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| Sponsors and Collaborators: |
Rush University Medical Center The UAW-GM National Joint Committee on Health & Safety |
|---|---|
| Information provided by: | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00316342 |
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 III |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Workplace Based Rehabilitation for Low Back Disorders |
| Estimated Enrollment: | 433 |
| Study Start Date: | January 1997 |
| Study Completion Date: | November 2004 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
| Responsible Party: | Rush University Medical Center ( Dr. Gunnar Andersson ) |
| Study ID Numbers: | 95050341, #97-1-AP |
| Study First Received: | April 18, 2006 |
| Last Updated: | November 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00316342 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Low back pain Industrial workers Recurrent back pain |
Back supports Back health education Rehabilitation |
|
Signs and Symptoms Neurologic Manifestations Low Back Pain |
Pain Back Pain Recurrence |
|
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |
