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

December 22, 2005 updated by: Northwestern Health Sciences University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Northwestern Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern Health Sciences University

Collaborators

HRSA/Maternal and Child Health Bureau
Berman Center for Outcomes and Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

December 23, 2005

Last Update Submitted That Met QC Criteria

December 22, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18HP10009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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