Chiropractic and Self-care for Back-Related Leg Pain

Study Overview
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Brief Summary
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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.

Official Title
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Chiropractic and Self-care for Back-Related Leg Pain

Conditions
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Sub-acute and Chronic Back-related Leg Pain

Intervention / Treatment
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* Other: Home exercise
* Other: Chiropractic Spinal Manipulative Therapy + Home exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chiropractic Spinal Manipulative Therapy + Home exercise | Other: Chiropractic Spinal Manipulative Therapy + Home exercise<br>* 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.<br>|
| Active Comparator: 2<br>Home exercise | Other: Home exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated leg pain |  | short-term = 12 weeks; long-term = 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bothersomeness |  | short-term = 12 weeks; long-term = 52 weeks | 
| 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 | 
| Patient Satisfaction |  | 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 |