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CHAPTER TWO

OSTEOPATHIC RESEARCH – EVIDENCE BASED

OSTEOPATHIC MANIPULATIVE MEDICINE

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distributed without the express permission of the

NMM/OMM Department at WUHS/COMP.



1Osteopathic Research

IN THIS CHAPTER

Introduction to osteopathic research

Definitions of osteopathic research

History of research inquiries into the nature of somatic dysfunction

Comparative clinical outcomes of osteopathic manipulative treatment (OMT)

Randomized clinical trials of OMT

Challenges to osteopathic research

Where to find mentors for research in OMT

Databases for osteopathic research articles

LEARNING OBJECTIVES

After mastering the information in this chapter, the student will be able to:

Define osteopathic research using the AOA Bureau of Research definition;

Recognize the main contributions to OMM research by: Louisa Burns, DO; J.

Stedman Denslow, DO; Irvin M. Korr, PhD; and William L. Johnston, DO;

Describe the results of DO vs. MD care studies from the 20th Century;

Recite the results of randomized clinical trials of OMT presented in this chapter;

Recognize the challenges of OMM research;

Find a mentor for OMT research; and

Locate research articles in osteopathic databases.




INTRODUCTION

Unique “osteopathic” research has played only a small role in the growth and development of

the osteopathic profession and its institutions. However, since 2000, millions of dollars have

been infused into research endeavors that evaluate the distinctiveness of osteopathic practices, of

which osteopathic manipulative treatment (OMT) is the most recognizable characteristic. The

Osteopathic Research Center (ORC) in Texas at the University of North Texas Health Science

Center was created and has conducted many types of research in osteopathic manipulative

medicine (OMM) as well as basic science studies investigating the mechanisms of OMT effects.

The A.T. Still Research Institute in Kirksville, MO has also increased its efforts in osteopathic

manipulative medicine research and has partnered with the ORC on multi-site OMT clinical

trials. The American Osteopathic Association (AOA) has also increased its research funding and

promotes research endeavors investigating OMT and its mechanisms of action. This chapter will

review the results of some of the landmark osteopathic research studies as well as some of the

recent research endeavors that have had a significant impact on practice, education or research.

It is important to first clarify the definition of osteopathic research and realize that there are

several. The one that is most relevant to those of us involved in osteopathic research and

education at osteopathic institutions is the one used by the AOA. We will then briefly review the

people on whose shoulders we stand that dedicated their entire careers to OMM related research

and education; they set the foundation and provided the vision for us and future generations to

explore and discover the value and potential of OMT. The effect of OMT research on

professional political and socioeconomics will be touched upon briefly. There have been only

three studies published comparing the value of DO patient care vs MD patient care and each has

had a major impact on the relations between these professions and the socioeconomics of




osteopathic medicine. Selected research studies will be presented that demonstrate the unique

osteopathic approach to inflammatory or infectious conditions using OMT. The osteopathic

profession made its name by helping patients with these conditions, in addition to treating

patients with back and neck pain and other painful musculoskeletal conditions. Examples of

randomized clinical trials investigating the efficacy of OMT for patients with biomechanical

problems, respiration and circulation problems, neurological and behavioral problems will also

be given. Knowing the special issues challenging osteopathic researchers are important in order

to understand why a study was designed the way it was, and its inherent limitations. Lastly,

where to go for more information will be covered succinctly.




DEFINITIONS OF OSTEOPATHIC RESEARCH

There is not one definition of the terms “osteopathic research”. Of the five listed below, the

last one is favored by the American Osteopathic Association Council on Research and the one I

would like for you to consider adopting. When considering a research design or results of a

study, if you can explain the relevance of the study to the principles, theory, mechanisms and

practice of osteopathic medicine, then it is osteopathic (practice relevant) research.

1) National Institutes of Health (Murray Goldstein, DO): “Any research done under

the auspices of an osteopathic institution;”

2)

National Center for Complementary and Alternative Medicine: “Any research that

explores the actions of the nervous system in controlling various autonomic

functions, or the effects of osteopathic manipulative treatment on immune

function, or other physiological mechanisms underlying treatment efficacy;”

3) Most osteopathic medical students: “Any research attempting to determine the

efficacy or value of osteopathic manipulative treatment;”

4) Irwin Korr, PhD: “Any research investigating the effect of the total interaction of

the osteopathic physician and the patient;”

5) AOA Council of Research: “The investigator seeking funding needs to explain

how the hypothesis and expected findings of his or her proposed research would

be relevant to the theory, mechanisms, or practice of osteopathic medicine.”

So, the definition of osteopathic research is left up to the person using the term. If you can link

the relevance of the research to osteopathic principles and practices (OP&P) then it can be

labeled as “osteopathic research”, regardless of who did the research or at which institution.

Having understood this, the focus of this chapter cannot possibly include all of the OP&P




relevant research; instead, it will focus on research regarding osteopathic manipulative treatment

(OMT) or the osteopathic approach to patient care, which includes the practice of OMT.

STANDING ON THE SHOULDERS OF GIANTS

We are indebted to the dedicated career researchers in osteopathic manipulative medicine

whose scientific evidence of the mechanisms underlying the efficacy of osteopathic methods

provided a firm foundation for our procedures and practices. Andrew Taylor Still, MD, DO, was

the first osteopathic researcher, basing his theories and mechanistic explanations on the science

of anatomy. Before the turn of the 20

th

century, faculty at Still’s American School of Osteopathy

began investigating the circulation of blood with the newly discovered Roentgen (x-ray)

machines.

Soon after osteopathic medicine spread to states other than Missouri where the inaugural

college was founded, Louisa Burns, DO began a 50 year long research inquiry into the field of

somato-visceral reflexes, answering the questions:

1) What is the relationship between spinal joint fixation and visceral (organ) disease

processes?

2) What are the paraspinal muscle manifestations of visceral disease processes?

Louisa Burns, DO (1870 -1958) was the Director of the A.T. Still Research Institute from

1917-1935 and directed her own research laboratory in Pasadena until 1955.1 She was a

Professor at the College of Osteopathic Physicians and Surgeons in Los Angeles, CA. Using

animals (mostly rabbits) as her model, she discovered that paraspinal muscles in the

experimentally lesioned areas had an increase in the lactic acid content, edema of the striated

muscle fibers, and congestion of small blood vessels and capillaries associated with muscle




fibrosis. She demonstrated that a diseased organ caused palpable changes in the paraspinal soft

tissues at the spinal levels receiving afferent information travelling centrally via the sympathetic

and parasympathetic nerves innervating the diseased organ. Other researchers that followed her

were able to reproduce her findings (e.g., Wilbur Cole, DO at the College of Osteopathic

Medicine in Kansas City, MO2).

Dr. Burns also organized the second national data collection study for osteopathic care of a

particular patient population. (The first was a national effort to gather osteopathic medical

records from DOs who cared for influenza patients in 1918). In the 1950s, she gathered medical

records from DOs around the country asking for structural findings related to any heart condition

or disease. She found that besides upper thoracic spine dysfunction, the most common area of

vertebral dysfunction was the upper cervical region, and in particular, the OA joint.

J. Steadman Denslow, DO (1906-1984) was a Professor at the Kirksville College of

Osteopathic Medicine. Osteopathic researchers J. S. Denslow, DO and Irvin M. Korr, PhD

conducted studies from the 1940s to the early 1960s that provided evidence of segmental spinal

cord hyperactivity.3 They called this activity “facilitated spinal segments.” They reported

evidence of spontaneous electromyographic (EMG) activity and increased sympathetic output at

spinal levels associated with clinically detected segmental dysfunctions.4 Denslow also

promoted the development of standardized osteopathic terminology, such as “tissue texture

changes”, “altered quality or quantity of motion”, “asymmetry of structure”, “tenderness”, and

“temperature changes”, later summarized as the acronym TART that is still in use today.

Irvin M. Korr, PhD (1909-2004) was Professor of Physiology at Kirksville College of

Osteopathic Medicine at the time of his research; later he also taught at MSU-COM and TCOM.

