improved quality of life cutaneous C1-C2 afferent nerve fibers in the anatomical
and reduced heart rate in 80 patients with paroxysmal location where OA-D is applied, increases parasympathetic
atrial fibrillation. The bradycardic effect observed in that tone [12]. Thus, it is possible that OA-D activates cuta-
study [1] suggests that the interventions increased cardiac neous receptors innervated by C1-C2 afferent nerve fibers,
parasympathetic tone, but does not necessarily imply a projecting to the central nervous system, which triggers an
negative dromodropic effect, because the PQ-interval efferent reflex response that results in vagal activation.
was not assessed and patients were in sinus rhythm
when heart rate was determined. Likewise, it has been Transcutaneous auricular vagus nerve stimulation
proposed [2] that “mindfulness-based interventions,” (taVNS) is another noninvasive technique that has been
defined by the authors as yoga/tai chi/chigong, and demonstrated to shift autonomic balance towards para-
chiropractic/osteopathic manipulation, may exert anti- sympathetic predominance [13–17] and, therefore, may be
arrhythmic effects in patients with atrial fibrillation useful in patients with persistent atrial fibrillation. The
through a shift in the sympathovagal balance toward innervation of the cavum conchae of the ear by the auricular
predominantly parasympathetic states. branch of the vagus nerve (Arnold’s nerve) [18] provides the
unique opportunity to noninvasively activate afferent
The idea of the present study was that interventions parasympathetic nerve fibers projecting to the nucleus of
that increase cardiac parasympathetic tone will also slow the solitary tract (NTS) [19–21] through taVNS [22, 23].
atrioventricular conduction, which may potentially Functional magnetic resonance imaging (fMRI) studies in
contribute to ventricular rate control in patients with humans [19, 20] have demonstrated that the central pro-
persistent atrial fibrillation. According to the American jections of the auricular branch of the vagus nerve are
Osteopathic Association, “osteopathic manipulative treat- consistent with the classical central vagal projections and
ment (OMT) is a set of hands-on techniques used by osteo- can be accessed noninvasively via the external ear. Direct
pathic physicians to diagnose, treat, and prevent illness or and indirect pathways from the NTS to the dorsal vagal
injury” [3]. OMT has been reported to shift the autonomic nucleus (DVN) and nucleus ambiguous (NA) [21] mediate
balance towards predominant parasympathetic tone [4]. efferent parasympathetic activation in response to taVNS.
Specifically, some OMT techniques that have been shown Specifically, cardiac parasympathetic activation in response
to increase cardiac parasympathetic modulation include to taVNS has been demonstrated through HRV analysis
suboccipital decompression [5], craniosacral techniques [6], [13–15, 17]. Furthermore, long-term taVNS at the site of the
cervical myofascial techniques [7], and fourth ventricle tragus for up to six months reduced atrial fibrillation burden
compression [8, 9]. However, to the best of our knowledge, in patients with paroxysmal atrial fibrillation [24]. This
no data exist that demonstrate that these OMT techniques clinical study [24] demonstrated the therapeutic effective-
not only increase cardiac parasympathetic tone but also slow ness of taVNS for rhythm control in patients with paroxismal
atrioventricular conduction and therefore may potentially be atrial fibrillation. However, it remains unknown whether
useful for ventricular rate control in patients with persistent taVNS is also effective for rate control in patients with
atrial fibrillation. persistent atrial fibrillation. Specifically, it is not known

Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity 351

whether taVNS elicits a negative dromotropic effect through randomized (by rolling a six-sided die [1,2: group 1; 3,4: group 2; 5,6:
its documented effect on cardiac autonomic balance [13–17]. group 3]) into one of three study groups: time control group; (2) OA-D
group, or taVNS group. Each study participant underwent hemody-
Based on these considerations, we retrospectively namic recordings on three consecutive study days. On the first study
analyzed electrocardiogram (EKG) recordings obtained in day, all participants gave written consent, answered a questionnaire
our previous [25] and ongoing studies to test the hypothesis to verify eligibility in the study according to predefined inclusion/
that decompression of the occipitoatlantal junction (OA-D), exclusion criteria (outlined in a subsequent section), and height and
an OMT technique that has been demonstrated to increase body weight were measured. On all three study days, upper arm blood
cardiac parasympathetic tone [5], and taVNS lengthen the pressure was measured (Omron 10 Series; Omron Healthcare, Inc.) in
PQ-interval in the EKG of healthy individuals. In the studies the seated position before the start of the experimental protocol.
from which the EKGs of this study were obtained, we chose During the experimental protocol, a three-lead EKG and finger blood
the OA-D technique over other more advanced OMT tech- pressure (Finapres Finometer Pro; Finapres Medical Systems) were
niques that have also been demonstrated to increase cardiac continuously recorded. The finger blood pressure data were not used
parasympathetic tone, because the OA-D technique is for this study. The experimental protocol on each study day started
included in the curriculum at all colleges of osteopathic with a 30 min baseline recording, followed by a 15 min intervention
medicine and therefore could be utilized by any osteopathic and a 30 min recovery recording (Figure 1). In the time control group,
physician. the intervention consisted of 15 min of rest. In the OA-D group, the
intervention consisted of 5 min of OA-D followed by 10 min of rest. In
the taVNS group, the intervention consisted of 15 min of taVNS.

Methods Study participants

Study groups and experimental protocol EKGs from a total number of 28 generally healthy adults over 18 years
of age were included in the study. Exclusion criteria included: age
For the purpose of the current study, data from two separate studies under 18 years; pregnancy; current alcohol or drug abuse; and any
were retrospectively analyzed. Both studies were approved by the medication or medical condition that may affect the outcome pa-
Institutional Review Board at Burrell College of Osteopathic Medicine rameters or increase the risk associated with taVNS (e.g., tinnitus) or
(IRB# 0046_2019 and IRB# 0054_2019). One of the studies is registered the OA-D intervention. In one of the two studies from which the EKGs
with ClinicalTrials.gov (NCT04177264). All study participants provided were obtained [25] an additional participant was consented and
written informed consent prior to participating in the studies. enrolled who was unaware of her/his condition of persistent atrial
fibrillation. This participant was initially randomized into the taVNS
All study participants were compensated for their time effort with group but then excluded from the study after the second study day.
gift cards. The value of the compensation varied between $20 and Thus, additional EKGs were available from one study participant with
$100 depending on the number of study days and the study in which persistent atrial fibrillation who underwent taVNS on two study days.
participants were enrolled. The data included in this study were The data from this participant are not included in the statistical data
collected between June 2019 and March 2020. Both studies had very analysis of this study, but we refer to the data from this participant in
similar designs and protocols. For both studies, participants were the Discussion.

Figure 1: Original recording from one study
participant in the occipitoatlantal
decompression (OA-D) group. From the
electrocardiogram (EKG, top), the
RR-intervals (middle) and PQ-intervals
(bottom) were derived for each heartbeat
using the HemoLab software. A 30 min
baseline recording was followed by a 15 min
intervention and a 30 min recovery
recording. In the OA-D group, the interven-
tion consisted of 5 min of OA-D followed by
10 min of rest. Note the increase in the
PQ-interval following the OA-D intervention
compared to the baseline recording.

352 Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity

OA-D intervention derived RR-interval and PQ-interval time series were visually inspec-
ted for incorrectly detected P- or Q-waves or for artifacts (due to muscle
OA-D was performed as described in Greenman’s Principles of Manual activity) or ectopic beats. Any incorrectly detected RR-intervals or
Medicine [26]. Briefly, while reaching toward the occipitoatlantal joint, PQ-intervals or artifacts or ectopic beats (less than 1% of detected RR-
the investigators (including A.M.K, as well as first and third year DO or PQ-intervals) were replaced by interpolations based on leading and
students listed in the Acknowledgments) cradled the subjects’ heads trailing values using the Artifact Removal tool implemented in the
with their hands and finger pads along the inferior aspect of inion. Analyzer software [27]. The RR-interval time series were used to
While bringing the elbows together, the investigator then applied calculate the root mean square of successive differences between
gentle anterior and cephalad traction to the occiput for 5 min. normal heartbeats (RMSSD) using the Batch Processor software,
Although the student investigators were well-versed in performing included with the HemoLab software package [27]. For this, the beat-
OA-D, several hours of training were given. These training sessions by-beat RR-interval time series obtained during the baseline re-
also included measuring palpatory forces using scales to develop a cordings (30 min) and during the recovery recordings (30 min) were
sense of palpatory forces and to standardize the pressures and forces divided into 50% overlapping segments of 5 min duration each.
applied during the OA-D intervention. All students were able to RMSSD was then calculated for each of the 5 min segments of the
consistently apply a light (20 g), moderate (40 g), and heavy (60 g) baseline and recovery recordings, respectively, and the RMSSD values
pressure on scales during the training sessions. For this study, a light of all 5 min segments was averaged. These mean RMSSD values were
palpatory pressure (20 g) was used and applied for 5 min. This pressure used for statistical analysis.
(20 g) was verified using force transducers applied to the palpating
fingertips. Finally, following these trainings, there was no discernable Statistical analysis
difference among the students’ application of OA-D when evaluated
by one of the senior investigators with many years of experience in Unless otherwise indicated, data are presented as means ± standard
OMT (A.M.K). error of the mean (SEM). Comparisons between baseline values on the
three study days were done by one-way analysis of variance for
Transcutaneous auricular vagus nerve stimulation repeated measures with post-hoc Fisher tests. Comparisons of data
(taVNS) obtained before (baseline) and after (recovery) the interventions were
done by the nonparametric Wilcoxon test for repeated measures. For
For taVNS, a bipolar clip electrode, connected to a transcutaneous these comparisons, we also computed a retrospective power analysis
electrical nerve stimulator (EMS 7500; Current Solutions, LLC) was using the R statistical analysis software [29] according to Cohen [30].
applied to the cymba conchae of the left ear such that the cathode was Statistical significance is assumed at p<0.05 and trends are described
placed at the cavum of the concha and the anode was placed at the at p<0.10.
opposing site of the back of the auricle. Badran et al. [16] studied
different stimulation frequencies (1, 10, and 25 Hz) and stimulation
pulse widths (100, 200, and 500 µs) and found that the combination of
10 Hz and 500 µs resulted in the greatest bradycardic effect. Since the
longest pulse width of the EMS 7500 device is 300 µs, we used a
combination of 10 Hz stimulation frequency and 300 µs pulse width for
the current study. The stimulation current was determined individu-
ally for each subject by slowly increasing the stimulation current until
the subject felt a mild tingling sensation at the site of the electrode.
Then the current was gradually reduced until the tingling sensation
disappeared or was just barely felt. This current was then applied for
15 min of taVNS (by H.M.S. and first and third year DO students listed
in the Acknowledgments).

