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

Northwestern Health Sciences University1 site in 1 country300 target enrollmentJanuary 2001

ConditionsLow Back Pain

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Northwestern Health Sciences University
Enrollment: 300
Locations: 1
Primary Endpoint: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

April 2005

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Northwestern Health Sciences University

Eligibility Criteria

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