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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
Sponsor:
Collaborators:
HRSA/Maternal and Child Health Bureau
Berman Center for Outcomes and Clinical Research
Information provided by:
Northwestern Health Sciences University

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 23, 2005
Last Update Posted Date December 23, 2005
Study Start Date  ICMJE January 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Manipulation, Exercise, and Self-Care for Low Back Pain
Official Title  ICMJE Manipulation, Exercise, and Self-Care for Low Back Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Procedure: Chiropractic Spinal Manipulation
  • Procedure: Exercise
  • Behavioral: Self-care
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 22, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00269347
Other Study ID Numbers  ICMJE R18HP10009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Northwestern Health Sciences University
Collaborators  ICMJE
  • HRSA/Maternal and Child Health Bureau
  • Berman Center for Outcomes and Clinical Research
Investigators  ICMJE
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
PRS Account Northwestern Health Sciences University
Verification Date December 2005

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