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Workplace Based Rehabilitation for Low Back Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316342
First Posted: April 20, 2006
Last Update Posted: November 29, 2007
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.
Collaborator:
The UAW-GM National Joint Committee on Health & Safety
Information provided by:
Rush University Medical Center
  Purpose
The purpose of this study is to examine the effect of back supports plus education upon recovery from a work-related low back disorder. The study tests the hypothesis: the use of back supports plus health education is not different from health education alone in promoting recovery from a work-related low back disorder in consideration of personal, health, and job factors. Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over the twelve months of study follow-up. No statistically significant difference between the study groups was found with respect to these measures.

Condition Intervention Phase
Low Back Pain Device: Back supports Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Workplace Based Rehabilitation for Low Back Disorders

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Low back pain
  • Back pain disability
  • Neurogenic symptoms
  • Physical health
  • Mental health
  • Low back pain repeated episodes
  • Lost work time

Estimated Enrollment: 433
Study Start Date: January 1997
Study Completion Date: November 2004
Detailed Description:

BACKGROUND Low back pain remains a common major source of morbidity and disability. Few studies consider the effectiveness of interventions for low back pain while simultaneously considering personal, health, and job characteristics.

METHODS This is a randomized clinical trial in which 433 active employees with low back disorders were randomly assigned to one of two study groups: 1) back support plus education on back health; or 2) education on back health only. Demographic, health, medical, and job factors were recorded. Outcomes were evaluated over a twelve month period and included self-reported measures of back pain, back pain disability level, physical health, mental health, back pain recurrence and administrative measures.

RESULTS Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over time in both study groups. However, there was no significant difference between the study groups with respect to these outcome measures. The adjusted hazard ratio of recurrence rate was suggestive of an incremental protective effect due to back supports over education alone (adjusted hazard ratio [AHR]=0.711, 95% CI 0.50, 1.04, p=.085). There was also a marginal effect of back supports and education on decreasing low back pain over time (AHR=0.0015, p=0.091).

CONCLUSIONS Back supports may have some value in promoting recovery from low back pain, but this effect is only observed in individuals who are actively employed in jobs with medium risk of low back disorders.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

work-related low back disorder, 18-64 years of age,active hourly worker, enrollment into study within eight weeks of diagnosis, signed informed consent

Exclusion Criteria:

no other concurrent work-related condition not pregnant

  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): NCT00316342


Sponsors and Collaborators
Rush University Medical Center
The UAW-GM National Joint Committee on Health & Safety
Investigators
Principal Investigator: Denise M Oleske, PhD Rush University Medical Center
  More Information

Publications:
Responsible Party: Dr. Gunnar Andersson, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00316342     History of Changes
Other Study ID Numbers: 95050341
#97-1-AP
First Submitted: April 18, 2006
First Posted: April 20, 2006
Last Update Posted: November 29, 2007
Last Verified: November 2007

Keywords provided by Rush University Medical Center:
Low back pain
Industrial workers
Recurrent back pain
Back supports
Back health education
Rehabilitation

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