Korr developed the “facilitated segment” concept, where he proposed that minor trauma to




segmentally innervated musculature could produce a discordant barrage of afferent input from

muscle spindle proprioceptors into the dorsal horn of the spinal cord and alter the firing

thresholds and excitability of the interconnecting neurons. All activity passing through that

segment would become exaggerated, producing increased nociception (pain), α and γ motor

activity to segmental muscles, and sympathetic output. Korr’s neurological model was an

attempt to explain the clinical findings of segmental dysfunction: tenderness and pain due to

facilitated ascending nociception, joint range of motion restriction due to the resistance of

shortened and overactive muscles, and tissue texture changes due to sustained muscle contraction

and sympathetic induced circulatory changes.

5

Korr was amongst the first to demonstrate that nerves have nutritive (trophic) functions in

addition to signal conduction functions. A denervated kidney will atrophy even if it has adequate

blood supply. Muscles also atrophy if denervated or if a peripheral nerve is pinched by

myofascial structures.

Korr also emphasized that the autonomic and central nervous systems function as organizers

of disease processes. He used the term “sympatheticotonia” and defined it as a state of hyper

sympathetic excitation. Sympatheticotonia is deleterious to health and fosters disease. He

suggested one of the goals of osteopathic manipulative medicine is to decrease

sympatheticotonia by removing somatic dysfunction. Dr. Korr, however, promoted clinical

research of the entire interaction between DO and patient instead of just the OMT aspect. He did

not, however, carry out any such studies. He was an inspirational speaker and writer, consulted

on numerous osteopathic research endeavors and interpreted the osteopathic philosophy in light

of modern physiological principles. For this he was called “The Second Great Philosopher of

Osteopathic Medicine” (the first being A.T. Still, MD, DO, of course).




William Johnston, DO (1921-2003) was Professor of Family Medicine at MSU-COM. Dr.

Johnston was a pioneer in osteopathic palpatory diagnosis inter-examiner and intra-examiner

reliability studies.6 He demonstrated that it was possible to get two or more osteopathic

physicians to agree on diagnostic methods and their interpretation of the findings on palpatory

exam if they agreed on methods, terminology, and trained with each other to improve reliability.

Additionally, he pioneered validity studies of osteopathic passive motion tests using kinematic

analysis and electromyograms (EMG) of the muscles involved in specific tests of cervical range

or quality of motion. He demonstrated that passive motion muscle firing patterns are the same,

but to a lesser magnitude or intensity than active motion muscle firing patterns. Subjects with

cervical somatic dysfunction have disordered EMG muscle firing patterns whether tested by

active or by passive range of motion testing.

Another area Johnston pioneered was palpation of the paraspinal soft tissues in response to

passive spinal motion from another spinal region to distinguish between somato-somatic and

viscero-somatic spinal reflexes. He used these procedures to report on the only longitudinal

evaluation of spinal somatic dysfunction over time in patients with or without hypertension. He

also reported on the findings of passive motion tests to distinguish between S-V and V-S reflexes

in patients with renal disease. Lastly, Johnston is known for his delineation of specific

procedures of evaluation and treatment using functional technique, an OMT method using

passive motions away from the restrictive barrier sense to resolve facilitated spinal cord

segments and somatic dysfunction.




DO VS. MD CARE COMPARATIVE RESEARCH FROM THE 20TH CENTURY

There were three studies comparing DO to MD care in the last century. Two were from a

time when they were politically at odds with each other (1918 and 1932), so were not

collaborative, but retrospective morbidity and mortality reports. The third one took place after

the two professions reconciled (1999) and was a collaborative endeavor, this time a prospective

randomized clinical trial in a select patient population with a rather general but common chief

complaint, low back pain.

During the Spanish Influenza Pandemic in 1918, medical records from 2,445 DOs who

collectively treated 110,122 patients with influenza were sent into a central data gathering office

in Chicago.7 Patients cared for by DOs had only a 0.25% mortality rate, compared to the

national average (MD care) of 3-5%. Practically none of the patients who regularly received

OMT just before or during the pandemic contracted the flu or pneumonia. Mortality with

pneumonia complication under MD care was 30-60%, but under DO care was only 10%. DOs

at that time were not using medications to treat their patients, although MDs were. There were

no antibiotics at that time and most of the deaths were from complications from the influenza,

most commonly pneumonia.

Historical Perspective8

In 1918, the MDs returned from serving as medical officers in the American armed forces

during World War I (1914-18) to find DOs caring for their patients. DOs were barred from

serving as medical officers by the government since the MDs and their nurses refused to serve

alongside them. However, the DOs had replaced MDs in many communities as primary care

physicians while the MDs were at war. A third of the physicians living in, or residing




(“residents”) in the LA County Hospital at the time were DOs. The American Medical

Association (AMA) and American College of Surgeons began to threaten MDs and their

hospitals (including the Los Angeles County Hospital) that associated with DOs: if they

continued to interact with DOs their hospital accreditation and membership in medical societies

would be revoked. Furthermore, the California Medical Licensing Board which at that time was

a composite board with both MD and DO representation, arbitrarily refused to allow DOs to sit

for state licensure exams, and although the licensing board was sued and lost in court, the DOs

were determined to prove their care was worthy of recognition and even better than MD care.

Thus, this report has been referred to by the AOA and DOs worldwide annually, and especially

during flu epidemics, ever since 1918, to counter the AMA’s contentions of DO inferiority and

lend support to the argument that DO care is actually superior to MD care. No prospective

studies in any subsequent influenza outbreaks have been carried out.

At the Los Angeles County Osteopathic Hospital between 1930-32, one of every ten patients

was admitted to the segregated osteopathic unit. So, it wasn’t a planned randomized clinical trial,

nor was it prospective, and patients could switch units (i.e., from MD to DO unit) anytime as this

was a county facility for the poor and indigent who have no means to pay for their health care.

So, they had free choice of care if they did not like their randomization. Nevertheless, most

remained randomized. Morbidity and mortality were less in the DO unit than the MD unit. This

report used clear outcome measures: morbidity and mortality. It compared total patient care for

all conditions for which patients were admitted to the hospital. At the time, the AMA, both at

their House of Delegates, and in their publication, the Journal of the American Medical

Association, declared DOs to be insufficiently trained, incompetent and “quacks”; MDs who

associated with or saw the patients of DOs were considered unethical and would be barred from




the AMA. The DOs had to have their own hospitals as they were barred from practicing

alongside MDs.

The LA County Hospital was the only County Hospital in the world that allowed DOs to treat

patients, although in a segregated unit in a separate building from the MDs. (The MD side of the

LA County Hospital actually lost its accreditation as there was an underground corridor between

the segregated buildings for the cleaning crews between 1928-1934 and DOs and MDs could

possibly collaborate; accreditation was restored once a new MD LA County Hospital building

was built a good distance from the DO unit). So, the Chief of Medicine, Dr. Chandler,

meticulously gathered data for three years and reported that the evidence (monthly and annual

morbidity and mortality statistics) showed clearly that the DO care was superior, not inferior to

the MD care.9 (See Dr. Chandler’s personal file in Western University’s Harriet K. and Philip

Pumerantz Library Archives and the article he wrote for the JAOA).

In 1999, the only prospective randomized clinical trial comparing MD with DO care of

patients in America was reported in the prestigious New England Journal of Medicine.10

The

patient population selected for this landmark study was those patients with low back pain greater

than 6 weeks but less than 3 months duration. The outcomes evaluated were pain, disability,

daily activities, medications and physical therapy utilization. Both MDs and DOs could prescribe

medicine and order physical therapy, but the MDs and PTs were restricted in that they could not

perform manipulation, whereas the DOs could. Only patients with lumbar, sacral or pelvic

somatic dysfunction diagnosis were included in the study before randomization. That is, they

were all examined by an osteopathic physician for evidence of TART changes that signified

somatic dysfunction, which is an indication for application of OMT. Outcomes were similar, but

the DOs prescribed fewer medications and referred less to physical therapy (utilization of drugs




and PT were less in the DO group).

