NCT00269347

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Northwestern Health Sciences University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Chiropractic Spinal Manipulation
PROCEDURE	Exercise
BEHAVIORAL	Self-care

Timeline

• Start date: 2001-01-01
• Completion: 2005-04-01
• First posted: 2005-12-23
• Last updated: 2005-12-23

Locations

1 site across 1 country: United States