The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
3 months of lumbar brace wear
Hamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGRate of enrolment
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Time frame: 12 months
Rate of study completion
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Time frame: 12 months
Lumbar bone fusion
Status of bone fusion assessed radiologically by CT scan
Time frame: 12 months
Functional Status
The Oswestry Disability Index
Time frame: 3 months, 6 months, 12 months
Pain Status
Visual analog scale (0, no pain to 10, worst pain)
Time frame: 3 months, 6 months, 12 months
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