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

This study has been completed.
Sponsor:
Collaborators:
HRSA/Maternal and Child Health Bureau
Berman Center for Outcomes and Clinical Research
Information provided by:
Northwestern Health Sciences University
ClinicalTrials.gov Identifier:
NCT00269347
First received: December 21, 2005
Last updated: December 22, 2005
Last verified: December 2005
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Procedure: Chiropractic Spinal Manipulation
Procedure: Exercise
Behavioral: Self-care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Manipulation, Exercise, and Self-Care for Low Back Pain

Resource links provided by NLM:


Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:
  • Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: January 2001
Estimated Study Completion Date: April 2005
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

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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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269347

Locations
United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
Northwestern Health Sciences University
HRSA/Maternal and Child Health Bureau
Berman Center for Outcomes and Clinical Research
Investigators
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
  More Information

No publications provided by Northwestern Health Sciences University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00269347     History of Changes
Other Study ID Numbers: R18HP10009
Study First Received: December 21, 2005
Last Updated: December 22, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern Health Sciences University:
Chiropractic
Manual Therapy
Exercise
Randomized
Clinical Trial
Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014