Data analysis

A total of 168 EKG recordings (28 subjects, three study days, baseline Figure 2: Extraction of RR-intervals and PQ-intervals using the
and recovery recordings) were analyzed. The Analyzer software, Analyzer module of the freely available HemoLab software [27]. The
included with the freely available HemoLab software [27], was used to software identifies P-waves, QRS complexes, and T-waves (markers
extract the RR-intervals and PQ-intervals from the 168 EKG recordings. in EKG trace). RR-intervals are calculated as the time interval in
This software uses the algorithm described and validated by Elgendi milliseconds between the beginning of the Q-waves of two adjacent
et al. [28] to extract RR-intervals and PQ-intervals from EKG time series QRS complexes. PQ-intervals are calculated as the time interval in
(Figure 2). With this algorithm, RR-intervals and PQ-intervals are milliseconds between the beginning of the P-wave and the begin-
extracted for all heartbeats within the EKG time series. RR-intervals are ning of the subsequent QRS complex.
calculated as the time interval in milliseconds between the beginning
of the Q-waves of two adjacent QRS complexes. PQ-intervals are
calculated as the time interval in milliseconds between the beginning
of the P-wave and the beginning of the subsequent QRS complex. All

Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity 353

Results Effects of OA-D and taVNS on ventricular rate

The OA-D group had nine participants (32.1%); the taVNS In general, the ventricular rate declined throughout the
group had 10 participants (35.7%), and the CTR group had experimental protocol, such that the RR-interval was
nine participants (32.1%). Sex, age, body mass index (BMI), longer during the recovery recording following the inter-
and systolic and diastolic blood pressure data is provided vention compared to the baseline recording before the
in Table 1. None of these parameters differed significantly intervention (Figure 4). In the OA-D group, the RR-interval
between groups. increased in eight of nine study participants (ventricular
rate change, −2.2 ± 0.7 bpm; p<0.10), and in the taVNS
Day-to-day effects of OA-D and taVNS group, it increased in all 10 participants (ventricular rate
change, −2.8 ± 0.6 bpm; p<0.05). However, this decrease in
Study participants completed the experimental protocol ventricular rate cannot be attributed to the OA-D or taVNS
(Figure 1) on three consecutive study days. The baseline intervention, because a similar decrease in ventricular rate
values for the RR-intervals, RMSSD, and PQ-intervals was observed in the control group (ventricular rate
before the control, OA-D, or taVNS interventions for each change: −2.8 ± 0.9 bpm; p<0.05), in which the RR-interval
of the three study days are shown in Figure 3. The baseline increased in eight of nine study participants. Furthermore,
RR-intervals were not significantly different on the three there were no significant differences in the changes in
study days for the control and OA-D groups. For the taVNS ventricular rate from baseline to recovery between the
group, RR-intervals were significantly shorter on the sec- three experimental groups. It is possible that study par-
ond study day and tended to be shorter on the third study ticipants calmed down or relaxed throughout the experi-
day compared to the first study day. However, no signifi- mental protocol, which would be associated with less
cant differences in baseline values for RMSSD and sympathetic tone and a lower ventricular rate.
PQ-intervals were observed between the three study days
in any experimental group. Thus, any potential effects of Effects of OA-D and taVNS on RMSSD
OA-D or taVNS on RMSSD or PQ-interval did not persist into
the following study day. As a consequence, we averaged RMSSD is a time-domain HRV parameter that has been
the values from all three study days for subsequent ana- demonstrated to reflect parasympathetic modulation of
lyses of the effects of OA-D and taVNS on RMSSD and on the cardiac function [10, 31]. Following OA-D (recovery vs.
PQ-interval. baseline recording), RMSSD increased in seven of nine

Table : Participant characteristics.

Parameter Control group (n=) OA-D group (n=) taVNS group (n=)

Sex  (.%)  (.%)  (.%)
Women, n (%)  (.%)  (.%)  (.%)
Men, n (%)  ±  (–)  ±  (–)  ±  (–)

Age, mean ± SEM . ± . . ± . . ± .
(range), years (.–.) (.–.) (.–.)
BMI, mean ± SEM  ±  (–)  ±  (–)  ±  (–)
(range), kg/m
Systolic blood  ±  (–)  ±  (–)  ±  (–)
pressure,
mean ± SEM
(range), mmHg
Diastolic blood
pressure,
mean ± SEM
(range), mmHg

BMI, body mass index; SEM, standard error of the mean. Systolic and diastolic blood pressures were measured at the beginning of the protocol
on all three study days. Blood pressure values were averaged over the three study days. Values are means ± SEM. Numbers in parentheses are
ranges. No significant (p<.) differences between groups were observed in any parameters.

354 Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity

Figure 3: Baseline values for RR-intervals
(RR-I, top), root mean square of successive
differences between normal heartbeats
(RMSSD, middle), and PQ-intervals (PQ-I,
bottom) on the three consecutive study
days (x-axis) in the control group (left), the
occipitoatlantal decompression (OA-D)
group (middle), and the transcutaneous
auricular vagus nerve stimulation (taVNS)
group (right). Data are shown as
mean ± standard error of the mean.
*: p<0.05 vs. Day 1 (*): p<0.10 vs. Day 1.

Figure 4: RR-intervals (top), root mean
square of successive differences between
normal heartbeats (RMSSD, middle), and
PQ-intervals (bottom) before (baseline) and
after (recovery) the control intervention
(control, left), occipitoatlantal decompres-
sion (OA-D, middle), and transcutaneous
auricular vagus nerve stimulation (taVNS,
right). The data from all three study days
were averaged. Data are shown for all in-
dividual subjects (connected circles) and
group means ± standard error of the mean
(circles with error bars). Solid lines indicate
an increase and dotted lines a decrease in
RR-interval, RMSSD, or PQ-interval in the
respective study participant. *: p<0.05
baseline vs. recovery (*): p<0.10 baseline
vs. recovery.

study participants (median: +5.1 ms; 95% CI: −1.1 to did not differ significantly between the three study days in
+10.8 ms; p<0.10; statistical power [1-β]=69%; Figure 4). any group (Figure 3, middle row).
Likewise, following taVNS, RMSSD increased in nine of 10
study participants (median: +2.6 ms; 95% CI: +0.0 to Effects of OA-D and taVNS on PQ-Interval
+8.2 ms; p<0.05; statistical power [1-β]=67%; Figure 4). In
contrast to this significant increase in RMSSD in the taVNS Following OA-D (recovery vs. baseline recording) the
group and the trend toward an increase in RMSSD in the PQ-interval lengthened in eight of nine study participants
OA-D group, RMSSD increased only in five of nine study (median: +4.2 ms; 95% CI: +1.8 to +5.6 ms; p<0.05; statis-
participants in the control group (median: +2.7 ms; 95% tical power [1-β]=97%; Figure 4). Likewise, in the taVNS
CI: −2.6 to +8.5 ms; p=0.31; statistical power [1-β]=25%; group, the PQ-interval lengthened in nine of 10 study
Figure 4). These findings suggest that the OMT techniques participants (median: +4.4 ms; 95% CI: +2.1 to +6.9 ms;
of OA-D and taVNS increase parasympathetic modulation p<0.05; statistical power [1-β]=96%; Figure 4). In contrast,
of cardiac function. However, these acute effects of OA-D following the control intervention the PQ interval length-
and taVNS on cardiac parasympathetic tone did not last ened only in five of nine study participants (median:
into following study day, because RMSSD baseline values

Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity 355

+1.6 ms; 95% CI: −1.1 to +3.6 ms; p=0.31; statistical power inducibility in a rabbit model of atrial fibrillation [32].
[1-β]=20%; Figure 4). Thus, the PQ-interval significantly Human data on the effects of noninvasive vagus nerve
increased following OA-D (+3.7 ± 0.8 ms, p<0.05) and stimulation in patients with atrial fibrillation are scarce.
taVNS (+4.5 ± 1.1 ms; p<0.05), but not following the control However, Stavrakis et al. [33] demonstrated, in patients
intervention (+1.2 ± 1.0 ms; p=0.31). These acute effects of with paroxysmal atrial fibrillation referred to the electro-
OA-D and taVNS on the PQ-interval did not persist in the physiological laboratory for ablation, that 1 h of trans-
next study day, because the baseline values for the cutaneous low-level stimulation of the tragus performed
PQ-interval did not differ significantly between the three during anesthesia suppressed pacing-induced atrial
study days in any group (Figure 3, bottom row). fibrillation duration. The same group of investigators also
conducted a chronic study (TREAT AF Trial) [24] in which
Discussion 26 patients with paroxysmal atrial fibrillation were treated
with noninvasive low level tragus stimulation for 1 h daily
The major finding of this study is that the OMT techniques for up to six months. At six months, the median atrial
of OA-D and taVNS applied for 5 min or 15 min respectively fibrillation burden was 85% lower in the group that
lengthened the PQ-interval during a 30 min EKG recording received tragus stimulation compared to the control group.
that followed the OA-D or taVNS intervention. Since this Thus, there is clinical evidence that noninvasive auricular
lengthening of the PQ-interval was accompanied with a vagus nerve stimulation may contribute to rhythm control
significant increase in RMSSD in the taVNS group and with in patients with paroxysmal atrial fibrillation. In the TREAT
a trend toward an increase in the OA-D group, we speculate AF trial [24], the authors also speculated that the antiar-
that OA-D and taVNS elicited their effects on the rhythmic effect of tragus nerve stimulation may be related
PQ-interval through activation of cardiac parasympathetic to neural remodeling, suppression of inflammation, and an
tone. These results may serve as reference data for future improved sympathovagal balance. These potential mech-
studies testing on whether OA-D and/or taVNS can be anisms are supported by the chronic time course of the
utilized for ventricular rate control in patients with effects of tragus stimulation that are consistent with al-
persistent atrial fibrillation (i.e., when in atrial fibrillation). terations in neural remodeling, a reduction in serum levels
of the proinflammatory cytokine tumor necrosis factor-
One study participant in our taVNS group who had a alpha (TNF-α), and an increase in the LF/HF ratio of HRV in
high ventricular rate (∼100 bpm) as a consequence of the group of patients that received tragus stimulation [24].
persistent atrial fibrillation sparked the idea for this study. Not many studies have investigated the effect of the para-
This person had no knowledge of his arrhythmia when sympathetic nervous system on ventricular rate control in
entering the study. Thus, the person was consented and conditions of persistent atrial fibrillation. In a study by
enrolled in the study. However, the data from this study Jiang et al. [34], left cervical vagus nerve stimulation for
participant were excluded from the statistical data analysis one week (continuous stimulation with cycles of 14 s on
of this study. The ventricular rate of this study participant 66 s off) reduced the ventricular rate in six dogs with
decreased from 99.4 bpm (before taVNS) to 96.0 bpm (after experimentally induced atrial fibrillation by 20 bpm.
taVNS) on the first study day and from 101.9 bpm (before However, it remains unknown whether this beneficial ef-
taVNS) to 97.5 bpm (after taVNS) on the second study day. fect of vagus nerve stimulation is mediated through a
While this finding in a single patient with atrial fibrillation negative dromotropic effect, because the PQ-interval
does not allow any definite conclusions, it provides an cannot be utilized to assess atrioventricular conduction
additional rationale for conducting follow-up studies in in atrial fibrillation. Our study demonstrated that nonin-
patients with persistent atrial fibrillation. vasive taVNS prolonged the PQ-interval in human subjects
in sinus rhythm, which is consistent with a negative dro-
In considering the role of the parasympathetic nervous motropic effect of taVNS. Nevertheless, it remains to be
system in patients with atrial fibrillation, it is important to seen whether taVNS can reduce ventricular rate in patients
distinguish patients with paroxysmal atrial fibrillation with persistent atrial fibrillation through its negative dro-
from patients with persistent atrial fibrillation. The thera- motropic effect.
peutic goal for patients with paroxysmal atrial fibrillation
often entails rhythm control, while ventricular rate control Another important consideration is that the para-
may be appropriate for patients with persistent atrial sympathetic nervous system can induce atrial fibrillation,
fibrillation. With regard to rhythm control, increasing especially in young, aerobically trained patients with
cardiac parasympathetic tone by vagus nerve stimulation structurally normal hearts [35]. In line with this clinical
has been demonstrated to reduce atrial fibrillation observation, right cervical vagus trunk simulation has

