Chiropractic and Self-care for Back-Related Leg Pain

Not Applicable

Completed

• Conditions: Sub-acute and Chronic Back-related Leg Pain
• Interventions: Other: Chiropractic Spinal Manipulative Therapy + Home exercise; Other: Home exercise

• Registration Number: NCT00494065
• Lead Sponsor: Northwestern Health Sciences University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chiropractic Spinal Manipulative Therapy + Home exercise	Chiropractic Spinal Manipulative Therapy + Home exercise
2	Home exercise	Home exercise

Primary Outcome Measures

Name	Time	Method
Patient-rated leg pain	short-term = 12 weeks; long-term = 52 weeks

Secondary Outcome Measures

Name	Time	Method
Disability	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
Bothersomeness	short-term = 12 weeks; long-term = 52 weeks
General Health Status	short-term = 12 weeks; long-term = 52 weeks
Frequency	short-term = 12 weeks; long-term = 52 weeks

Trial Locations

Locations (2)

Northwestern Health Sciences University; 🇺🇸 Bloomington, Minnesota, United States

Palmer Center for Chiropractic Research; 🇺🇸 Davenport, Iowa, United States