The subjects were patients in a Health Maintenance Organization, which means they prepaid

for their health costs through the insurance, so cost effectiveness could not be assessed by this

design. It was determined, however, that patients who select to have OMT and take fewer

analgesics and use less physical therapy services will have the same outcomes of reduced pain

and increased function as if they chose standard medical care and physical therapy, which is the

conventional care for patients with this condition. Interestingly, the MD researcher and physical

therapists in this study also practice manual therapy but were not allowed to use it. So, this study

design was not able to assess whether manual therapy used by PTs, or manual medicine by MDs

gets the same outcomes as OMT by DOs. The additive benefit of all three types of treatments,

e.g., OMT plus medications plus physical therapy, was not assessed.

RANDOMIZED CLINICAL TRIALS

It is helpful to group osteopathic research into the functional categories for which the

techniques are designed, e.g., “metabolic studies” that assess the effects of OMT on

inflammatory, infectious or endocrine system related conditions, “neurological studies” that

assess the effects of OMT on pain or other neurological conditions, “respiratory and circulatory

studies” that assess the effects of OMT on breathing and circulation, and “behavioral studies”

that assess the effects of OMT on, e.g., sleep or depression.

Metabolic Conditions

A. T. Still, MD, DO and his students demonstrated the efficacy of Osteopathic Principles and

Practices, primarily through the use of OMT, in alleviating illness from inflammatory and

infectious diseases. Cellular, animal and human research investigating the effect of OMT on




immunity followed, but not to a great extent. However, osteopathic research in the first 75 years

of the 20th century focused on neurological pathophysiology that characterizes the osteopathic

lesion, now called somatic dysfunction, which can be reversed by OMT (e.g. the works of Burns,

Denslow, Korr and Johnston). Osteopathic research in the last 25 years or so of the 20th century

and the first decade of the new millennium have focused on metabolic or cellular

pathophysiologic processes related to somatic dysfunction and disease, which can be improved

and possibly reversed by OMT. Metabolic perspectives entail the pathophysiologic processes of

inflammation and infection. The studies below were designed to assess the morbidity of a

condition (e.g., pancreatitis, ankle sprain, pneumonia, otitis media) that has a standard of care

recommended by physician expert panels and is upheld by both DOs and MDs. The intervention

being tested is the addition of OMT to the standard practice to see if it decreases the course and

degree of illness. Osteopathic care per se is not on trial here, it is the OMT performed by DOs

that is on trial.

Inflammation

1. Patients hospitalized with pancreatitis (Radjieski et al 1998)11

Hospitalized adult patients with uncomplicated pancreatitis (n= 14) were randomly assigned

to two groups: six received standard care plus OMT; the rest received standard care only. OMT

was provided by an osteopathic family medicine resident physician and entailed a general joint

mobilization of the hips, pelvis, shoulders, sacrum, spine and ribs using standard myofascial

release, articulatory and muscle energy procedures; tenderpoints found on the torso, spine and

extremities were treated with standard strain/counterstrain techniques. Physicians making




medical decisions in regards to treatment and discharge were blinded as to patient group

allocation. Results: Patients in the OMT group spent significantly fewer days in the hospital

before discharge (mean reduction of 3.5 days, p< .039).

2. Emergency patients with ankle sprain (Eisenhart et al 2003)12

Adults who presented to an emergency department with a unilateral first- or second-degree

acute ankle sprain (n=55) were randomized into two groups: one group received standard care

plus OMT and the other group received standard care for acute ankle injuries. An osteopathic

physician resident in emergency medicine provided the OMT which entailed myofascial release

and strain/counterstrain techniques. Results: The OMT group had decrease in edema (P<.001)

and pain (P<.001) immediately after OMT and 1 week later, and increased range of motion (P <

.01) at 1 week follow up.

Infection

1. Hospitalized elderly patients with pneumonia (Noll et al 2000)13

Patients over 60 years of age hospitalized with pneumonia (n= 58) were randomized to one

of two groups: standard care plus OMT or standard care plus light touch sham OMT. OMT and

light touch were provided by osteopathic physicians in residency programs in an osteopathic

post-graduate training hospital and an osteopathic physician specializing in OMT. Results:

There was significantly decreased IV antibiotics use (P<.005), length of stay (P<.014) and total

antibiotics used in the OMT group as compared to the light touch group.




2. Hospitalized elderly patients with pneumonia (Noll et al 2010)14

A multi-site (n=7) randomized, controlled, double-blind, clinical trial evaluated the effect of

OMT on patients over 50 years of age hospitalized with pneumonia (n=406). Participants were

randomized to one of three groups: standard medical care plus OMT, standard medical care plus

light touch (LT) sham or standard care only control group. OMT and light touch were provided

by osteopathic physicians in a neuromusculoskeletal medicine/osteopathic manipulative

medicine residency, and an expert physician board certified in neuromusculoskeletal

medicine/osteopathic manipulative medicine. Physicians managing the patients were blinded to

the patients’ group allocation. All subjects received conventional treatment for pneumonia.

OMT and LT groups received group-specific protocols for 15 minutes, twice daily until

discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The

primary outcomes were hospital length of stay (LOS), time to clinical stability, and symptomatic

and functional recovery scores. Results: Intention-to-treat (ITT) analysis (n = 387) found no

significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant

difference between groups in LOS. Multiple comparisons indicated a reduction in median LOS

(95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5

[3.9-4.9] days) (P = 0.01), but not versus the LT group (3.9 [3.5-4.8] days). Duration of

intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the

CCO group (P = 0.05 and 0.006, respectively), but not versus the LT group.




3. Otitis Media (Mills et al 2003)15

Children 6 months – 6 yrs. of age with recurrent acute otitis media (AOM) (n= 57) were

randomized to one of two groups: standard care plus OMT (n=25) or standard care only (n=32).

OMT was provided by osteopathic physicians specializing in NMM/OMM; the primary care

physician managing the patients was blinded to group allocation. Results: patients in the OMT

group had fewer episodes of AOM (p<.04), surgical procedures (p<.03), more mean surgery-free

months (p<.01), and increased frequency of normal tympanograms (p<.02).

Another aspect of metabolic processes are those involving the endocrine system, and

although pregnancy is not considered pathological, and is self-limiting and episodic, there are

clinical studies regarding the efficacy of OMT in pregnancy.

Pregnancy (King et al 2003)16

OMT has historically been used during pregnancy, but no prospective, randomized clinical

trials have been done on the effect of OMT on delivery and outcomes of the infant or mother.

Studies in the early twentieth century showed decreased labor times, decreased forceps

deliveries, and decreased maternal death. A retrospective study of pregnant patients compared

160 women who received OMT throughout pregnancy to 161 women who did not. The study

demonstrated decreased frequency of meconium-stained amniotic fluid (P<.001) and decreased

occurrence of preterm delivery (P<.01). A marginally significant decrease in the use of forceps

(P < .07) was also shown. This study led to a multi-site, prospective, randomized clinical trial on




the effects of OMT on pregnancy funded by the National Institutes of Health scheduled to

conclude in 2011.

Neurological Conditions

The following clinical trials assess the effect of OMT on a painful condition in a cohort of

patients.

Low Back Pain

1. Ambulatory adults with low back pain (Andersson et al 1999)17 (also presented above)

This randomized, controlled, clinical trial evaluated outcomes (pain, disability, activities)

from MD (n=72) vs. DO (n=83) care of patients (n=155, ages ranged 20-59) with subacute low

back pain (greater than 6 weeks but less than 3 months). Both MDs and DOs could prescribe

medicine and order physical therapy, but the MDs and PTs were restricted in that they could not

perform manipulation, whereas the DOs could. Only patients with lumbar, sacral or pelvic

somatic dysfunction diagnosis were included in the study before randomization. OMT was

performed by DOs who specialized in OMT. Outcomes were similar, but the DOs prescribed

fewer medications (NSAIDS utilized by DOs was 24% vs. 54% for the MDs; muscle relaxants

were used in 6% by DOs vs. 25% by MDs) and referred less to physical therapy (0.2% for DOs

vs. 2.6% for MDs). Patients were equally satisfied with either treatment methods. This is the

only randomized clinical trial in America that compared DO with MD patient care. It was run by

MDs in collaboration with DOs, reported by the MD lead researcher in the New England Journal




of Medicine (November 4, 1999); it was the first and only OMT research article published in that

journal.

