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Clinical Trials/NCT00316342
NCT00316342
Completed
Phase 3

Workplace Based Rehabilitation for Low Back Disorders

Rush University Medical Center0 sites433 target enrollmentJanuary 1997
ConditionsLow Back Pain

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Rush University Medical Center
Enrollment
433
Primary Endpoint
Back pain disability
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1997
End Date
November 2004
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Back pain disability

Low back pain repeated episodes

Low back pain

Neurogenic symptoms

Physical health

Mental health

Lost work time

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