Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316342
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2006-04-18
Brief Title:
Workplace Based Rehabilitation for Low Back Disorders
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Workplace Based Rehabilitation for Low Back Disorders
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AHR0711 95 CI 050 104 p085 There was also a marginal effect of back supports and education on decreasing low back pain over time AHR00015 p0091
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
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 AHR0711 95 CI 050 104 p085 There was also a marginal effect of back supports and education on decreasing low back pain over time AHR00015 p0091
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-1-AP | None | None | None |