2. OMT for back pain during 3rd trimester pregnancy (Licciardone et al 2009)18

A randomized, placebo-controlled trial was conducted to compare usual obstetric care

(UOBC) and osteopathic manipulative treatment (OMT), usual obstetric care and sham

ultrasound treatment (SUT), and usual obstetric care only. Outcomes included average pain

levels and the Roland-Morris Disability Questionnaire to assess back-specific functioning. OMT

was performed by osteopathic physicians specializing in NMM/OMM. Results: Intention-to-

treat analyses included 144 subjects. The Roland-Morris Disability Questionnaire scores

worsened during pregnancy; however, back-specific functioning deteriorated significantly less in

the usual obstetric care plus OMT group (effect size, 0.72; 95% confidence interval, 0.31–1.14; P

= .001 vs usual obstetric care only; and effect size, 0.35; 95% confidence interval, –0.06 to 0.76;

P = .09 vs usual obstetric care and sham ultrasound treatment). During pregnancy, back pain

decreased in the usual obstetric care plus OMT group, remained unchanged in the usual obstetric

care plus sham ultrasound treatment group, and increased in the usual obstetric care only group,

although no between-group difference achieved statistical significance. Osteopathic manipulative

treatment slows or halts the deterioration of back-specific functioning during the third trimester

of pregnancy.

A subgroup analysis of this clinical trial’s data showed that in which the authors looked at 68

patients (47%) identified as having experienced progressive back-specific dysfunction during the

third trimester of pregnancy.19

Patients who received UOBC+OMT were significantly less likely




to experience progressive back-specific dysfunction. The effect sizes for UOBC+OMT vs

UOB+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively.

The corresponding numbers needed to treat (NNTs) for UOBC+OMT were 5.1 vs UOBC+SUT;

and 2.5 vs UOBC.

3. Low back pain meta-analysis and systematic review (Licciardone et al 2005)20

A meta-analysis of randomized controlled studies evaluated the literature for OMT used for

low back pain. Six randomized controlled studies (3 from the United States and 3 from the

United Kingdom), from 1973 to 2001, were reviewed, and they included a total of 525 patients

with low back pain treated by osteopathic physicians. OMT significantly reduces low back pain

in the acute setting (P<.01) with short term (P < .01), intermediate-term (P<.001), and long-term

(P < .03) follow-ups. OMT relieves pain better than both no treatment and placebo controls

(effect size, -0.30; 95% confidence interval, -0.47 to -0.13; P = .001). Pain relief persists for at

least 3 months. This report was used as the basis for the first American Osteopathic Association

Guideline for Use of OMT for Patients with Low Back Pain, published in June 2010 on the

Agency for Healthcare Research and Quality website called the National Guidelines

Clearinghouse, http://www.ngc.gov . It was also published in the JAOA in November 2010.

Further evaluation of low back pain manipulation studies shows that OMT decreases use of

medications (analgesics, anti-inflammatory agents, and muscle relaxants) and physical therapy,

improves physical and psychological outcomes with little additional cost and is more effective

for acute than chronic low back pain.21




Methods

• Randomized, double-blind, sham-controlled, 2 x 2 factorial design

• 455 patients : OMT (n = 230) or sham OMT (n = 225), and to UST (n = 233) or sham

UST (n = 222)

• Six treatment sessions were provided over 8 weeks.

• Intention-to treat analysis was performed to measure moderate and substantial

improvements in low back pain at week 12 (30% or greater and 50% or greater pain

reductions from baseline, respectively).

•

Five secondary outcomes, safety, and treatment adherence were also assessed.

• There was no statistical interaction between OMT and UST.

Patients receiving OMT were more likely than patients receiving sham OMT to achieve

moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P <.001) and substantial (RR =

1.41, 95% CI, 1.13-1.76; P = .002) improvements in low back pain at week 12.

• These improvements met the Cochrane Back Review Group criterion for a medium effect

size.

• Back-specific functioning, general health, work disability specific to low back pain,

safety outcomes, and treatment adherence did not differ between patients receiving OMT

and sham OMT.

• Nevertheless, patients in the OMT group were more likely to be very satisfied with their

back care throughout the study (P <.001).

Results

• Patients receiving OMT used prescription drugs for low back pain less frequently during




the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-

1.00; P = .048).

• Ultrasound therapy was not efficacious.

Strengths

• Largest OMT randomized clinical trial to date.

• Pragmatically assessed OMT as practiced in real-life settings to complement usual care

and self-care for chronic LBP.

•

Used the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

(IMMPACT) consensus statement recommendations for determining moderate and

substantial improvement in low back pain.

• Sham comparator group

• Treatment fidelity training

• Externally blinded physician drug prescribers

• Safety monitoring

• Similarity of baseline patient characteristics across treatment groups

• Intention-to- treat analysis

Subgroup Analysis

Looking at the subjects that had a high level of pain at baseline vs those with low level pain, it

was shown that those with the higher baseline pain level benefited from OMT more.22

• 269 (59%) patients reported low baseline pain severity (LBPS) (<50 mm/100 mm),

whereas 186 (41%) patients reported high baseline pain severity (HBPS) (≥50 mm/100




mm).

HBPS group had substantial (>50%) pain reduction, clinically significant improvement in

back specific functioning and satisfaction with care.

Those subjects with more severe somatic dysfunction had greater changes in cytokines.23

• Interleukin 1Beta and Interleukin 6 levels correlated with number of with number “key”

osteopathic “lesions”, i.e., significant somatic dysfunctions with TART findings.

• TNF alpha changed significantly after 12 weeks of OMT

Those with diabetes also had more severe somatic dysfunction and a better response.24

• 34 (7%) of 455 LBP patients also had DM.

• Severe somatic dysfunction was present significantly more often in patients with DM.

• Patients with DM who received OMT had significant reductions in LBP severity during

the 12-week period.

• Decreased circulating levels of TNF-alpha may be related to the improvement in pain

found in the diabetic subjects.

Post-operative pain (Goldstein et al 2005)25

A randomized, double-blind, controlled clinical trial was performed to assess the effect of

OMT on pain control in post-operative patients after hysterectomy. Thirty-eight hospitalized

patients status post total abdominal hysterectomy participated and were assigned to one of four

treatment groups in addition to standard medical and surgical care:

1) Preoperative saline and postoperative sham manipulative treatment;




2) Preoperative saline and postoperative OMT;

3) Preoperative morphine and postoperative sham manipulative treatment; or

4) Preoperative morphine and postoperative OMT.

Saline (control) or morphine, 10 mg, was delivered intravenously (IV) 10 minutes before

surgical incision. All patients received a postoperative patient-controlled IV analgesia pump

containing morphine. At specified intervals following preoperative IV injections, blood was

drawn and analyzed for morphine concentrations. Subjects were asked to rate their postoperative

levels of pain, nausea, and vomiting. They received sham OMT or OMT (thoracic & lumbar

myofascial soft tissue and sacral myofascial release techniques) three times following surgery.

Results: there were no differences in either pain, or nausea and vomiting scores among the four

study groups. Patients in Group 4 used less morphine than those in the Group 3 for the first 24

hours (P=.02) and from 25–48 hours (P=.01) after elective TAH. Morphine blood concentrations

were lower after 24 hours in Group 4 compared with Group 2 (P=.04). Administration of

postoperative OMT enhanced pre- and postoperative morphine analgesia in the immediate 48-

hour period following elective TAH, demonstrating that OMT can be a therapeutic adjunct in

pain management following this procedure.

