MedPath

Workplace Based Rehabilitation for Low Back Disorders

Phase 3
Completed
Conditions
Low Back Pain
Registration Number
NCT00316342
Lead Sponsor
Rush University Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
433
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Back pain disability
Low back pain repeated episodes
Low back pain
Neurogenic symptoms
Physical health
Lost work time
Mental health
Secondary Outcome Measures
NameTimeMethod
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