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

NCT ID: NCT00269347

Last Updated: 2005-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Keywords

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Chiropractic Manual Therapy Exercise Randomized Clinical Trial Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Chiropractic Spinal Manipulation

Intervention Type PROCEDURE

Exercise

Intervention Type PROCEDURE

Self-care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Berman Center for Outcomes and Clinical Research

OTHER

Sponsor Role collaborator

Northwestern Health Sciences University

OTHER

Sponsor Role lead

Principal Investigators

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Gert Bronfort, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Health Sciences University

Locations

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Northwestern Health Sciences University

Bloomington, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23661035 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21622028 (View on PubMed)

Related Links

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http://www.nwhealth.edu/research/WHCCS

Related Info

Other Identifiers

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R18HP10009

Identifier Type: -

Identifier Source: org_study_id