Manipulation, Exercise, and Self-Care for Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00269347|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : December 23, 2005
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Chiropractic Spinal Manipulation Procedure: Exercise Behavioral: Self-care||Phase 2|
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:
- chiropractic spinal manipulation
- rehabilitative exercise
- 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:
- To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.
- 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.
- 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.
- To identify if baseline demographic or clinical variables can predict short or long-term outcome.
- To describe patients' interpretations and perceptions of outcome measures used in clinical trials.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Manipulation, Exercise, and Self-Care for Low Back Pain|
|Study Start Date :||January 2001|
|Estimated Study Completion Date :||April 2005|
- Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269347
|United States, Minnesota|
|Northwestern Health Sciences University|
|Bloomington, Minnesota, United States, 55431|
|Principal Investigator:||Gert Bronfort, DC, PhD||Northwestern Health Sciences University|