Neck pain (McReynolds and Sheridan 2005)26

An effectiveness study (comparing OMT to another commonly used therapy) randomized 58

emergency department patients with less than 3 weeks of neck pain into 2 groups. One group

was treated with standard medical care plus OMT (n=29) and the other was treated with standard

medical care plus ketorolac 30 mg intramuscularly (n=29). Both groups showed a significant




reduction in pain intensity (P<.001), but the OMT group showed a significantly greater decrease

in pain intensity (P < .02).

Fibromyalgia (Gamber et al 2002)27

A randomized, controlled clinical trial of 24 female patients with fibromyalgia assessed the

effect of standard care plus OMT. Participants were randomly assigned into 4 groups:

1) standard care plus OMT;

2) standard care plus OMT and teaching (patients were taught home tender point

treatment);

3) standard care plus moist heat; and

4) standard care only.

Patients were allowed to continue their chronic medications. The OMT group showed

significant improvement in pain threshold, perceived pain, attitude toward treatment, activities of

daily living, and chronic pain.

Headaches

1. Osteopathic manipulative therapy for chronic tension-type headaches was studied in a

randomized, controlled, clinical trial (Anderson and Seniscal 2006)28. Twenty-nine

patients were randomized into a standard care plus osteopathic manipulative therapy

group or a standard care only control group. Both groups did regular home relaxation

exercises and continued chronic medications. Twenty-six people completed the study.




Osteopathic manipulative therapy was performed by a Canadian trained osteopath

practitioner who used a variety of osteopathic techniques. One group received 3

osteopathic treatments (once weekly). Significant improvement was shown for the

osteopathic manipulative therapy group in the number of headache-free days (P = .016).

2. A study looking at the efficacy of OMT for migraine prophylaxis or pain and symptom

reduction was published by Voigt K et al (2011).29

• N=42 (21 randomized to each group)

• MIDAS, SF-36, Pain, HRQoL Questionnaires before and 6 months after OMT

•

OMT 50 minutes x 5 over 10 weeks

• Both groups continued medication regimen

Results:

• Significantly reduced pain and working disability, improved HRQoL (p<.05) in OMT

group

Italian osteopaths published a study on the efficacy of OMT for pain control in spinal cord

injured patients.30

• N=47 (33 complete lesion; 14 incomplete; 26 nociceptive and neuropathic pain; 21 pure

neuropathic pain; 39 M, 8 F; Pain >6/10. >2 years post SCI and 6 months stable)

• Randomized: Meds vs Meds plus OMT vs OMT

Results:

• Combination of meds plus OMT had most reduced pain response




Respiratory and Circulatory Conditions

The following clinical trials assess OMT effects on pulmonary or cardiovascular functions.

Asthma (Guiney et al 2005)31

A randomized, controlled trial evaluated the effect of OMT on peak flow measurements in

children with asthma.32

One hundred forty patients (ages ranged from 5-17) with asthma were randomly assigned to two

groups: standard medical care plus OMT (n=90) or standard medical care with light touch

placebo (n=50). OMT was performed by various osteopathic physicians and the placebo was

provided by an MD physician. The OMT group showed a statistically significant improvement of

7 L per minute to 9 L per minute for peak expiratory flow rates (95% confidence level).

Sinusitis

An MD used OMT techniques to treat her patients with chronic sinusitis and found they (n=15)

improved. She had no formal training, but read the OMT procedures in a book and consulted

with a DO faculty member at a college of osteopathic medicine.33

Peripheral Artery Disease (Lombardini et al 2009)34

Researchers in Italy investigated whether OMT could alter the course of peripheral vascular

disease and symptoms of claudication.

Design

• OMT provided by a foreign-trained osteopath

• Case-controlled

pilot study




• To determine the effect of osteopathic manipulative

therapy on peripheral artery disease

(PAD) in patients with intermittent claudication.

• Outcomes measured

– Blood lipids, sVCAM-1, sICAM-1, IL-6

– Brachial artery flow-mediated vasodilation, ankle-arm blood pressure index

– Treadmill test performance ed vasodilation, ankle-

– Health-related quality of life questionnaire

Subjects

• 15

non-smoking men with PAD elected to receive 6 months of osteopathic

manipulative

therapy.

• These subjects were matched with 15 similar

patients (age, medical treatment) who did

not receive manipulation.

• All

subjects maintained their current treatment regimens (ie, aspirin, angiotensin-

converting

enzyme inhibitors, statins) throughout the study.

Intervention

• At each session, the osteopath performed a structural examination to identify areas of

somatic dysfunction, which was treated using one or more of the following techniques:

• craniosacral therapy; high-velocity, low amplitude; lymphatic pump; muscle energy;

myofascial release; soft tissue; and strain/counterstrain.

• In the first 2 months, manipulation was provided for 30 minutes every 2 weeks.

• In the third month, patient response to manipulation was

assessed and techniques were

adjusted to improve responses.

• In the last 3 months, manipulation was applied every 3 weeks.




Conclusions

At 6 months, OMT group had statistically significant increases (P<.05) in

• brachial flow–mediated vasodilation

• ankle/brachial pressure index

• treadmill testing

• and the physical health component of quality-of-life measures

• Univariate analysis in the OMT group revealed a negative correlation between changes in

brachial

flow–mediated vasodilation and IL-6 levels

• a positive correlation between claudication pain onset time and physical function score.

• Only 3 patients complained of transient muscle tenderness, and no new pathologies or

complications were reported.

• No difference existed

between groups in total walk time, but there was a significant

difference

in time to claudication pain favoring the OMT group.

• However, the

first is likely to be a marker of functional status, and the

second outcome

measure is subjective.

Strengths

• Power analysis

• Functional outcome measures

• Long term follow up

Limitations

• Small sample size




• Lack of randomization

• Lack of placebo manipulation

• Absence of protocol violation discussion

Post Coronary Artery Bypass Graft (CABG) surgery (O-Yurvati et al 2005)35

To determine the effects of OMT on cardiac hemodynamics post-CABG surgery, researchers

performed a prospective clinical study on 10 patients post CABG who received OMT within two

hours of the surgery while unconscious and still under the influence of anesthesia; results were

compared to 19 matched controls not treated with OMT. The primary assessment compared pre-

OMT versus post-OMT thoracic impedance, mixed venous oxygen saturation (SvO2), and

cardiac index. Records of control subjects who underwent CABG surgery, but who did not

receive OMT, were assessed for SvO2 and cardiac index at 1 hour and 2 hours post surgery.

Osteopathic physicians specializing in OMT performed primarily myofascial release OMT

procedures to alleviate anatomic dysfunction of the rib cage caused by median sternotomy and to

improve respiratory function. Results: A post-OMT increase in thoracic impedance (P<.02) in

OMT subjects demonstrated that central blood volume was reduced after OMT, suggesting an

improved peripheral circulation. Mixed venous oxygen saturation also increased (P<.005) after

OMT. These increases were accompanied by an improvement in cardiac index (P<.01).

Comparisons of postoperative measurements in OMT subjects versus those in control subjects

revealed statistically significant differences for SvO2 (P<005) and cardiac index (P<.02)

between the two groups.




Behavioral Conditions

Sleep (Cutler et al 2005)36

To determine if osteopathic cranial manipulation (osteopathy in the cranial field) is

associated with altered sleep latency. and muscle sympathetic nerve activity (MSNA) as a

potential mechanism for altered sleep latency, researchers recruited twenty (20) healthy

volunteers (12 male, 8 female; age range, 22–35 years) and randomized them to one of three

groups: compression of the fourth ventricle (CV4), CV4 sham (simple touch), and control (no

treatment). Sleep latency was assessed during each of the interventions in 11 subjects, using the

standard Multiple Sleep Latency Test protocol. Concurrently, directly recorded efferent MSNA

was measured during each of the interventions in the remaining 9 subjects, using standard

microneurographic technique. Results: Sleep latency during the CV4 trial was decreased when

compared to both the CV4 sham or control trials (P< .05). MSNA during the CV4-induced

temporary halt of the cranial rhythmic impulse (stillpoint) was decreased when compared to

prestillpoint MSNA (P<.01). During the CV4 sham and control trials MSNA was not different

between CV4 time-matched measurements (P>.05). Moreover, the change in MSNA prestillpoint

to stillpoint during the CV4 trial was different compared to the CV4 sham and control trials

(P<.05). However, this change in MSNA was similar between the CV4 sham and control trials

(P> .80).

