Classification-Directed Treatment of Low Back Pain
Completed · Phase 1
Conditions studied: Low Back Pain
In brief
The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.
Key facts
- Study ID
- NCT00802724
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 101
- Starts
- 2007-02-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2012-10-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- People who report a history of chronic LBP for a minimum of 12 months,currently are experiencing LBP symptoms but not in an acute recurrence,
- Between 18 and 60 years of age,
- Able to stand and walk without assistance,
- Able to understand and read English,
- Able to understand and sign a consent form
You may not qualify if…
- Any structural spinal deformity including scoliosis, kyphosis, or stenosis,
- A spinal fracture or dislocation,
- Osteoporosis,
- Ankylosing spondylitis,
- Rheumatoid arthritis,
- Disc herniation,
- Serious spinal complications such as tumor or infection,
- Previous spinal surgery,
- Frank neurological loss, i.e., weakness and sensory loss,
- Pain or paresthesia below the knee,
- Etiology of LBP other than the lumbar spine, e.g., hip joint,
- History of neurologic disease which required hospitalization,
- Active treatment for cancer,
- History of unresolved cancer,
- Pregnancy,
- Magnified symptom behavior,
- Worker's compensation or disability case,
- In litigation for the LBP problem,
- Referral from a specialized pain clinic source,
- Spondylolisthesis
Where it is running
- Washington University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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