356 Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity

been shown to induce atrial fibrillation in dogs that were found a trend (p<0.10) for increased RMSSD following
previously in sinus rhythm [36]. This finding of a proar- application of OA-D, which is an OMT technique that ad-
rhythmic effect of right cervical vagus trunk stimulation in dresses somatic dysfunction within the suboccipital joint.
dogs is in contrast with the TREAT-AF study [24], which Another OMT technique that has been demonstrated to
demonstrated that taVNS reduced atrial fibrillation burden increase cardiac parasympathetic tone is the cranial tech-
in patients with paroxysmal atrial fibrillation (i.e., in pa- nique of the fourth ventricle (CV4) compression. In 30
tients that are mostly in sinus rhythm). A potential expla- study participants, this technique demonstrated an in-
nation for this discrepancy is that right cervical vagus trunk crease in RMSSD and high frequency spectral power of HRV
stimulation elicits a strong and direct activation of efferent in normotensive subjects and a reduction of arterial blood
cardiac vagal nerve fibers, whereas taVNS primarily acti- pressure in hypertensive subjects [8]. To our knowledge, no
vates afferent vagal nerve fibers projecting to the central study exists that directly compares the effects of OA-D and
nervous system. It is possible that efferent vagus nerve CV4 compression on cardiac parasympathetic tone. Before
stimulation is proarrhythmogenic, while afferent vagus considering OMT for ventricular rate control in patients
nerve stimulation is antiarrhythmogenic. It is also possible with atrial fibrillation, it appears important to identify the
that vagus nerve stimulation can be pro- or antiar- OMT technique that has the strongest effect on cardiac
rhythmogenic depending on the stimulation protocol, parasympathetic tone. While the results of our study indi-
including continuous vs. intermittent stimulation, stimu- cate that OA-D increased the PQ duration in healthy study
lation intensity, and stimulation parameters. With this in participants, it is possible that a more pronounced effect
mind, a low stimulation intensity that did not reduce may be obtained with other OMT techniques, such as CV4
resting heart rate while in sinus rhythm (stimulation fre- compression or applying OA-D with a moderate instead of
quency: 20 Hz; pulse width: 200 ms, current: 1 mA below light palpatory pressure.
the level that caused mild discomfort) was used in the
TREAT-AF study [24]. It is unknown whether OA-D in- The lengthening of the PQ-interval in response to OA-D
creases vagal tone through a direct effect on efferent vagal (+3.7 ± 0.8 ms; p<0.05) and taVNS (+4.5 ± 1.1 ms; p<0.05)
nerve fibers (i.e., through an effect on deep cervical fascia observed in our study was relatively small and readers may
overlying the vagus nerve) or through a reflex response to question whether an increase in the PQ interval of less than
activation of cutaneous C1-C2 afferent nerve fibers within 5 ms is clinically significant. It is important to highlight that
the occipital nerve [12]. Because of these uncertainties, it is in normal sinus rhythm, the PQ-interval does not determine
impossible to predict whether OA-D may potentially elicit the ventricular rate. In contrast, in persistent atrial fibrilla-
proarrhythmogenic effects. However, no such adverse ef- tion, the ventricular rate depends on how many atrial ex-
fects were observed in our study and to the best of our citations are conducted into the ventricles. Thus, in
knowledge, no clinical studies exist that have reported persistent atrial fibrillation, the negative dromotropic effect
proarrhythmogenic effects of OA-D. of OA-D or taVNS may reduce the number of atrial excita-
tions that are transmitted into the ventricles, and hence,
Despite an extensive literature search, we did not find reduce the ventricular rate. However, it is difficult to predict
any publication on the effects of OMT on atrioventricular quantitatively how much an increment of the PQ-interval
conduction or on potential effects of OMT on ventricular observed during sinus rhythm – as in our study – would
rate control in patients with atrial fibrillation. However, it is decrease the ventricular rate during atrial fibrillation.
well-established that some OMT techniques can increase Investigating this relationship would require studying the
cardiac parasympathetic tone [5, 8, 37] and therefore may same patients while in sinus rhythm and while in atrial
potentially slow atrioventricular conduction and may be fibrillation. The experimental difficulty with this approach is
effective for ventricular rate control in patients with atrial that patients with persistent atrial fibrillation are usually not
fibrillation. Specifically, Giles et al. [5] demonstrated that in sinus rhythm and patients with paroxysmal atrial fibril-
suboccipital decompression enhanced high frequency lation are mostly in sinus rhythm. In the single study
spectral power of HRV. Like RMSSD, this frequency- participant with persistent atrial fibrillation, taVNS only
domain HRV parameter reflects parasympathetic modula- elicited a modest decrease in the ventricular rate (−3.4
tion of cardiac function [10, 31]. Furthermore, a systematic and −4.4 bpm on the first and second study days, respec-
literature review of the effectiveness of osteopathic treat- tively) while in atrial fibrillation. It is possible that more
ment on the autonomic nervous system concluded that pronounced effects could be achieved by chronic applica-
treatment of the suboccipital region significantly changes tion of OA-D or taVNS, such as daily treatment/application
autonomic nervous system function [37]. Consistent with for one month. Applying OA-D or taVNS twice per day
this conclusion and with the findings by Giles et al. [5], we (i.e., in the morning and evening) instead of just once per

Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity 357

day may also yield larger responses. In addition, the dura- conduction in response to OA-D in subjects in sinus rhythm
tion of the OA-D (5 min) or taVNS (15 min) sessions could be provides a rationale for future studies investigating
increased to potentially yield stronger responses. whether OA-D (or other OMT techniques that affect cardiac
autonomic tone) reduces ventricular rate in patients with
In our study, we chose to apply OA-D as a standardized persistent atrial fibrillation. If this is the case, OMT may be
intervention with similar pressures applied for the same useful as an adjuvant treatment modality in patients with
time duration in each study participant. A more clinical persistent atrial fibrillation.
approach would have been to apply the force needed to
resolve any potential somatic dysfunction only for the time Limitations
required to resolve such dysfunction. The hypothesis of our
study was that OA-D would prolong the PQ-interval Our study had several limitations. First, only generally
through activation of vagal tone. In deciding between a healthy individuals were included in the study. Thus, our
standardized intervention vs. a clinical approach, we study only allowed for speculations on how our findings
considered which strategy would be more likely to elevate may translate to patients with atrial fibrillation. While we
vagal tone. It is established that OA-D increases vagal tone found some evidence for increased cardiac para-
[5]. However, the exact mechanisms underlying this effect sympathetic modulation in response to OA-D and taVNS,
are unknown. While it is possible that the vagal effects of this finding does not allow for the conclusion that the
OA-D are related to the treatment of somatic dysfunction, lengthening of the PQ-interval following OA-D and taVNS
experimental evidence for this possibility is lacking. An is indeed mediated by increased parasympathetic neuronal
alternative explanation is that the vagal effects of OA-D are activity directed to the atrio-ventricular node. Second,
triggered by stimulation of cutaneous afferent nerve fibers OA-D and taVNS were only applied for 5 and 15 min
within the occipital nerves. The occipital nerves provide respectively on three consecutive days. If the effects of
afferent innervation of the skin at the anatomical location OA-D and/or taVNS were mediated, at least partly, through
at which OA-D is applied [38]. Importantly, it has been neural remodeling as suggested by the authors of the
demonstrated that C1-C2 occipital neuromodulation using TREAT AF trial [24], larger effects would be expected by a
subcutaneous electrodes decreases the LF/HF ratio of HRV, more chronic protocol and potentially longer durations of
suggesting increased parasympathetic tone [12]. Thus, the daily interventions.
stimulation of cutaneous afferent nerve fibers in the
anatomical location where OA-D is performed activates Another limitation of our study is the somewhat nar-
vagal tone. Therefore, it is possible that OA-D increases row focus on the parasympathetic nervous system via the
vagal tone by activation of cutaneous C1-C2 occipital vagus nerve. In this study, we did not consider potential
afferent nerve fibers rather than the treatment of somatic effects of the sympathetic nervous system. For example, in
dysfunction. If this was the case, a standardized applica- the OA-D group, we did not treat any somatic dysfunctions
tion of OA-D with a well-defined pressure applied for a in the upper thoracic spine to target sympathetic tone.
well-defined time period should result in consistent vagal Animal studies demonstrated that experimentally-induced
activation, whereas a clinical or therapeutic approach to damage of the sympathetic stellate ganglion lowers ven-
OA-D would result in a more variable vagal response. tricular rate in dogs with pacing-induced persistent atrial
Future studies may evaluate whether a standardized fibrillation [39, 40]. Thus, it may be interesting to conduct
application of OA-D utilizing an optimized pressure and future OMT studies that include balancing the sympathetic
timing is indeed more effective in activating vagal tone nervous system via treating somatic dysfunction in the
than a clinical approach that focuses on treating existing cervical and upper thoracic spine, clavicle, and ribs to also
somatic dysfunctions. In addition, it appears important to target the sympathetics.
investigate if there are relationships between the vagal
response to OA-D and the pressure applied or the duration Finally, we did not assess the study participants in
for which the pressure is applied. the OA-D group for potential somatic dysfunctions.
Knowing the degree of somatic dysfunction as it relates to
To the best of our knowledge, there are currently no the vagus nerve could have been useful for correlation
published studies on the effect of OMT on atrial fibrillation. analyses, investigating if the effect of OA-D on the
Our study does not change this, because it was conducted PQ-interval is largest in subjects with more severe
in generally healthy individuals in sinus rhythm. However, somatic dysfunction.
the finding of a prolongation of atrioventricular

358 Dalgleish et al.: OA-D and taVNS slow atrioventricular conduction velocity

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J Osteopath Med 2021; 121(4): 361–370

General Review Article

Mary Beth Babos, PharmD, Joseph D. Perry, BS, Sara A. Reed*, BS, Sandra Bugariu, BS,
Skyler Hill-Norby, BA, Mary Jewell Allen, DO, Tara K. Corwell, BS, Jade E. Funck, MS,
Kaiser F. Kabir, MS, Katherine A. Sullivan, MS, Amber L. Watson, BS and
K. Kelli Wethington, BSN

Animal-derived medications: cultural
considerations and available alternatives

https://doi.org/10.1515/jom-2020-0052 selection,” “medication,” “adherence,” “pharmaceutical
Received March 12, 2020; accepted October 20, 2020; preparations,” “religion and medicine,” “religion,” “an-
published online March 8, 2021 imal,” “dietary,” “porcine,” and “bovine.” Studies that
reported using surveys or questionnaires to examine pa-
Abstract tient, physician, or religious leader perspective on
animal-derived medications published in English be-
Context: Cultural competency is a cornerstone of patient- tween 1990 and 2020 were included. Review articles,
centered health care. Religious doctrines may define appro- opinion pieces, case reports, surveys of persons other
priate consumption or use of certain animals and forbid use than patients, religious leaders, or physicians, and
of others. Many medications contain ingredients that are studies published in languages other than English were
animal-derived; these medications may be unacceptable to excluded. Three authors independently reviewed articles
individual patients within the context of their religious be- to extract information pertaining to perspectives on
liefs and lifestyle choices. Knowledge of animal-derived animal-based medication ingredients.
medications as a component of cultural competency can Results: Eight studies meeting the described criteria were
facilitate a dialogue that shifts focus from the group to the found that queried beliefs or knowledge of patients, reli-
individual, away from cultural competency toward cultural gious leaders, or physicians regarding medications and
humility, and away from a paternalistic provider/patient medical products of biologic origin. Those studies are
dynamic toward one of partnership. described in full in this review.
Objectives: To explore how animal-derived drug compo- Conclusions: Knowledge of animal-derived ingredients
nents may impact medication selection and acceptability may help open conversations with patients around spiritual
from the perspective of patients, physicians, and religious history and cultural competency, particularly for those
leaders as evidenced by studies that explore the question patients belonging to religious sects with doctrines that
via survey or questionnaire. A secondary objective is to define appropriate use of human- or animal-derived prod-
use the context of animal-derived drug products as a ucts. Further formal study is needed to explore more fully
component of cultural competency to build a framework the extent to which religious beliefs may impact selection of
supporting the development of cultural humility. animal- or human-derived medications. Guidelines devel-
Methods: A systematic search was performed in the oped from this knowledge may aid in identifying individual
PubMed, CINAHL, Cochrane, and ProQuest databases patients with whom the discussion may be particularly
using combinations of the following terms: “medication relevant. More studies are needed to quantify and qualify
beliefs regarding animal-derived medication constituents.
*Corresponding author: Sara A. Reed, BS, c/o Mary Beth Babos,
Lincoln Memorial University – DeBusk College of Osteopathic Keywords: animal-derived medications; cultural compe-
Medicine, 6965 Cumberland Gap Parkway, Harrogate, TN 37752, USA, tency; religion; patient care.
E-mail: [email protected]
Mary Beth Babos, PharmD, Joseph D. Perry, BS, Sandra Bugariu, BS, Many physicians report difficulty in initiating conversa-
Skyler Hill-Norby, BA, Mary Jewell Allen, DO, Tara K. Corwell, BS, Jade tions about spirituality and religion with their patients
E. Funck, MS, Kaiser F. Kabir, MS, Katherine A. Sullivan, MS, Amber L. [1, 2]. Religious and spiritual beliefs are intimately inter-
Watson, BS and K. Kelli Wethington, BSN, Lincoln Memorial connected to health beliefs; spiritual concerns are cited as
University – DeBusk College of Osteopathic Medicine, Harrogate, important by nearly all hospitalized patients [1]. A survey of
TN, USA

Open Access. © 2020 Mary Beth Babos et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0
International License.

362 Babos et al.: Cultural considerations with animal-derived medications

230 patients with terminal cancer revealed that 88% cited exploring the state of the literature regarding acceptability
attendance to their religious belief by their provider to be at of biologically-derived medications, drawing attention to
least “somewhat” important [3]. The word “health” itself common biologic-derived medications and excipients, and
derives etymologically from the same root as “whole” and opening a discussion to promote the selection of pharma-
“holy” [3]; thus, the domain of spirituality is integral to the ceuticals in support of individual patient autonomy, self-
principles of patient-centered health care. Conducting a regulation, and religious or cultural beliefs.
“spiritual history” during clinical encounters can ease
initiation of this conversation to support integration of the As a competency, cultural competency assumes that a
individual patient’s religious, spiritual, or secular beliefs quantifiable set of cultural diversity-related skills can be
into the treatment plan [4]. It is critical to perform this learned. Limitations to this approach include the fluid
assessment in a sensitive manner, promoting a safe space nature of culture, “false competence” wherein the culture
where spiritual and religious matters can be discussed, is being defined from a perspective of privilege outside
addressed, and integrated [5]. the context of the culture itself, measurement errors, and
the ecologic fallacy that assumes all individuals conform
Spiritual history is defined as a “set of questions to the norms of the group [17, 18]. In contrast, cultural
designed to invite patients to share their religious or spir- humility is a continuous process of awareness that an
itual beliefs to help identify spiritual issues.” [6] The spir- individual patient’s cultural beliefs may impact health
itual history should be used to assess the patient’s beliefs behaviors. Like culture itself, cultural humility is a
that affect coping mechanisms, support systems, and any “changing, plastic process” [19] that involves continued
strong influential ideology that could impact medical self-evaluation for assumptions and bias, active listening
decision-making [2, 5]. Performance of the spiritual history to each patient as an individual, and continuous attain-
is not another checklist to complete, but rather a complex ment of knowledge [18, 20].
task that requires active listening on the part of the inter-
viewer to elicit the spiritual factors that impact patient As a systematic review focused on the impact of reli-
health beliefs and outcomes [2]. Many clinicians face dif- gious belief on medication selection related to animal-
ficulty addressing and assessing spiritual needs in practice derived drug ingredients, the primary objective of this
[2, 7]. Several tools have been developed to help practi- research was to provide quantified categorical information
tioners invite discussion of patient beliefs, including a to promote awareness of the importance of the issue. We
systematic review by Lucchetti et al. [7] and an expert panel update and expand upon earlier reports and editorials
discussion by Paal et al. [2] As with all aspects of reviewing [9–17] to focus on studies that investigate patient, religious
a patient’s history, queries should be respectful to the pa- leader, and physician-provider perspectives. We offer brief
tient and should avoid any judgmental questioning or synopses of beliefs in six major United States’ religious
spiritual persuasion [2, 7, 8]. sects to identify common beliefs that may impact patient
satisfaction with medication selection. We highlight com-
One aspect of patient cultural belief that may impact mon medications and ingredients that may be problematic,
medical care involves medicines and surgical products and we offer resources that may help prescribers identify
derived from animal and human sources [9–11]. A growing potentially problematic medication constituents and their
consensus is emerging among prescribers regarding the potential alternatives. We offer this information in the hope
need to inform patients who might object to animal-derived the reader uses the knowledge as a foundation from which
medications [12, 13], though prescribers are often unaware to engage individual patients in conversations that lead to
that medicines contain animal-derived ingredients [9]. the bidirectional flow of cultural knowledge necessary for
Several nations have published guidelines to address cultural humility-embedded practice.
pharmaceuticals of animal origin. The United Kingdom’s
first guidelines were published in 2004 [14] and Australia’s Methods
inaugural document, initially published in 2007, was
updated in 2019 [15]. In 2018, the American Medical Asso- Search strategy
ciation House of Delegates passed a resolution recom-
mending efforts to improve cultural awareness of animal- We followed the Preferred Reporting Items for Systematic Reviews
derived medication ingredients and encouraged the U.S. and Meta-Analysis (PRISMA) [21] guidelines for this systematic
Food and Drug Administration (FDA) to make information review, as illustrated in Figure 1. Electronic databases including
related to source of medication ingredients accessible [16]. PubMed, Cumulative Index to Nursing and Allied Health Literature
These recommended guidelines from the FDA are not yet (CINAHL), Cochrane, and ProQuest were searched systematically
available. In the interim, this paper aims to fill the gap,

Babos et al.: Cultural considerations with animal-derived medications 363

Figure 1: Preferred Reporting Items for
Systematic Reviews and Meta-Analyses
flowchart of study selection.

