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Manipulation, Exercise, and Self-Care for Low Back Pain
This study has been completed.
Study NCT00269347   Information provided by Northwestern Health Sciences University
First Received: December 21, 2005   Last Updated: December 22, 2005   History of Changes

December 21, 2005
December 22, 2005
January 2001
 
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Same as current
Complete list of historical versions of study NCT00269347 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Manipulation, Exercise, and Self-Care for Low Back Pain
Manipulation, Exercise, and Self-Care for Low Back Pain

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.

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.
Phase II
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Low Back Pain
  • Procedure: Chiropractic Spinal Manipulation
  • Procedure: Exercise
  • Behavioral: Self-care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
April 2005
 

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269347
 
R18HP10009
Northwestern Health Sciences University
  • HRSA/Maternal and Child Health Bureau
  • Berman Center for Outcomes and Clinical Research
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Northwestern Health Sciences University
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP