ArticleBMJ open2019
SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: an updated systematic review.BMJ open · 2022Pooled it
- The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults With Neurogenic Claudication: The BOOST Randomized Controlled Trial.The journals of gerontology. Series A, Biological sciences and medical sciences · 2022Trial
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- Interspinous Process Devices Do Not Reduce Intervertebral Foramina and Discs Heights on Adjacent Segments.Journal of pain research · 2022Article
- Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.Health technology assessment (Winchester, England) · 2021Article
- Challenges faced by musculoskeletal health research in Australia and New Zealand due to the COVID-19 pandemic.Internal medicine journal · 2021Article
- Proposed objective scoring algorithm for assessment and intervention recovery following surgery for lumbar spinal stenosis based on relevant gait metrics from wearable devices: the Gait Posture index (GPi).Journal of spine surgery (Hong Kong) · 2019Article
Corrections and comments
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Authors and funding
14 authors at 8 institutions in 2 countries.
Funding
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 ANALYSIS: SUcceSS 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 DISSEMINATION: Ethics 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 NUMBER: ACTRN12617000884303; Pre-results.
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