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Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.
The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLSO | Active Comparator | TLSO brace 8-10 weeks |
|
| No Orthosis | Experimental | No Orthosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLSO | Other | Patients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Disability Questionnaire | The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities. | 3 months post fracture |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 physical component summary score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years | |
| SF-36 mental component summary score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Spine Centre | London | Ontario | N6A 5W9 | Canada |
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| No Orthosis | Other | Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks. |
|
| VAS pain score | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Satisfaction with Treatment | Overall satisfaction with treatment was assessed on a seven point scale, using the sentence, "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture?" This is a recommended tool for assessing global satisfaction. | enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months |