We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00269347
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : December 23, 2005
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Manipulation, Exercise, and Self-Care for Low Back Pain
Study Start Date : January 2001
Estimated Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
  2. General Health (SF-36) at baseline, weeks 4,12,26,52
  3. Improvement (7 point scale) at baseline, weeks 4,12,26,52
  4. Disability (NHIS) at baseline, weeks 4,12,26,52
  5. Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
  6. Frequency (7 point scale) at baseline, weeks 4,12,26,52
  7. Satisfaction (5 point scale) at baseline, weeks 4,12,26,52
  8. Depression (CES-D) at baseline, weeks 4,12,26,52
  9. Medication use at baseline, weeks 4,12,26,52
  10. Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52
  11. Lumbar range of motion at baseline, weeks 4,12,26,52
  12. Lumbar strength and endurance at baseline, weeks 4,12,26,52
  13. Health care costs and utilization at baseline, weeks 4,12,26,52

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00269347     History of Changes
Other Study ID Numbers: R18HP10009
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: December 23, 2005
Last Verified: December 2005

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

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