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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chiropractic Spinal Manipulation
Exercise
Self-care
Sponsored by
Northwestern Health Sciences University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chiropractic, Manual Therapy, Exercise, Randomized, Clinical Trial, Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern Health Sciences University

Outcomes

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

Full Information

First Posted
December 21, 2005
Last Updated
December 22, 2005
Sponsor
Northwestern Health Sciences University
Collaborators
HRSA/Maternal and Child Health Bureau, Berman Center for Outcomes and Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00269347
Brief Title
Manipulation, Exercise, and Self-Care for Low Back Pain
Official Title
Manipulation, Exercise, and Self-Care for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern Health Sciences University
Collaborators
HRSA/Maternal and Child Health Bureau, Berman Center for Outcomes and Clinical Research

4. Oversight

5. 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.
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: chiropractic spinal manipulation rehabilitative exercise 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: To examine the short and long-term relative cost effectiveness and cost utility of the three treatments. 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. 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. To identify if baseline demographic or clinical variables can predict short or long-term outcome. To describe patients' interpretations and perceptions of outcome measures used in clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chiropractic, Manual Therapy, Exercise, Randomized, Clinical Trial, Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Chiropractic Spinal Manipulation
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Type
Behavioral
Intervention Name(s)
Self-care
Primary Outcome Measure Information:
Title
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Secondary Outcome Measure Information:
Title
Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
Title
General Health (SF-36) at baseline, weeks 4,12,26,52
Title
Improvement (7 point scale) at baseline, weeks 4,12,26,52
Title
Disability (NHIS) at baseline, weeks 4,12,26,52
Title
Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
Title
Frequency (7 point scale) at baseline, weeks 4,12,26,52
Title
Satisfaction (5 point scale) at baseline, weeks 4,12,26,52
Title
Depression (CES-D) at baseline, weeks 4,12,26,52
Title
Medication use at baseline, weeks 4,12,26,52
Title
Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52
Title
Lumbar range of motion at baseline, weeks 4,12,26,52
Title
Lumbar strength and endurance at baseline, weeks 4,12,26,52
Title
Health care costs and utilization at baseline, weeks 4,12,26,52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert Bronfort, DC, PhD
Organizational Affiliation
Northwestern Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Health Sciences University
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23661035
Citation
Haanstra TM, Hanson L, Evans R, van Nes FA, De Vet HC, Cuijpers P, Ostelo RW. How do low back pain patients conceptualize their expectations regarding treatment? Content analysis of interviews. Eur Spine J. 2013 Sep;22(9):1986-95. doi: 10.1007/s00586-013-2803-8. Epub 2013 May 10.
Results Reference
derived
PubMed Identifier
21622028
Citation
Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH Jr, Owens EF Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011 Jul;11(7):585-98. doi: 10.1016/j.spinee.2011.01.036. Epub 2011 May 31.
Results Reference
derived
Links:
URL
http://www.nwhealth.edu/research/WHCCS
Description
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Manipulation, Exercise, and Self-Care for Low Back Pain

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