Lumbar microdiscectomy and post-operative activity restrictions: a protocol for a single blinded randomised controlled trial

BMC Musculoskeletal Disorders

Study Protocol

Naor Bar-Zeev¹  Mohammed Molla²  Jennifer Lewis²  Kelly Saber³  Kai Zheong Lim⁴  Chris D. Daly⁵  Tony Goldschlager⁶ 

[1] Centre for Global Vaccine Research, Institute of Infection & Global Health, University of Liverpool, Liverpool, UK;Department of Neurosurgery, Monash Medical Centre, Clayton, VIC, Australia;Department of Physiotherapy, Monash Medical Centre, Clayton, VIC, Australia;Department of Surgery, Monash University, Clayton, VIC, Australia;Department of Neurosurgery, Monash Medical Centre, Clayton, VIC, Australia;Department of Surgery, Monash University, Clayton, VIC, Australia;Department of Neurosurgery, Monash Medical Centre, Clayton, VIC, Australia;The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Clayton, VIC, Australia;Department of Surgery, Monash University, Clayton, VIC, Australia;Department of Neurosurgery, Monash Medical Centre, Clayton, VIC, Australia;The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Clayton, VIC, Australia;Department of Neurosurgery, Cabrini Hospital, Malvern, VIC, Australia;

关键词: Lumbar Discectomy;    Spine;    Restrictions;    Post-Operative;    Sitting;   

DOI  :  10.1186/s12891-017-1681-3

 received in 2016-12-20, accepted in 2017-07-16,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundLumbar microdiscectomy is the most commonly performed spinal surgery procedure, with over 300,000 cases performed annually in the United States alone. Traditionally, patients were advised to restrict post-operative activity as this was believed to reduce the risk of disc reherniation and progressive instability. However, this practice would often delay patients return to work. In contemporary practice many surgeons do not restrict patient post-operative activity due to the perception this practice is unnecessary. We describe a randomised controlled trial to assess the impact of activity restrictions on clinical outcome following lumbar discectomy.Methods/DesignThe lumbar microdiscectomy and post-operative activity restriction trial is a multi-centre, randomised, controlled single blinded trial. Two hundred ten patients due to undergo single level lumbar microdiscectomy without a history of previous spine surgery, infection or fracture are randomised to be advised either restricted or unrestricted activity for a period of 30 days following lumbar microdiscectomy. Actual adherence with trial allocation will be monitored bioelectronically via a wearable device. Outcome assessment at follow up will occur at 1, 3, 6 and 12 months. The primary outcome will be a composite endpoint comprising changes in Visual Analogue Scale (Leg and Back), Oswestry Disability Index and the absence of intervertebral disc reherniation or secondary intervention.DiscussionThis randomised controlled trial will directly compare post-operative protocols of activity restrictions and no restrictions following lumbar discectomy with adherence monitored bioelectronically.Trial RegistrationAustralian New Zealand Clinical Trials Registry: ACTRN12616001360404 (retrospectively registered 30/09/2016).

【 授权许可】

CC BY   
© The Author(s). 2017