An interventional study of Home exercise and Chiropractic Spinal Manipulative Therapy + Home exercise in Sub-acute and Chronic Back-related Leg Pain, sponsored by Northwestern Health Sciences University. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-01-31.
Sponsored by Northwestern Health Sciences University · Not applicable, Interventional, and Treatment
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.
Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
Northwestern Health Sciences University is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chiropractic Spinal Manipulative Therapy + Home exercise
Other: Chiropractic Spinal Manipulative Therapy + Home exercise
Home exercise
Other: Home exercise
Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.
The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
Patient-rated leg pain
Time frame: short-term = 12 weeks; long-term = 52 weeks
Bothersomeness
Time frame: short-term = 12 weeks; long-term = 52 weeks
Frequency
Time frame: short-term = 12 weeks; long-term = 52 weeks
Disability
Time frame: short-term = 12 weeks; long-term = 52 weeks
General Health Status
Time frame: short-term = 12 weeks; long-term = 52 weeks
Fear Avoidance
Time frame: short-term = 12 weeks; long-term = 52 weeks
Patient Satisfaction
Time frame: short-term = 12 weeks; long-term = 52 weeks
Improvement
Time frame: short-term = 12 weeks; long-term = 52 weeks
Medication Use
Time frame: short-term = 12 weeks; long-term = 52 weeks
Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance
Time frame: short-term = 12 weeks
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Northwestern Health Sciences University