to identify articles published in English between 1990 and 2020 Study selection
that sought information from patients, religious leaders, or phy-
sicians via surveys or questionnaires related to the impact of reli- Articles identified in the preliminary database search were initially
gious beliefs or animal-related dietary habits on medication screened for relevance based on title and abstract where available.
selection. Review articles; opinion pieces; case reports; surveys of After elimination of duplicates, full-text articles were reviewed for
persons other than patients, religious leaders, or physicians; and presence of experimental or quasi-experimental design in the form of a
studies published in languages other than English were excluded. survey, questionnaire, or communication with predefined target
The searches were performed in July and August 2020 by four re- groups including physicians, patients, or religious leaders. Three re-
searchers (M.B.B., S.A.R., S.B., S.H.N.). References from full-text searchers (M.B.B., S.A.R., S.B.) reviewed the articles. Inclusion was
articles reviewed were mined to identify additional potential determined by consensus, and no differences in opinion required
studies for inclusion. Keywords and search strings used for resolution.
PubMed were as follows: “pharmaceutical preparations” (PubMed
Medical Subject Heading [MeSH]) AND “religion and medicine” Results
(MeSH); “porcine” AND “medication selection” AND “religion”;
“bovine” AND “medication selection” AND “religion”; “animal” Preliminary database searches yielded 443 articles. Mining
AND “medication selection” AND “religion”; “dietary” AND references to identify potentially useful articles yielded two
“medication selection” AND “religion.” Keywords and search additional studies. Of the 445 articles, 420 were deemed off-
strings used for both CINAHL and Cochrane were as follows: topic. After eliminating duplicates, 15 full-text copies of
“medication” AND “adherence” AND “religion”; “porcine” AND potentially relevant articles were obtained for further
“medication selection” AND “religion”; “bovine” AND “medica- scrutiny. Articles were included if they reported conducting
tion selection” AND “religion”; “animal” AND “medication selec- a survey or questionnaire of patients, religious leaders, or
tion” AND “religion.” Keywords and search strings used for physicians to ascertain perspectives on acceptability of
ProQuest were as follows: “medication adherence” AND “reli-
gion”; “porcine” AND “medication selection” AND “religion”;
“bovine” AND “medication selection” AND “religion”; “animal”
AND “medication selection” AND “religion.”

364 Babos et al.: Cultural considerations with animal-derived medications

animal-derived medications. Seven articles were excluded Salvation Army branch of Christianity, and Sikhism. Many
due to lack of data generated via survey, questionnaire, or religious leaders (77%; 10 of 13 surveyed) stressed the
other communication with target subjects. importance of patient consent when potentially prob-
lematic products are used. Leaders of the Greek Orthodox,
Data extraction Jewish, and Hindu faiths reported that all products were
acceptable. Human products were acceptable by
Four researchers (M.B.B., S.A.R., S.B., S.H.N.) extracted Buddhist, Roman Catholic, Salvation Army, Anglican,
data, summarized major findings, and synthesized over- and Quaker leaders if the donor provided consent, with
arching conclusions about acceptability of medications by the caveats that fetal material is unacceptable to Anglican
those surveyed in the studies, as depicted in Table 1. leaders and grafts from neonatal prepuce were unac-
ceptable to Quaker leaders. Islamic leaders would reject
Characteristics of selected studies porcine-derived products unless there were no other op-
tions. The Chinese Multicultural Society expressed
Risk of bias varied widely across studies. Several studies concern regarding bovine-derived products for Hindu and
solicited opinions from religious leaders without providing Buddhist members and porcine-derived products for
clear inclusion criteria for selection of subjects or selection Muslim members. Leaders of the Methodist Church
of religions. Studies were performed in Australia, several stressed that cruelty to animals would be unacceptable,
countries in continental Europe, the United Kingdom, and while Buddhist leaders qualified that animal products are
the United States. acceptable if the animal is not killed solely to obtain the
product. The investigators also detailed the knowledge
Findings of individual studies of 73 healthcare providers regarding ingredients of bio-
logic products to find that none knew the origin of all 11
In 2008, Easterbrook and Maddern [22] published a litera- products.
ture review of the impact that Hindu, Islamic, and Jewish
faiths may have on use of surgical supplies in Australia. Published in 2013, a study by Eriksson et al. [23]
The relative lack of information led them to seek further detailed the results of a validated seven-point questionnaire
information via unspecified means of communication with that sought the opinions of religious leaders in 26 European
an unspecified number of religious leaders. Jewish and countries. Results from individual sects were pooled to
Muslim leaders agreed that use of porcine products nor- summarize beliefs of six major religions: Buddhism,
mally prohibited by both religions is acceptable when Christianity, Hinduism, Islam, Judaism, and Sikhism. Ten
needed to protect life. The chairman of the Hindu Council religious leaders responded. The Sikh leader and the leader
of Australia indicated that bovine-derived products are of the Hindu Vaishnav sect objected to use of medication or
considered unacceptable. surgical dressing derived from animal sources, though the
objection would be waived in emergency situations or in
A 2005 study by Enoch et al. [12] aimed to discover routine treatment where no alternative exists. Muslim
views of religious leaders in the United Kingdom leaders rejected porcine-derived products, but waived the
regarding use of biologic-derived skin substitutes and objection lacking alternatives or in emergencies. Buddhist,
surgical dressings and to evaluate awareness of health- Christian (including Jehovah’s Witness), and Jewish leaders
care providers about potentially problematic products. did not reject any source of tissue or drug, except for blood-
A questionnaire regarding 11 biologic products was derived products in the case of Jehovah’s Witness.
completed by the 13 leaders of religions that encompass
75% of the UK population. Products included were Jenkins et al. [13] investigated acceptance of bovine,
derived from humans, pigs, and cows. All religious human, and porcine-derived surgical mesh in a report
leaders completed the survey, representing the Anglican published in 2010. The authors sought to survey leaders of
sect of Christianity, Buddhism, the Chinese Multicultural major United States religions, the American Vegan Society,
Society, Greek Orthodox Christians, Islam, the Jehovah’s and People for the Ethical Treatment of Animals (PETA).
Witness sect of Christianity, Judaism, Hinduism, the Similar to the findings of Eriksson et al. [23], neither the
Methodist sect of Christianity, the Quaker sect of Chris- Buddhist leader nor the leaders of various Christian sects
tianity, the Roman Catholic sect of Christianity, the objected to animal- or human-derived mesh, with the
caveat that many Buddhists of the Theravada sect and
Christians of the Seventh Day Adventist sect who practice
vegetarianism as part of their faith may individually reject
animal-derived products. The leader of the Jehovah’s

Babos et al.: Cultural considerations with animal-derived medications 365

Table : Summarized findings of included studies.

Study Methods Findings

Easterbrook and Maddern,  [] Communication with Jewish, Muslim, and Porcine products acceptable in Judaism.
Hindu leaders in Australia (n unspecified) Porcine products acceptable in Islam in life-or-death or
when no alternative.
Enoch et al.,  [] Questionnaire about  products to reli- Vaishnav sect of Hinduism objects to bovine-derived
gious leaders (n=) and healthcare pro- products.
viders (n=) Greek Orthodox, Jewish, and Hindu leaders found
bovine, human, and porcine products unconditionally
Eriksson et al.,  [] Questionnaire to clergy in  countries acceptable.
(n=) Methodist leaders stressed that cruelty to animals in
obtaining constituents is unacceptable.
Jenkins et al.,  [] Questionnaire to leaders of six US reli- Buddhist leaders accept animal products when the ani-
Koshy et al.,  [] gious and  non-religious groups mal is not killed solely to obtain the product.
(n unspecified) Buddhist, Roman Catholic, Salvation Army, Anglican,
and Quaker leaders accept human products with donor
Communication with national bodies for consent.
major religions in the UK regarding surgi- Islamic leaders would reject porcine-derived products
cal supplies (n unspecified) unless there were no other option.
Buddhists accept all animal and human products.
Mahdi et al.,  [] Survey of American Muslim physicians Hindu Vaishnav sect rejects porcine and bovine surgical
Sattar et al.,  [] (n=) implants.
Survey of US patients (n=) and physi- Sikh sect found bovine products problematic but
Vissamsetti et al.,  [] cians (n=) in a US Veteran’s Affairs circumstantially acceptable.
Center Sunni and Shiite reject porcine-derived medications but
circumstantially acceptable.
Questionnaire UK patients (n=) Christians, Jews, and Theravada Buddhist allow human-
and animal-derived products, though Jehovah’s Witness
forbid blood-derived products.
Hindu and Sikh leaders allow human-derived products if
the donor had given consent.
Christian, Islamic, and Jewish sect leaders reported
acceptance of all tissue types.
Buddhist leader reported that individual Buddhists may
reject animal products.
Hindu leader reported avoidance of animal-derived
tissue.
Most religious leaders report that life-or-death circum-
stances would override restrictions.
All religious leaders found human-derived products
acceptable.
Buddhist, Hindu, Jain, and Sikh reject bovine products
with circumstantial exception.
Buddhist, Hindu, Islamic, Jain, and Sikh object to porcine
products with circumstantial exception.
.% would recommend a porcine-based vaccination in
a scenario-based survey.
 of the patients surveyed adhered to faiths with beliefs
that define acceptability of animal products.
Of those, nine thought it important to be informed by
their physician of a medication containing a restricted
ingredient.
% (n=) of patients adherent to religions with di-
etary restrictions preferred non-animal-derived medica-
tion ingredients.

366 Babos et al.: Cultural considerations with animal-derived medications

Witness sect emphasized that adherents to this faith would patients would not routinely take any oral medication
reject blood-derived products. Hindu leaders reported that containing an animal product, though 100 of the 176
most adherents would reject animal-products, and their (56.8%) would do so if no alternative was available. The
belief in cremation of human remains may prohibit use of authors found that the number of patients stating prefer-
cadaver parts. Islamic leadership indicated no prohibitions ence for vegetarian medications was double that expected
for bovine, porcine, or human products in surgery, though based upon community religious demographics.
the authors recommend that many Muslims would prefer
non-porcine products. Leadership in the PETA group could Discussion
not endorse any practice that harmed animals, though they
strongly advocated for human-derived products that are Major U.S. religions associated with beliefs
ethically obtained. that may impact medication selection

