Lumbar Spinal Stenosis Clinical Trial
Official title:
Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.
This study will use a randomised controlled trial to access the efficiency of the surgery for
degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part.
Patients will be randomised divided into 2 arms. The participants in the intervention arm
will have decompression surgery ; those randomised to the control arm will receive current
standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12
and 24 months afterwards. The primary outcome will be the pain release , categorised
according to Oswestry disability index.
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