Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach



Status:Terminated
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:21 - 65
Updated:1/6/2019
Start Date:April 1, 2014
End Date:August 31, 2018

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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.


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
We found this trial at
3
sites
Lansing, Michigan 48910
Principal Investigator: Jacek Cholewicki, PhD
Phone: 517-975-3301
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East Lansing, Michigan 48823
Principal Investigator: Jacek Cholewicki, PhD
Phone: 517-975-3301
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East Lansing, MI
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Lansing, Michigan 48891
Principal Investigator: Jacek Cholewicki, PhD
Phone: 517-975-3301
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Lansing, MI
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