In the UK, a surgical group contacted leaders of major Nearly 5.5% of the United States’ 330 million citizens
religions after a patient objection to an animal-derived identify with six major religious sects with teachings that
product in surgery highlighted the need for informed may impact medication selection: Judaism, Islam, Bud-
consent [24]. The authors stated neither their methodology dhism, Hinduism, and the Jehovah’s Witness and Seventh
nor the number of participants surveyed. They reported Day Adventist sects of Christianity [12, 28]. While there are
that Buddhist, Christian, Hindu, Islamic, Jain, and Jewish general lifestyle guidelines within each of these religions,
leaders all found human-derived surgical products followers’ beliefs are not homogenous; therefore, the
acceptable where donor consent has been obtained. All “spiritual history” is essential to identify the convictions
leaders reported that objections may be waived in life- and desires of each individual patient in a cultural
saving circumstances or where no alternates are available. humility-based approach. Additionally, in the context of
Buddhist, Hindu, Jain, and Sikh leaders reported that medical ethics and informed consent, physicians must be
routine use of bovine and porcine surgical products would equipped to provide patients with alternative compliant
be unacceptable. Christian and Jewish leaders reported therapies [11, 26]. Where uncertainty exists, spiritual or
acceptability of both bovine and porcine products. religious leaders may offer guidance in interpretation of
sacred texts as it applies to patient care [13, 29, 30]. Leaders
A scenario-based survey of American Muslim physi- of many faiths waive restrictions during emergency situa-
cians was published by Mahdi et al. in 2016 [25]. The scope tions where there are no viable alternatives [23]. Table 2
of this study covered ethically controversial medical pro- summarizes religious views that may more commonly
cedures, including use of a porcine-derived vaccine. Of 244 impact medication selection for common religious sects in
respondents, 186 (76.2%) would recommend the porcine- the United States.
derived vaccine presented in the scenario.
Potentially problematic drugs and drug
A survey of 100 patients and 106 physicians at the products
Veterans Affairs Medical Center in Omaha, Nebraska,
focused on awareness of animal-derived ingredients and Both active ingredients and inert excipients of pharma-
perspective on need for informed consent from patients ceuticals may contain animal-derived ingredients. Table 3
[26]. Thirteen of the studied patients belonged to faiths with lists the origins of common products available in the
dietary restrictions. Of these 13 patients, 9 (69.2%) were not United States that are directly derived from animals. In the
aware that medications might contain prohibited beef or United States, drug companies are not required to report
pork ingredients, 9 (69.2%) thought it important to be the origins of excipients. This represents a major limitation
informed before a medication containing pork or beef was to meaningful discussion with patients who are adherent to
prescribed, and 6 (46.2%) would be willing to pay more for avoidance of specific animal sources.
an alternate product that did not contain prohibited in-
gredients. Of the physicians surveyed, only 34 (32%) were As seen in Table 3, all heparinoids except the penta-
aware that medications might contain ingredients that saccharide fondaparinux are porcine-derived and thus
were prohibited by patients’ religions, 75 (70%) thought it may be problematic for adherents of Islam, Judaism, and
important to inform patients when such medications were those who practice vegetarianism and veganism. The
prescribed, while only 5 (4%) reported doing so.

A patient questionnaire found that 200 of 500 patients
surveyed in a UK urology practice avoided animal products
[27]. Of these 200 patients, 176 (88%) declared a preference
for vegetarian-based oral medications; 150 (85.2%) of these

Babos et al.: Cultural considerations with animal-derived medications 367

Table : Common U.S. religious sects with relevant restrictions.

Religion [] % of U.S. population Restrictions that may impact medication selection
Buddhism .%
Christian sects: Vegetarianism and veganism are common.
.%
Jehovah’s Witness .% Blood and blood products are problematic.
Seventh Day Adventism .% Vegetarianism is common.
Hinduism .% Vegetarianism is common. Bovine products are generally avoided.
Islam Vegetarianism is common. Haram (forbidden) include alcohol, animal-derived
.% enzymes, porcine products, meat from carnivores, and L-cysteine derived
Judaism from human hair.
Porcine products, products containing both meat and milk, and products from fish
that lack either fins or scales are generally avoided.

injectable direct thrombin inhibitors bivalirudin and or from bovine, piscine, or porcine skin [11, 30]. Demand for
argatroban are animal-free. animal-free products has increased availability of vege-
tarian capsules made with hypermellose [32]. Lactose is a
In the category of hormones, it is fortunate that insulin- common excipient in tablets, capsules, dry-powder in-
derived from modern recombinant DNA technology is halers, and injections; it has been traditionally derived
animal-free. Unfortunately, there are no truly animal-free from milk via extraction using bovine rennet. Some man-
oral thyroid hormone replacement products due to excip- ufacturers use a non-rennet process, but the origin of the
ients used in the tablet formations. Levothyroxine sodium sugar is still bovine milk, which may still be problematic
lyophilized powder is animal-free but requires intravenous for some [11]. Stearic acid and derivatives are often gener-
administration. ated from rendered bovine, porcine, or ovine fats, though
plant-sourced stearate is sometimes used. Unfortunately,
Immunoglobulin antitoxins for Crotalidae and Micrurus the source of stearate is not indicated on most labels [11].
envenomation are ovine and equine sourced, respectively; Other common problematic ingredients include albumin,
there are no animal-free options for these critical life-saving which may be either human or bovine in origin; insect-
medications. Similarly, digoxin immune fab is produced in derived carmine, cochineal, and shellac; bovine-derived
sheep. Most monoclonal antibodies used in medicine are casein; bovine or ovine deoxycholate; piscine-derived
derived through recombinant gene technology. Nonethe- protamine; and tallow, which may be bovine, ovine, or
less, they may be problematic due to use of animal cell lines porcine in origin [9–11].
for production (e.g., trastuzumab [Herceptin®] in Chinese
hamster ovary cells) and due to the presence of other animal Limitations
proteins introduced during production.
Many of the existing studies were based upon unstruc-
Vaccine production often incorporates many animal- tured communications rather than validated surveys
derived products. Cell lines for production, excipients, and and often focused on surgical products rather than sys-
nutritional supplements for cell culture are often problematic temically ingested medications. Additionally, very few
including bovine-derived trypsin, human or bovine albumin, investigations have been performed to explore over-
and use of aborted fetal cell lines. Due to the health- arching preferences and beliefs in the United States; the
preserving nature of immunization, religious scholars often domain of provider awareness in the U.S. remains largely
waive prohibitions for vaccines [11]. Such concerns regarding unexplored. Significant weaknesses of this review include
the halal status of the SARS-CoV-2 vaccine have made recent a large heterogeneity in methodologies, the small number
headlines. A media investigation revealed that Pfizer’s and limited variety of participants targeted for interview,
SARS-CoV-2 vaccine is sourced from Halal products, with and the variable foci of the queries. The acceptability of
lipid components derived from chicken egg [32]. The Vatican animal- or human-derived products is an individual pa-
recently announced that COVID-19 vaccines are morally tient decision. The scope of this study was limited to the
acceptable even if aborted fetal cell lines are used in their quantifiable domain of cultural competency; by its na-
research and production process [33]. ture, a systematic scoping review can neither inform of

Many inert excipients used in dosing formulations are
potentially problematic. Capsule formulations commonly
contain gelatin, which is a general term for a mixture of
proteins obtained via hydrolysis of bovine or porcine bone,

368 Babos et al.: Cultural considerations with animal-derived medications

Table : List of potentially problematic medications by class and potential alternatives [, , ].

Animal-derived product* Animal-free product*

Heparinoids Fondaparinux (Arixtra®)
Unfractionated heparin, dalteparin (Fragmin®),
enoxaparin (Lovenox®) (porcine) Estradiol topical gel, vaginal ring
None
Hormones Levothyroxine injection, levothyroxine tablets contain stearate,
lactose, or gelatin
Conjugated estrogens (equine) Recombinant insulins
Corticotropin (Acthar®) (porcine) None
Dessicated thyroid (Armour Thyroid®) (porcine)
None
Non-human insulins (various sources) None
None
Pancreatic enzymes (various sources)
Fospropofol (Lusedra®)
Immunoglobulins None
Crotalidae antivenin (CroFab®) (ovine)
Digoxin immune globulin (Digibind®) (ovine) None

Micrurus fulvius antivenom (equine) DTaP (Infanrix®), DTaP-IPV (Kinrix®), DTaP-HepB-IPV (Pediarix®)
Lipid emulsion-containing medications Hib (ActHIB®, PediavxHIB®)
Propofol (Diprivan®) (egg) None

Lipid emulsion (egg) None
Engerix-B®, Recombivax®
Surfactant None
Poractant alpha (Curosurf®) (porcine); calfactant (Infasurf®), None
beractant (Survata®) (bovine)
None
Vaccines
DTaP-IPV (Quadracel®), DTaP-IPV/Hib (Pentacel®) (Bovine); None
Hib (Hiberix®) (lactose)
Rotarix® – contains porcine circovirus type  and  DNA
Influenza vaccines (most contain egg) None
Flublok® (insect)
Flucelvax® (canine)
Hepatitis A (Havrix®) (aborted human fetal cell line), Vaqta® (bovine)
Hepatitis B (Heplisav-B®) (bovine or ovine)
Hep A/Hep B (Twinrix®) (aborted human fetal cell line)
Measles, mumps, rubella vaccine (MMRII®)

(bovine, gelatin – unspecified source)
Measles, mumps, rubella, varicella (ProQuad®)

(aborted human fetal cell line, bovine)
Rabies (Imovax®) (Human albumin); (RabAvert®)

(human albumin, bovine, chicken protein)
Rotavirus vaccine (RotaTeq®) (bovine)
Varicella (Varivax®, Zostavax®) (aborted human fetal cell line, bovine)
(Shingrix®) (cholesterol, host cell proteins – source unspecified)

*Listing of a brand is not an endorsement, but rather offers an animal-free option at the time this article was written. Product composition may
change. Please see body of text for resources to make certain products are animal-free.

individual patient preference nor help individual practi- description that lists ingredients. Different manufacturers
tioners develop the self-awareness and active listening may use different excipients in their product, so the
skills needed for cultural humility. manufacturer-specific product insert must be consulted.
The United States Library of Medicine [34] hosts a search-
Further drug ingredient-related information able online library of medication labels online.