Depression (Plotkin et al 2001)

37

In a randomized controlled clinical trial 17 patients with depression were randomly assigned

to a standard care plus OMT (n=8) or standard care plus placebo group (n=9). Standard care

consisted of paroxetine anti-depressant medication and psychotherapy. The placebo consisted of




a standard structural evaluation but no actual OMT. Osteopathic student physicians administered

the structural exams and OMT under the direction of an OMT specialist faculty. All subjects in

the OMT group reverted to normal Zung Depression Scale scores compared to only 33% of those

in the placebo group by week 8.

Cost Effectiveness of OMT

OMT has been argued to be a cost effective approach to management of patients with low back

pain.38. Reduced expenses of episode of care was determined by retrospective chart review:

Radiology - $63.81 less

Medications - $19.53 lower

Total overall costs = #38.26 lower




SPECIAL CONSIDERATIONS IN OMM RESEARCH39

Blinding

It is almost impossible to blind the person doing OMT although it is possible to blind the

patient from being able to distinguish between a sham OMT and the real thing. Some

researchers have advocated for training lay persons to do manual procedures that are used in

clinical practice to assess the efficacy of the technique rather than the experienced healing hands

and attitude of the healer that can be confounders of the data. Currently, OMT studies blind the

subjects with a sham OMT procedure, or other procedure that has no effect such as an ultrasound

machine that is not turned on, as well as the data analyzers and the physicians evaluating the

subjects before and after the OMT procedure or sham.

Control Groups and Placebo or Sham OMT

There are several control group designs used in OMT clinical studies. Some studies use a

wait-list control in which all subjects are evaluated at time zero, then some are treated with OMT

while others wait and receive it later, which tracks the natural course of a condition before the

intervention; some use a cross over design, in which those who didn’t get OMT initially because

they were randomized to the sham group then get the OMT and the initial OMT group

conversely gets the sham.

Placebo OMT would appear to benefit the patient as much as true OMT, but it would have no

inherent power to resolve somatic dysfunction or alter physiology. Placebo interventions have

included unplugged ultrasound machines (with lights flashing) since patients have stated it

appears as if it would help as much as OMT. It is a challenge to devise a placebo for OMT as

most manipulative interventions have some physiological effect. The ‘placebo effect’ is




measurements attributed to the patient’s response to the placebo intervention. This could be from

the procedure, the environment or the provider-subject interaction. Often with OMT clinical

trials, the touching, the attention given to the subject by the provider of the OMT, and the

environment have all been implicated as causing unintentional physiological effects. “Sham

OMT” is similar to what people consider to be placebo. A sham is an intervention that has been

shown to, or is thought to, not be able to treat the condition being studied, in this case, somatic

dysfunction. “Sham OMT” procedures used by researchers have included performance of

routine osteopathic structural exam procedures, hands on touching without moving, touching

non-related anatomical landmarks, and moving joints unrelated to the somatic dysfunction. A

touching sham is better than a no-touch sham since it helps account for the potential effects of

touching the subjects. Indeed, touching a subject alters physiology more than not touching at all,

and since OMT uses touch, a design that includes a touching sham helps researchers discern how

much of an effect is due to the touch alone vs. the actual application of OMT.

Randomized clinical trials of OMT compared to a sham treatment have had mixed results:

OMT has been shown to be more efficacious than sham OMT or ultrasound in

reducing pain in patients with low back pain and improving peak air flow in patients

with asthma; but

OMT has been shown to be equivocal to sham OMT for patients hospitalized with

pneumonia or sham ultrasound for relieving low back pain in those who are

pregnant in the third trimester ; however,

OMT was better than sham ultrasound in those who are pregnant in the third

trimester in terms of halting progressive back specific dysfunction, especially in those

subjects with more severe progressive back specific dysfunction.




Drop-out or Attrition of Subjects

If an OMT sham is used, will those patients drop out of the study because of lack of benefit?

This might be a problem in studies in which the subjects have a previous knowledge of OMT and

can distinguish between OMT and its sham. Will subjects drop out because they don’t like the

OMT side effects? Some types of OMT that are direct and uncomfortable, like inhibitory OMT

procedures that employ a sustained deep pressure (referred to as ischemic pressure since it is

sufficient pressure to stop blood flow to and from the area) are not typically used in research

trials. HVLA and Muscle Energy OMT can also cause some post treatment soreness and pain.

Indirect techniques do not as much, but can also cause some discomfort for a couple of days as

the body adjusts to the somatic dysfunction corrections. There are statistical tests used to

account for the drop out or attrition of subjects, such as “last visit carry forward” or “intention to

treat” methods that attempt to predict the effect of the intervention if the subject remained in the

study.

Sample Size and Power

Most early osteopathic research studies are considered by current researchers to have

insufficient numbers of subjects to make definitive conclusions. More recent studies have used a

“power analysis” prior to enrollment of subjects to ensure adequate sample size is obtained to

answer the research questions posed with the least chance for making false conclusions. The

more groups in a study, the larger the sample size needs to be. So, for example, if a study has

four groups to which subjects are randomized, i.e., a sham OMT group, an OMT group, a

conventional care group and a combined sham plus OMT group, then the sample size will need




to be at least twice as large as an OMT vs. conventional care group. However, if the difference

between the effect of the interventions is small, e.g., between sham OMT, real OMT and

conventional care, then even more subjects are needed to be able to distinguish the difference

between groups since the effect may be small for some populations. This has led to multi-site

OMT clinical trials to gather sufficient numbers of subjects to be able to have enough statistical

power to discern the difference that OMT makes in patient care. Practice Based Research

Networks of osteopathic clinicians are now in vogue to facilitate multi-site data gathering.

Standardized Protocols

Osteopathic clinicians use osteopathic principles in the practice of osteopathic medicine.

Although OMT procedures are fairly standardized, the clinician modifies the techniques

according to the response of the patient as the treatment is in progress. Not only is the diagnosis

of somatic dysfunction based on A.R.T. (Asymmetry of structure, Restriction of motion, Tissue

texture abnormalities) but the treatment using OMT is also part art. However, in research, it is

most important to design a study that is reproducible by other researchers in order to convince

others that the results are true. So, for others to be able to reproduce the study, the OMT used

has to be reproducible in the hands of others. At first, OMT studies used the most expert person

around, but when others more novice OMT clinicians or students tried to reproduce the studies

they could not get the same results. When a study with OMT novices gets negative results, the

experts complain that an expert person should have been used. But if OMT is beneficial, and all

physicians should use it, then it should be teachable and effective in any student’s hands who has

performed competently in school, or in a post-graduate course. Researchers initially used only

one OMT technique as the intervention, but clinicians complained this was not applicable to their

practices because typically a series of OMT procedures are used. In order to determine which




OMT procedures are best to use for a clinical condition, clinical OMT trials have evolved to

include standardized protocols based on the research literature and pilot research studies. If a

protocol proves effective, then further studies can follow that try to delineate which aspects of

the protocol are more efficacious than other parts. Sometimes, and OMT protocol may worsen a

clinical condition. In this instance, researchers need to figure out which procedure, which

provider and which modulation of the technique was responsible for the results obtained.

