Sub-acute and Chronic Back-related Leg Pain
Conditions
Brief summary
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.
Interventions
OTHERHome 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.
OTHERChiropractic Spinal Manipulative Therapy + Home exercise
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.
Sponsors
Department of Health and Human Services
Northwestern Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Back-related leg pain \> 3 on 0 to 10 scale. * Sub-acute or chronic back-related leg pain defined as current episode \> 4 weeks duration. * Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root. * 21 years of age and older. * Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).
Exclusion criteria
* Ongoing treatment for leg or low back pain by other health care providers. * Progressive neurological deficits or cauda equina syndrome. * QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed. * QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking). * Uncontrolled hypertension or metabolic disease. * Blood clotting disorders. * Severe osteoporosis. * Inflammatory or destructive tissue changes of the spine. * Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of low back pain patients which generally have a poorer prognosis. * Pregnant or nursing women. * Current or pending litigation. Patients seeking financial compensation tend to respond differently to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-rated leg pain | short-term = 12 weeks; long-term = 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Frequency | short-term = 12 weeks; long-term = 52 weeks |
| Disability | short-term = 12 weeks; long-term = 52 weeks |
| General Health Status | short-term = 12 weeks; long-term = 52 weeks |
| Fear Avoidance | short-term = 12 weeks; long-term = 52 weeks |
| Bothersomeness | short-term = 12 weeks; long-term = 52 weeks |
| Improvement | short-term = 12 weeks; long-term = 52 weeks |
| Medication Use | 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 | short-term = 12 weeks |
| Patient Satisfaction | short-term = 12 weeks; long-term = 52 weeks |
Countries
United States
Outcome results
None listed