Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01741168|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Thoracolumbar Burst Fractures Without Neurologic Deficit||Other: TLSO Other: No Orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2011|
Active Comparator: TLSO
TLSO brace 8-10 weeks
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.
Other Name: TLSO Aspen Medical Products, Irvine, CA, USA
Experimental: No Orthosis
Other: No Orthosis
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.
- Roland Morris Disability Questionnaire [ Time Frame: 3 months post fracture ]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.
- SF-36 physical component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years ]
- SF-36 mental component summary score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
- VAS pain score [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]
- Satisfaction with Treatment [ Time Frame: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741168
|London Spine Centre|
|London, Ontario, Canada, N6A 5W9|