Status:
TERMINATED
Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Low Back Pain
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT02261233
Start Date
April 1 2014
End Date
August 31 2018
Last Update
January 4 2019
Active Locations (3)
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1
MSU Osteopathic Manipulative Medicine
East Lansing, Michigan, United States, 48823
2
MSU Musculoskeletal Rehabilitation
Lansing, Michigan, United States, 48891
3
Michigan State University Center for Orthopedic Research
Lansing, Michigan, United States, 48910