While not specific to products available in the United Conclusions
States, the Australian Queensland Health Guidelines [15]
are comprehensive and are available online. The CDC Pink Development of cultural humility is an ongoing process of
Book [31] lists vaccine excipients and also may be accessed awareness that is integral to patient-centered care. Cultural
online. Drug package inserts list individual ingredients competency provides a measurable but generic basis of
and Section 13 of the official insert offers the product

Babos et al.: Cultural considerations with animal-derived medications 369

knowledge from which this awareness can grow. Taking a 8. Koenig HG. STUDENTJAMA. Taking a spiritual history. J Am Med
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J Osteopath Med 2021; 121(4): 371–376

Medical Education Brief Report

Jared Dubey*, DO, Sarah James, DO and Larissa Zakletskaia, MA

Osteopathic manipulative treatment for allopathic
physicians: piloting a longitudinal curriculum

https://doi.org/10.1515/jom-2020-0038 to obtain background information and assess participants’
Received March 11, 2020; accepted August 10, 2020; prior OMT exposure, among other things. Nine months after
published online February 15, 2021 the course ended, a corresponding postcourse survey was
distributed. Pre- and postcourse surveys were individually
Abstract matched to improve statistical analysis, using unique iden-
tifiers. Also, following each laboratory, a postlaboratory
Context: Under the Accreditation for Graduate Medical Ed- survey was collected about the participant’s experience for
ucation (ACGME) single accreditation system, there is likely that lecture and for laboratory-specific quality improvement
to be increasing interest and opportunity for teaching osteo- purposes. Two years after course completion, graduates
pathic manipulative treatment (OMT) to allopathic residents were reached via phone or email for informal interviews to
and residency faculty. When learning OMT, allopathic phy- assess the perceived long-term impact from the elective.
sicians (MDs) have distinct needs compared with osteopathic Results: Eleven MDs from a total potential pool of 26 res-
medical students. For example, MDs already have a foun- idents and approximately 120 attending physicians
dation in anatomy and medical vocabulary, but incorpo- enrolled in the course; eight (72.7%) completed all modules
rating an osteopathic approach to patient care may require a and pre- and postcourse evaluations. Participants reported
paradigm shift. Thus, a unique approach to osteopathic ed- statistically significant gains in attitudes and confidence
ucation for MDs in residency programs with osteopathic regarding OMT (“knowledgeable regarding OMT princi-
recognition (OR) is needed. ples”: precourse mean, 2.50 [0.76], vs. postcourse mean,
Objectives: To create a longitudinal OMT elective for 3.37 [0.52]; p=0.021; “know how to treat using OMT”: pre-
allopathic residents and residency faculty and assess its course mean, 2.25 [1.39], vs. postcourse mean, 3.12 [1.25];
impact on attitudes and confidence regarding osteopathic p=0.041). Several participants (five; 62.5%) had completed
principles and treatment. prior OMT training. There was an increase, albeit nonsig-
Methods: Drawing from standard texts used during nificant, in the use of OMT, with more providers using OMT
preclinical osteopathic education, a blended online and (precourse mean, five, vs. postcourse mean, six; p=0.171),
in-person laboratory modular curriculum for the OMT elec- and providers using OMT more often (precourse OMT use
tive course was developed by osteopathic residents and monthly or more often, three, vs. postcourse OMT use
faculty within the Department of Family Medicine and monthly or more often, six; p=0.131).
Community Health at the University of Wisconsin in Conclusions: Implementing a longitudinal elective curricu-
Madison. The modalities of muscle energy, counterstrain, lum is a feasible way to improve attitudes and confidence in
myofascial release, and soft tissue were included; the OMT for MDs involved in a family medicine residency.
curriculum also reviewed autonomic physiology, somato- Whether our elective leads to competency in OMT for allo-
visceral, and viscerosomatic reflexes. A quality improvement pathic residents and faculty remains to be formally evaluated.
study of the course was conducted via pre- and postcourse Our pilot established the feasibility and led to a revision of our
surveys to assess its impact on perceptions and confidence curriculum; the elective continues to occur yearly. Future
regarding the theory and practice, referral, and use of OMT. analyses will focus on competency assessment.
A precourse survey was distributed before the first module

*Corresponding author: Jared Dubey, DO, Northeast Family Medical Keywords: allopathic physician; curriculum; GME; medical
Center, 3209 Dryden Dr, Madison, WI 53704-3015, USA, education; osteopathic manipulative treatment; osteopathic
E-mail: [email protected]. https://orcid.org/0000- physician
0002-8294-3832
Sarah James, DO and Larissa Zakletskaia, MA, Department of Family Osteopathic manipulative treatment (OMT) has many
Medicine and Community Health, Scholl of Medicine and Public applications for patient care, and a growing body of
Health, University of Wisconsin, Madison, WI, USA evidence supports its use. For example, OMT improves

Open Access. © 2020 Jared Dubey et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0
International License.

372 Dubey et al.: Piloting a longitudinal curriculum

pain scores and reduces analgesic use in patients with Methods
chronic and pregnancy-related low back pain [1, 2], and
studies have shown that hospitalized patients receiving Curriculum design
OMT as adjunctive care for pneumonia [3] and in the
postoperative period after abdominal surgery [4] have Drawing from standard texts used during preclinical osteopathic
better outcomes. Additionally, preliminary evidence has education, specifically Foundations of Osteopathic Medicine (FOM) [12],
suggested that OMT helps patients with conditions such a blended online and in-person laboratory modular curriculum was
as recurrent otitis media [5], neck pain [6], and irritable developed by osteopathic residents and faculty within the Department
bowel syndrome [7]. Due to the growing evidence base for of Family Medicine and Community Health at the University of Wis-
OMT coupled with the recently-completed transition to consin in Madison during the summer of 2016. The modalities of muscle
the Accreditation Council for Graduate Medical Education energy, counterstrain, myofascial release, and soft tissue were included.
(ACGME) single accreditation system, we anticipate In addition to musculoskeletal applications of OMT, the curriculum
increased interest in OMT education among allopathic reviewed autonomic physiology, somatovisceral, and viscerosomatic
physicians (MDs). reflexes. Each module included readings, prerecorded online lectures,
in-person laboratory sessions, and completion of practice logs. Read-
The University of Wisconsin family medicine residency ings were assigned from FOM [12] and the Basic Musculoskeletal
program was among the first of 18 programs to attain Manipulation Skills – The 15 Minute Office Encounter (BMMS) [13].
osteopathic recognition (OR) through the ACGME in 2015. Maintaining a high DO-to-MD ratio of 1:4 or greater during laboratory
Today, 234 programs across 21 specialties have achieved sessions ensured adequate feedback and guidance for learners. Clinical
OR [8]. One outcome of the move to a single graduate preceptorship with osteopathic faculty practicing OMT in one or more of
medical education (GME) accreditation system was that our residency continuity clinics for additional experience was also
programs with OR may enroll allopathic residents into provided. The total estimated time for course completion, including
osteopathically-designated positions [9]. While program- prelaboratory preparation, laboratory attendance, and practice logs was
specific requirements for residents in these programs may 70 hours. Original curriculum overview, including modular organiza-
include background training in OMT, there are currently tion and a sample resident schedule, is shown in Table 1.
no ACGME-mandated prerequisites, and a knowledge
and skill gap is still likely between allopathic residents Participants and settings
and their osteopathic counterparts as it pertains to OMT
tenets and practices. Furthermore, literature shows that Beginning in July 2016, enrollment in the elective was initially open
allopathic faculty do not feel confident in their ability to to only senior family medicine residents (R2 and R3 years) at the
support education of the osteopathic learner [10]. We University of Wisconsin School of Medicine and Public Health in
suspect that improving allopathic faculty comfort with good academic standing, a total potential pool of 26 residents. The
OMT and providing a structured pathway through which course was advertised via email and word of mouth. Due to low
allopathic residents in OR positions can learn OMT will participation numbers (five residents elected to participate), in
promote and encourage the practice of OMT amongst August of 2016, attending physicians within our department were
all residents. Thus, the development of an osteopathic also invited to take the course. Resident and attending physicians
curriculum that targets MDs is paramount to integrating were enrolled from September 2016 through June 2017.
OMT into residency training in the single GME accredita-
tion landscape. Study design

Much attention has been devoted to OMT training We conducted a quality improvement project on our new curriculum
for osteopathic residents [9–11]. While limited OMT courses to assess its impact on perceptions and confidence regarding the
are available nationally for MDs, no established longitu- theory and practice, referral, and use of OMT. The Institutional Review
dinal curriculum currently exists for allopathic residents to Board at the University of Wisconsin in Madison determined this
learn OMT during residency. To meet interest in our project to be exempt. A printed precourse survey (Supplementary
department and the need for osteopathic curriculum for material) was distributed by hand before the first module in September
MDs in residency programs, we designed a longitudinal of 2016 to obtain background information and assess participants’
elective curriculum in OMT and evaluated its effect on prior OMT exposure, satisfaction with options for managing low back
participants’ attitudes, knowledge, and practice of OMT. pain and headaches, use of OMT, referral for OMT, and confidence
regarding principles and practice of OMT. Completion of the survey
was required prior to the beginning of the first lab session. Nine
months after the course ended, in March 2018, a corresponding digital

Dubey et al.: Piloting a longitudinal curriculum 373

Table : Curriculum overview (a) and sample schedule (b) for a senior resident completing elective in two years.a

Module Didactic content Laboratory

(a) Curriculum overview of elective osteopathic course

Introduction History, definitions, principles, neuroanatomy, introduction to Layer palpation, screening structural exam, thoracolumbar

spinal mechanics and structural diagnosis, introduction to ME, kneading and stretching, selected CS points, ME for

CS, ST, MFR hamstrings

Lower Functional anatomy of ankle, knee, and hips, ME assessment of Muscle energy diagnosis and treament of talocrural joint,

Extremity talocrural joint, fibular head, commomn CS points in the LE fibular head, quadricep, and psoas; CS for hamstring tender

points, MFR for interosseous membrane

Pelvis Functional anatomy of pelvis, ME model diagnosis of innomi- ME diagnosis and treatment of innominate shears and rota-

nate shears and rotations tions, CS for anterior pelvic tenderpoints

Sacrum Functional anatomy of the scarum, ME model diagnosis of the ME diagnosis and treatment of scarum, MFR for sacroiliac and

scarum lumosacral joints, posterior pelvic CS tender points

Lumbar Functional anatomy of the lumbar spine and segmetal diagnosis ME diagnosis and treatment of lumbar spine, paraspinal

kneading and stretching, anterior lumbar CS tender points

Thoracic Functional anatomy of the thoracic spine and segmental ME diagnosis and treatment of thoracic spine, paraspinal ST,

diagnosis posterior thoracic CS tenderpoints

Ribs Functional anatomy of the rib cage, diagnosis of inhalationa and ME diagnosis and treatment of inhalation and exhalation ribs,

exhalation ribs MFR for diaphgram

Cervical Functional anatomy of the cervical spine and segmental ME diagnosis and treatment of cervical spine, paraspinal ST,

diagnosis MFR for thoracic inlet

(b) Sample schedule for senior resident

Year  Introductiona Lower extremity Sacrum Thoracic spine Ribs Review

Year  Introduction Pelvis Lumbar spine Cervical spine

aIntroduction module required in year one. CS, counterstrain; ME, muscle energy; MFR, myofascial release; ST, soft tissue techniques.

