SUcceSS: SUrgery for Spinal Stenosis – a randomised placebo-controlled trial
The aim of this randomised placebo-controlled trial is to establish the efficacy, safety and cost-effectiveness of decompressive surgery compared to placebo surgery in improving pain, function and quality of life in people with chronic symptoms due to central lumbar spinal canal stenosis.
The SUcceSS trial will randomly allocate 160 people with symptomatic central lumbar spinal canal stenosis, who have failed to respond to a course of conservative care, to receive either decompressive surgery or placebo surgery. The placebo surgery arm will receive identical treatment to the active arm except that no bone removal will be performed. Patients, investigators other than the treating surgeon, and assessors will be blinded to treatment allocation. Post-operative management will be identical for both groups. The primary outcome will be pain in the lower limb, measured on a numerical rating scale. Secondary outcomes will include disability measured using the Roland Morris Disability Questionnaire, walking tolerance, quality of life and self-reported perceived recovery. A trial based cost-effectiveness analysis will be performed.