Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Stopped early · Not applicable
Conditions studied: Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT02261233
- Run by
- Michigan State University
- People needed
- 63
- Starts
- 2014-04-01
- Expected to finish
- 2018-08-31
- Last updated by the study team
- 2019-01-04
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MSU Osteopathic Manipulative Medicine — East Lansing, Michigan, United States
- MSU Musculoskeletal Rehabilitation — Lansing, Michigan, United States
- Michigan State University Center for Orthopedic Research — Lansing, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.