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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
192
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.
Palmer Center for Chiropractic Research
Davenport, Iowa, United States
Northwestern Health Sciences University
Bloomington, Minnesota, United States
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
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