Manipulation, Exercise, and Self-Care for Low Back Pain

Phase 2

Completed

• Conditions: Low Back Pain

• Registration Number: NCT00269347
• Lead Sponsor: Northwestern Health Sciences University

Brief Summary

The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.

Detailed Description

Low back pain remains an important public health problem with serious socioeconomic consequences. Despite the considerable amount of research that has been preformed, there is still a dire need for randomized clinical tiles of high methodological quality. The broad, long-term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and increased understanding of this important condition. Building upon the principal investigators' previous collaborative research, this randomized observer-blinded clinical trial will compare the following treatment for patients with nonacute low back pain:

1. chiropractic spinal manipulation

2. rehabilitative exercise

3. self care education Theprimary aim is to examine the relative efficacy of the three interventions in terms of patient rated outcomes in the short-term (after 12 weeks) and the long-term (after 52 weeks) for nonacute low back pain.

Secondary aims include:

1. To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.

2. To assess if there are clinically important differences between pre-specified subgroups of low back pain patients. Subgroups are based on duration and current episode and radiating leg pain.

3. To evaluate if there treatment group differences in objective lumbar spine function (range of motion, strength and endurance) after 12 weeks of treatment and if changes in lumbar function are associated with changes in patient rated short and long-term outcomes.

4. To identify if baseline demographic or clinical variables can predict short or long-term outcome.

5. To describe patients' interpretations and perceptions of outcome measures used in clinical trials.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2005-04
• Status Verified: 2005-12
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-22
• Last Update Submitted: 2005-12-22
• Study First Posted: 2005-12-23
• Last Update Posted: 2005-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

patients are 18-65 years of age; Québec task force classification 1,2,3 and 4 (this includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs); primary complaint of back pain, with current episode greater than or equal to six weeks duration(this includes subacute and chronic patients for whom the study treatments are an option)

Exclusion Criteria

• previous lumbar spine surgery; back pain referred from local joint lesions of the lower extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant or nursing women; pain score of less than 30 percentage points; pending our current litigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Secondary Outcome Measures

Name	Time	Method
Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
General Health (SF-36) at baseline, weeks 4,12,26,52
Improvement (7 point scale) at baseline, weeks 4,12,26,52
Disability (NHIS) at baseline, weeks 4,12,26,52
Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
Frequency (7 point scale) at baseline, weeks 4,12,26,52
Satisfaction (5 point scale) at baseline, weeks 4,12,26,52
Depression (CES-D) at baseline, weeks 4,12,26,52
Medication use at baseline, weeks 4,12,26,52
Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52
Lumbar range of motion at baseline, weeks 4,12,26,52
Lumbar strength and endurance at baseline, weeks 4,12,26,52
Health care costs and utilization at baseline, weeks 4,12,26,52

Trial Locations

Locations (1)

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