Inclusion/Exclusion Criteria

An interesting dilemma facing research designers of OMT clinical trials is whether to include

subjects whether or not they have been diagnosed with somatic dysfunction. Consider this

question: Should OMT procedures be performed on subjects without a diagnosis of somatic

dysfunction (e.g., patients with “low back pain”, “headache”, or “pancreatitis”)? Whereas some

OMT procedures, such as the lymphatic pump, the CV4, and the post-op ileus paraspinal muscle

inhibition procedures, do not require a specific segmental diagnosis of somatic dysfunction,

many other procedures require presence of findings of T.A.R. and/or T. changes in order to

indicate the need for OMT.

Most clinical trials exclude subjects who have co-morbidities, are pregnant, or if they are

children. Should these populations be excluded from OMT clinical trials even though the

majority of patients seen by DOs in clinical practice have co-morbidities? As the National

Institutes of Health encourages the inclusion of children and pregnant subjects in clinical

research, more osteopathic clinical trials are now being done in these populations. A few clinical

trials have included patients with co-morbidities, but most researchers would rather limit the

study to subjects with a single condition to control for potential confounding variables.




Another issue discussed among researchers is whether subjects should be included only if

they are naïve to OMT (never been manipulated) to limit subject bias. In some areas such as

Kirksville, MO where osteopathic medicine has been practiced for over 125 years it may be

difficult to find subjects who have not been treated with OMT. Larger metropolitan areas and

rural areas where DOs are sparse are better suited for this type of exclusion criteria without

drastically hindering enrollment.

Dependent Variables/Selecting Appropriate Measures

Certainly it is preferable to have clear outcome measures whenever possible, such as

mortality. This may be appropriate for a study on the effects of OMT on pneumonia in elderly

hospitalized patients, but since OMT is most often used in ambulatory patients who are not

dying, this measure in unrealistic. What measures are available? OMT clinical trials have

employed pulmonary function tests, heart rate variability, sympathetic nerve activity, immune

function tests, radiological evaluations, Doppler ultrasound and blood and lymph flow velocity

meters. Standardized and validated surveys, e.g., the SF-36 and the Rolland-Morris Disability

Scale, should be used when applicable. Patient subjective measures are useful, such as pain

scales, feelings of well-being, satisfaction with care provided, and functional (activities of daily

living) abilities.

Research on Comprehensive Osteopathic Care vs. OMT as an adjunct or alternative to

allopathic care

Should the entire osteopathic experience be considered unique and not just OMT? Both have

been done; both are needed. Comprehensive osteopathic care may or may not entail utilization




of OMT, and may vary in the utilization of medications and physical therapeutics. Some designs

use only a technique, i.e., HVLA to the lumbar spine. This is not the same as employing

osteopathic manipulative medicine (OMM), which would entail a structural exam, identification

of somatic dysfunctions, and treatment to relieve it and other compensatory dysfunctions

throughout the region or in other body regions; OMM also involves a management plan. Several

OMT procedures can be used in an OMM trial, but not in a single technique OMT trial. OMM

trials can evaluate such factors as optimal duration, frequency, synergy and variety of OMT

applied to a subject. Single technique trials can evaluate forces and the direct or global response

to the single intervention, rather than the global response to global interventions as in the case of

a full OMM trial.

RESOURCES

A good resource in general for OMT study design can be found in the research chapters at

the back of the Foundations of Osteopathic Medicine textbook.40

Also, see the website of the

American Academy of Osteopathy (AAO) at http://www.academyofosteopathy.org and look

under “research” and “manual” for the Louisa Burns Osteopathic Research Committee’s manual

and application for research funding from the AAO.

Books and proceedings from conferences on OMT, including somato-visceral and viscero-

somatic interactions and central nervous system and immune system interactions, have been

published and available from the American Osteopathic Association41 and the American

Academy of Osteopathy.42

Books for the clinician in practice on evidence based osteopathic

manual medicine are also available.43




Online database resources include:

• OSTMED.DR, Pub Med (Medline), OVID, EMBASE, Cochrane, MANTIS databases;

• JAOA articles are available online at www.jaoa.org .

You can find mentors for osteopathic research endeavors at the American Academy of

Osteopathy Louisa Burns Osteopathic Research Committee, at the Colleges of Osteopathic

Medicine, and through the Osteopathic Research Center at the University of North Texas Health

Science Center.

STUDY QUESTIONS

1) What is the definition of osteopathic research used by the AOA Bureau of Research?

2) Which osteopathic researcher was known for pioneering inter-examiner reliability and validity

studies?

3) Which osteopathic researcher was known for differentiating viscero-somatic dysfunction

using motion tests?

4) Which osteopathic researcher was known for demonstrating the trophic function of nerves?

5) Which osteopathic researchers were known for demonstrating the facilitated spinal cord

segment?

6) Which osteopathic researcher was known for demonstrating the effects of somatovisceral

reflexes using the animal model?

7) Which osteopathic researcher was the first career osteopathic researcher?

8) Which osteopathic researcher gathered medical records from osteopathic doctors nationwide




to determine that the OA dysfunction is the most common somatic dysfunction in patients with

cardiovascular problems?

9) What were the differences between osteopathic patient mortality compared with MD patient

mortality during the 1918 flu pandemic?

10) What were the results of the mortality differences between DO and MD patients at the LA

County Hospital in the early 1930s.

11) What were the results of the 1999 study comparing DO and MD care of patients with low

back pain?

12) What were the results of the studies on the efficacy of OMT for dysfunctions in the five

models: metabolic (e.g., patients with pancreatitis and ankle sprain), respiratory/circulatory (e.g.,

otitis media, pneumonia, asthma and sinusitis, peripheral vascular disease, post sternotomy

CABG surgery, angina), neurologic (e.g., low back pain, neck pain, headache, post

hysterectomy, spinal pain), behavioral (e.g., sleep latency and depression)?

13) What is the cost effectiveness of OMT in patients with low back pain?

14) What is the efficacy of OMT vs. sham interventions?

15) What are the challenges for researchers investigating OMT efficacy?

16) Where can you find more research articles?

17) Where can you find mentors if you want to do an OMT research study?

1 Beal MC, Ed. Louisa Burns, DO Memorial, Indianapolis: American Academy of Osteopathy;1994. 2 Beal MC, Ed. The Cole Book of Papers Selected from the Writings and Lectures of Wilbur V.

Cole, DO, FAAO. Indianapolis: American Academy of Osteopathy; 1985.3 Beal MC, Ed. Selected Works of John Stedman Denslow, DO. Indianapolis: American

Academy of Osteopathy; 1993.




4 J. S. Denslow, Irvin M. Korr and A. D. Krems. Quantitative studies of chronic facilitation inhuman motoneuron pools. The American Journal of Physiology; Vol 150; Aug 1 ,1947; No. 2.5 Peterson B, Ed. The Collected Papers of Irvin M. Korr. Indianapolis: American Academy ofOsteopathy; 1979.6

Beal MC, Ed. Scientific Contributions of William L. Johnston, DO, FAAO. Indianapolis:American Academy of Osteopathy; 1998.7 Smith RK. One hundred thousand cases of influenza with a death rate of one-fortieth of thatofficially reported under conventional medical treatment [reprint of J Am Osteopath Assoc.1920;19:172-175]. J Am Osteopath Assoc. 2000;100:320-323. Available at:http://www.jaoa.org/cgi/reprint/100/5/320. Accessed July 11, 2011.8 Reinsch S, Seffinger MA, Tobis JS. The Merger: MDs and DOs in California. XLibris Press.2009. 9 Chandler LB. Osteopathic versus medical hospital efficiency. J Am Osteopath Assoc. Dec1932:144-146. 10 Andersson GBJ, Lucente T, Davis AM et al. A comparison of osteopathic spinal manipulation

with standard care for patients with low back pain. NEJM, Nov 4, 1999: 1426-1431.