postcourse survey (Supplementary material) developed via Qualtrics medicine and rehabilitation. Eight of 11 physicians (72.7%)
(SAP SE) was distributed online via email. One reminder was sent via completed the course as well as both pre- and postcourse
email after two weeks. Pre- and postcourse surveys were individually surveys and were included in our analysis. A majority of
matched to improve statistical analysis, using unique identifiers with the cohort had some amount of prior instruction in OMT
the combination of the last three digits of phone numbers and the first (five [62.5%]), previously referred for OMT (six [75%]), or
two letters of their mothers’ maiden names. Also, following each used OMT in their own practices (five [62.5%]; Table 2).
laboratory, a digital postlaboratory survey (Qualtrics; SAP SE) was
distributed via email to gather feedback regarding the participant’s Table : Participant (n=) background characteristics.
experience for that module and for laboratory-specific quality
improvement purposes. Lastly, two years after course completion, in Sex n (%)
June 2019, graduates were reached via phone or email for informal Female
interviews to assess the perceived long-term impact from the elective. Male  (.%)
 (.%)
Data analysis Level of training
Attending  (.%)
We calculated summary statistics and compared responses among Resident  (.%)
respondents from pre- and postcourse surveys using a χ 2 test and
paired t test. Prior instruction in OMT  (.%)
None  (.%)
Results – hours  (.%)
– hours  (.%)
From a total possible participant pool of 26 residents and + hours
approximately 120 attending physicians, we enrolled 11 MD  (%)
physicians in the study, including five residents (45.5%) Ever referred for OMT  (%)
and six attending physicians (54.5%). All residents and Yes
five attending physicians were trained in family medicine, No  (.%)
and one attending physician was trained in physical  (.%)
Currently treat patients with OMT
Yes
No

OMT, osteopathic manipulative treatment.

374 Dubey et al.: Piloting a longitudinal curriculum

Table : Pre- and postcourse OMT satisfaction and knowledge Table : Pre-post OMT referral and treatment (n=).
(n=).a

Frequency of OMT referral Pretest, n (%) Posttest, n (%) p-valuea

Precourse, Postcourse, p-valueb Never  (%)  (.%) .
mean (SD) mean (SD) Yearly   .
Monthly .
I am satisfied with options . (.) . (.) . Weekly  (%)  (.%) .
Daily  (%)  (%) .
I currently have for treating Treat patients with OMT 
Never 
low back pain. Yearly
Monthly  (.%)
I am satisfied with options . (.) . (.) . Weekly  (%)
Daily 
I currently have for treating  (%) .
 (.%)  .
headaches. . (.) . (.) .c  .
I am knowledgeable  (%) .
 (%) .
regarding the principles that  (%)

guide osteopathic diagnosis

and treatment. . (.) . (.) .c ap-value based on χ test. OMT, osteopathic manipulative medicine.
I know the indications for

treating a patient with OMT.

I can find areas or regions of . (.) . (.) . mean, 1.75, vs. postcourse mean, 3.12; p=0.014), and OMT
application (precourse mean, 2.25, vs. postcourse mean,
somatic dysfunction. . (.) . (.) .c 3.12; p=0.041; Table 3). There was no statistically significant
I can make specific osteo- effect on satisfaction for options to manage low back pain
(precourse mean, 2.88, vs. postcourse mean, 3.25; p=0.351)
pathic diagnoses in regions or headaches (precourse mean, 3.12, vs. postcourse mean,
3.50; p=0.080). There was no statistically significant change
of somatic dysfunction. . (.) . (.) .c in frequency of OMT referral or use of OMT (precourse OMT
I know how to treat using referral monthly or more often, six, vs. postcourse , seven;
p=0.522; precourse OMT use monthly or more often, three,
OMT. vs. postcourse OMT use monthly or more often, six; p=0.131),
though there was a trend toward more frequent referral and
I am familiar with the mechanisms of treatment for the following use of OMT (precourse OMT use monthly or more often,
three, vs. postcourse OMT use monthly or more often, six;
modalities: . (.) . (.) .c p=0.131; Table 4). The modality of muscle energy saw the
Soft tissue . (.) . (.) .d largest statistically significant gains in participant confi-
Muscle energy . (.) . (.) .c dence regarding theory (precourse mean, 2.62, vs. post-
Counterstrain . (.) . (.) .c course mean, 3.75; p=0.007), application (precourse mean,
Myofascial release 2.12, vs. postcourse mean, 3.25; p=0.002), indications
(precourse mean, 2.37, vs. postcourse mean, 3.62; p=0.011),
I am confident treating somatic dysfunction using the following and contraindications (precourse mean, 2.37, vs. postcourse
mean, 3.25; p=0.006; Table 3). At two-year postcourse
modalities: completion follow-up, four participants (two former resi-
dents without prior OMT exposure and two attendings with
Soft tissue . (.) . (.) . prior OMT training), were using OMT in their practices on at
Muscle energy . (.) . (.) .d least a weekly basis.
Counterstrain . (.) . (.) .c
Myofascial release . (.) . (.) .d Statistical analysis of postlaboratory surveys was not
performed; however, informal review of these surveys
I am familiar with the indications for the following modalities: suggested that participants favored prerecorded online
lectures over assigned readings and that in-person labo-
Soft tissue . (.) . (.) . ratory sessions were highly valued. The breadth of topics
Muscle energy . (.) . (.) .c within each laboratory was sometimes considered too
Counterstrain . (.) . (.) .c expansive, with suggestions to reduce topics and focus on
Myofascial release . (.) . (.) .c more repetition and review.

I am familiar with the contraindications for the following modalities:

Soft tissue . (.) . (.) .c

Muscle energy . (.) . (.) .d

Counterstrain . (.) . (.) .c

Myofascial release . (.) . (.) .c

aMeasured with -point Likert scale; =not at all; =somewhat;
=completely. bp-value is based on paired t-test. cp<.. dp<..

On a five point Likert scale, participants showed sta-
tistically significant increases in confidence regarding
osteopathic principles after the course (precourse mean,
2.50, vs. postcourse mean, 3.37; p=0.021), indications for
OMT (precourse mean, 2.75, vs. postcourse mean, 3.5;
p=0.020), diagnosis of somatic dysfunction (precourse

Dubey et al.: Piloting a longitudinal curriculum 375

Discussion Our quality improvement study was not designed to
assess skill acquisition. However, the authors’ observations
The inspiration for this project was borne out of interactions of participants’ skill development, in combination with
between DO and MD residents in our family medicine resi- informal interviews, suggested that attaining competency
dency program. Several MD residents were keenly interested across the broad range of OMT modalities included in our
in OMT and desired to learn about and incorporate this curriculum demands a significant amount of study and
useful modality into their practices. Fueled by this interest practice that is likely beyond the 70 hours we estimated to
amongst our MD colleagues, our passion for osteopathic complete the course. These observations support the current
education, and the need for innovative OMT pedagogy in the standard that osteopathic medical students receive 200 to
single GME accreditation system environment, we set out to 300 hours of OMT training during their preclinical years in
design and implement a structured curriculum with regular medical school [14]. Additionally, skill development was
hands-on laboratory sessions that would constitute a robust highly variable among participants, consistent with differ-
OMT training for allopathic residents and faculty. ences in the time invested and previous OMT instruction.

We recognized the need for a distinct approach to oste- The question of competency is a crucial one when
opathic education in the context of GME. While DO students assessing a training curriculum. Two elements prevented
learn anatomy, physiology, and pathology at pace with their us from answering the competency question. First, formal
introduction to OMT, MDs who begin osteopathic training do objective assessments, including practical and written
so with preexisting knowledge in these fields. Furthermore, examinations, were not included. While initial brain-
doctor–patient interaction and comfort with therapeutic storming for this project had the goal of competency
touch may already come naturally to MDs, especially those assessment, we quickly realized that real-time curriculum
who are beyond their initial training. These distinctions pre- design and the logistics of its delivery taxed our resources.
sent certain advantages and disadvantages for MDs under- Second, we conceived of an elective primarily for OMT
taking osteopathic training. While MDs will have a strong naïve residents, but our pilot cohort comprised a majority
background in anatomy and vocabulary, thinking about attending physicians, several of whom had prior OMT
medicine and patient care osteopathically may require a training. Therefore, we chose to focus on feasibility, quality
paradigm shift, which can present its own obstacles. We built improvement, and impact on participants’ perceptions.
our curriculum with these considerations in mind, choosing
to review anatomy in prerecorded lectures and incorporating We continue to offer the elective yearly. To improve skill
case examples for each unit that integrated osteopathic acquisition for subsequent cohorts, we narrowed the cur-
reasoning, diagnosis, and treatment into the decision-making riculum’s scope by eliminating the modality of myofascial
model of a practicing clinician. release, which allowed for more repetition and review of
other topics. Additionally, we shifted reading assignments
Our course’s strengths included modular organization from FOM to Osteopathic Techniques: The Learner’s Guide
and a robust prelaboratory curriculum, which allowed par- [15], which our learners found more approachable. Begin-
ticipants to maximize hands-on time during in-person ses- ning with the cohort enrolled in 2018, we successfully
sions and provided flexibility for integrating the course into included postcourse written and skills assessments. Anal-
residents’ existing schedules. Depending on the program- ysis and reporting on these groups is forthcoming.
specific OR eligibility requirements, this course could
educate faculty, prepare an allopathic resident to enter an If the ACGME single-accreditation system is any indi-
OR position, or train MD residents in OR positions during cator, the separation between allopathic and osteopathic
residency. However, while gains in attitudes and confidence training will continue to narrow. As osteopathic physi-
regarding OMT were significant, participant competency to cians, we share a sense of pride and protectiveness for the
practice OMT was not evaluated. Additionally, prior OMT tenets of osteopathic philosophy and our distinct approach
training among participants limits the extent to which we to patient-centered care and hands-on healing. By sharing
can extrapolate the impact the curriculum might have on a the art and practice of OMT, our osteopathic principles and
group of physicians without previous OMT exposure. It is practices will be better protected because respect and
possible that an OMT naïve cohort may not experience the appreciation grow out of direct experience. We suspect this
positive impact we saw. On the other hand, it is also possible positive regard will lead to increased referral rates for OMT
that an OMT naïve cohort would experience an even greater and increased use of OMT. However, without inclusive
impact from the curriculum, since all the material would be OMT education in residency programs with OR, it is the
an opportunity for new knowledge and skill acquisition. authors’ opinion that we run the risk of cultivating
resentment or dismissal towards OMT. As such, curricula