The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity. If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment. Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.
Participants will not wear a brace in the study.
Duke University Medical Center
Durham, North Carolina, United States
Change in Oswestry Disability Index (ODI) score
Scores from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)
Measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Change in Visual Analogue Scale (VAS)
Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
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