11 Radjieski JM, Lumley MA, Cantieri MS. Effect of osteopathic manipulative treatment onlength of stay for pancreatitis: a randomized pilot study [published correction appears in J AmOsteopath Assoc. 1998;98:408]. J Am Osteopath Assoc. 1998,98:264–272.12 Eisenhart AW, Gaeta TJ, Yens DP. Osteopathic manipulative treatment in the emergencydepartment for patients with acute ankle injuries. J Am Osteopath Assoc, 2003, 103(9):417-421. 13 Noll DR, Shores JH, Gamber RG, et al. Benefits of osteopathic manipulative treatment forhospitalized elderly patients with pneumonia. J Am Osteopath Assoc. Dec 2000;100(12):776-82.Comment in: J Am Osteopath Assoc. 2001,101(8):427-8. 14 Noll DR, Degenhardt BF, Morley TF, Blais FX, Hortos KA, Hensel K, et al. Efficacy ofosteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a

randomized controlled trial. Osteopathic Medicine and Primary Care 2010, 4:2; available onlineat http://www.om-pc.com/content/4/1/2. 15 Mills MV, Henley CE, Barnes LLB, Carreiro JE, Degenhardt BF. The use of osteopathicmanipulative treatment as adjuvant therapy in children with recurrent acute otitis media. ArchPediatr Adolesc Med, 2003, 157: 861-866. 16 King HH, Tettambel MA, Lockwood MD, Johnson KH, Arsenault DA, Quist R. OsteopathicManipulative Treatment in Prenatal Care: A Retrospective Case Control Design Study. J AmOsteopath Assoc, 2003,103 (12): 577-582. 17 Andersson GBJ, Lucente T, Davis AM et al. A comparison of osteopathic spinal manipulationwith standard care for patients with low back pain. NEJM, Nov 4, 1999: 1426-1431. 18

Licciardone JC, Buchanan S, Hensel KL, King HH, Fulda KG and Stoll ST. Osteopathicmanipulative treatment of back pain and related symptoms during pregnancy: a randomizedcontrolled trial. Am J Obstet Gynecol. Online in Press Sept 19, 2009.doi:10.1016/j.ajog.2009.07.05719 Licciardone JC, Aryal S. Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane back review groupcriteria. J Am Osteopath Assoc. 2013 Oct;113(10):728-36.




20 Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC MusculoskeletDisord, 2005;6:43. Available at http://www.biomedcentral.com/1471-2474/6/43/21 Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment

and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med .2013;11(2):122-129. 22 (Licciardone JC, et al., Outcomes of osteopathic manual treatment for chronic low back pain

according to baseline pain severity: Results from the OSTEOPATHIC Trial, Manual Therapy(2013),http://dx.doi.org/10.1016/j.math.2013.05.006)23 Licciardone JC, Kearns CM, Hodge LM, Bergamini MVW. Associations of CytokineConcentrations With Key Osteopathic Lesions and Clinical Outcomes in Patients With Nonspecific Chronic Low Back Pain: Results from the OSTEOPATHIC Trial, (2012) JAOA112(9):596-605. JAOA, September 2012 (112)9:596-605. 24 Licciardone JC, Kearns CM, Hodge LM, Minotti DE .Osteopathic manual treatment in patients

with diabetes mellitus and comorbid chronic low back pain: subgroup results from the

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25 Goldstein, F., et. al., F, Jeck S, Nicholas AS, Berman, MJ, Lerario M. Effect of pre-emptivemorphine and postoperative osteopathic manipulative technique on pain following totalabdominal hysterectomy: a pilot study. J Am Osteopath Assoc, 2005,105(6):273-279. 26 McReynolds TM, Sheridan BJ. Intramuscular Ketorolac versus osteopathic manipulativetreatment in the management of acute neck pain in the emergency department: a randomizedclinical trial, J Am Osteopath Assoc, 2005,105(2):57-68. 27 Gamber RG, Shores JH, Russo DP, Jimenez C, Rubin BR. Osteopathic manipulative treatment

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29 Voigt K, Liebnitzky J, BurmeisterU, Sihvonen-Riemenschneider H, Beck M, Voigt R,Bergmann A. Efficacy of Osteopathic Manipulative Treatment of Female Patients with Migraine:Results of a Randomized Controlled Trial. J Alter Complement Med, 2011, 17(3):225-230 30 Arienti C, Dacco S, Piccolo I, Redaelli T. Osteopathic manipulative treatment is effective on pain control associated to spinal cord injury. Spinal Cord, 2010, 16 December 2010;doi:10.1038/sc.2010.17031 Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of Osteopathic Manipulative Treatmenton Pediatric Patients With Asthma: A Randomized Controlled Trial. J Am Osteopath Assoc,2005, 105(1): 7-12. 32 Lombardini R, Marchesi S, et al. The use of OMT as adjuvant therapy in patients with

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33 Lee-Wong M, Karagic M, Doshi A, Gomez S, Resnick D (2011) An osteopathic approach tochronic sinusitis. J Aller Ther 2:109 34 Lombardini R, Marchesi S, et al. The use of OMT as adjuvant therapy in patients with peripheral arterial disease. Man Ther (2009) 14:493-443 35 O-Yurvati AH, Carnes MS, Clearfield MB, Stoll ST, McConathy WJ. Hemodynamic effects

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36 Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can altersleep latency and sympathetic nerve activity in humans: A pilot study. J Altern Comp Med,2005,11(1):103-108. 37 Plotkin BJ, Rodos JJ, Kappler R, Schrage M, Freydl K, Hasegawa S et al. Adjunctive

osteopathic manipulative treatment in women with depression: a pilot study. J Am OsteopathAssoc. 2001,101(9),517-523. 38 Crow WT, and Willis DR, Estimating Cost of Care for Patients With Acute Low Back Pain: ARetrospective Review of Patient Records. J Am Osteopath Assoc, Apr 2009; 109: 229 – 233 39 See:

Patterson M. Foundations for Osteopathic Research, in RC Ward, Exec. Ed. Foundationsfor Osteopathic Medicine. Philadelphia: LWW, 2003:1167-1187.

Patterson MM. Osteopathic Research: Challenges of the Future, in RC Ward, Exec. Ed.Foundations for Osteopathic Medicine. Philadelphia: LWW, 2003:1219-1228.

Patterson MM. Research in OMT: What Is the Question and Do We Understand It? J Am

Osteopath Assoc. January 2007; 107(1): 8-11.

Licciardone JC, Russo DP. Blinding protocols, treatment credibility, and expectancy:methodologic issues in clinical trials of osteopathic manipulative treatment. J Am Osteopath Assoc. 2006;106:457-463.

Licciardone JC. Osteopathic research: elephants, enigmas, and evidence. Osteopathic

Medicine and Primary Care; 2007;1:7. This article is available from: http://www.om- pc.com/content/1/1/7.

Licciardone JC. Responding to the challenge of clinically relevant osteopathic research:efficacy and beyond. Int J Osteopath Med . 200; March 10(1):3.

Foresman BH, D’Alonzo GE and Jerome JA. Biobehavioral Interactions with Diseaseand Health, in RC Ward, Exec. Ed. Foundations for Osteopathic Medicine. Philadelphia:LWW, 2003:1203-1214.

Fulda KG, Slicho T and Stoll ST. Patient expectations for placebo treatments commonlyused in osteopathic manipulative treatment (OMT) clinical trials: a pilot study.Osteopathic Medicine and Primary Care 2007, 1:3. This article is available from:http://www.om-pc.com/content/1/1/3.

40 Chila AG, Exec. Ed. Foundations of Osteopathic Medicine. Philadelphia: Lippincott, Williams,

Wilkins, 2011.41 Northup GW, ed. Osteopathic Research: Growth and Development. Chicago, IL: AmericanOsteopathic Association, 1987. 42

See

Patterson MM, Howell JN, Eds. The Central Connection: Somatovisceral ViscerosomaticInteraction. Indianapolis: American Academy of Osteopathy; 1992.

Willard F, Patterson MM, Eds. Nociception and the Neuroendocrine-ImmuneConnection. Proceedings of the 1992 American Academy of Osteopathy InternationalSymposium. Indianapolis: American Academy of Osteopathy; 1994.

43 See: Seffinger MA, Hruby RJ. Evidence Based Manual Medicine; A Problem Oriented

Approach. Philadelphia: Saunders 2007.

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