Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

Study Overview
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Brief Summary
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The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of postural control of the trunk. In order to accomplish this goal, we aim to quantify balance performance in an unstable seated task. Specifically, the investigators will quantify balance performance in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in balance performance after a single session of osteopathic manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and this improvement will be greater than any learning effect. A secondary objective of this study is to quantify differences in patient-oriented outcome measures (e.g., self-reported pain, disability) in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in these self-reported outcomes following osteopathic manipulative treatment. The association between improvement in postural control parameters and patient-oriented measures will also be explored.

Official Title
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Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Osteopathic manipulative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for LBP participants: Age 21-65 years Independently ambulatory Able to speak and read English Able to understand study procedures and to comply with them for the entire length of the study. Willing to be randomized to either immediate or delayed treatment group. Musculoskeletal pain - primarily in the low back region Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded. Below is a list of exclusion criteria: Inability or unwillingness of individual to give written informed consent. Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment Workers' compensation benefits in the past 3 months or ongoing medical legal issues Possibly pregnant Obesity (BMI>32) Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.) History of: Spinal surgery Spinal fracture Spinal infection (e.g., osteomyelitis) Cancer Unresolved symptoms from: Head trauma Inner ear infection with associated balance and coordination problems Orthostatic hypotension Uncontrolled hypertension Vestibular disorder (e.g. vertigo) Current diagnosis of: Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis) Ankylosing spondylitis Spondylolisthesis grades III or IV Cauda equine syndrome Rheumatoid arthritis Osteoporosis Angina or congestive heart failure symptoms Active bleeding or infection in the back Blindness Seizures Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia) Conditions recognized by a physician any time during the study: Significant or worsening signs of neurologic deficit Symptoms are not consistent with mechanical findings Other conditions impeding protocol implementation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment<br>This arm receives osteopathic manipulative treatment shortly after enrollment | Procedure: Osteopathic manipulative treatment<br>* Up to 4 sessions of osteopathic manipulative treatment (once per week)<br>|
| Experimental: Delayed treatment<br>This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment | Procedure: Osteopathic manipulative treatment<br>* Up to 4 sessions of osteopathic manipulative treatment (once per week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural control | Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees. | Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8. | 
| Change in trunk muscle reflex latency | Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds. | Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | 
| Change in concomitant medication | Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks. | 
| Change in Oswestry Disability Index | Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | 
| Change in fear avoidance behavior | Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). |