SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial

Abstract

IntroductionCentral lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial —the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS.Methods and analysisSUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained.Ethics and disseminationEthics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences.Trial registration numberACTRN12617000884303; Pre-results.

Prospective study on the treatment of degenerative lumbar spinal canal stenosis: Surgical versus conservative intervention

“…These finding were in consistent with Anderson and collegues [25], who reported that, the surgical groups had higher complication rates than non-surgery groups throughout the follow-up duration.…”

“…Two studies determined that patients were satisfied with X-STOP implanted at 6 weeks, 6 months, and 12 months after surgery[8]. In addition, Anderson and collegues[25] reported good postsurgery responsiveness, in the form of increased walking ability at 3 months follow up besides decreased neurogenic claudications at 6 and 12 months follow up durations.The current trial showed, that operative treatment was more effective in reducing pain and disability than conservative treatment in patients with LSS, and that the beneficial effect sustained throughout the 1-year follow-up. The difference was statistically significant at 3, 6, and 12 months.…”

Lumbar spinal stenosis

“…Ongoing trials are evaluating surgery and physiotherapy interventions in patients with LSS, which will add to the evidence 3132…”

Challenges faced by musculoskeletal health research in Australia and New Zealand due to the COVID‐19 pandemic

“…2 In 2015, musculoskeletal researchers, clinicians and consumers from Australia and New Zealand established a binational collaborative research initiative known as the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network. 3 The aim of the network is to support multicentre trials of the highest quality to provide definitive answers to the most pressing questions in the musculoskeletal field, such as whether spinal decompression is superior to placebo in patients with spinal stenosis 4 or whether surgery is more effective than conservative treatment for fractures in the distal radius in the elderly. 5 During 2020, the ANZMUSC network has been an excellent platform for understanding the impact of the COVID-19 pandemic on musculoskeletal research in Australia and New Zealand.…”