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

Abstract

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).

Proliferation, Migration, and ECM Formation Potential of Human Annulus Fibrosus Cells Is Independent of Degeneration Status

“…Thus, the herniated disc is usually removed by a lumbar discectomy, the standard procedure annually carried out in more than 300,000 cases in the United States. 6,7 But none of these methods are completely successful. Current research focuses on the regeneration potential of the NP by different scaffold materials, but since the damaged AF is not closed/repaired during this procedure, up to 23% of the patients suffer from recurring herniation of the NP 8 or the applied implant.…”

Perioperative care for lumbar microdiscectomy: a survey of Australasian neurosurgeons

“…The study was, however, underpowered to detect a significant difference in reherniation rates. We are currently performing the first randomized controlled trial comparing a patient group observing no post-operative activity restrictions with a control group observing a one month period of activity restrictions (24). Additionally, our study will track patient adherence to activity restrictions following spine surgery through use of a wearable activity monitory, an innovation of importance given the difficulty of verifying patient adherence to activity restrictions through self-report.…”

Patient journey following lumbar discectomy surgery: protocol for a single-centre qualitative analysis of the patient rehabilitation experience (DiscJourn)

“…Evidence also highlights variation in postdiscectomy management (including referral to physiotherapy content, advice and guidance offered)10 30 31 and survey results31 showed lack of consistency in postoperative advice with restricted activities, including sitting, lifting, return to work and driving, advocated for a variety of postoperative periods. Several studies also challenge the need for postlumbar discectomy restrictions32–34 with a single-blinded randomised controlled trial now underway 35. Current practice inconsistencies may reflect the limited evidence guiding clinicians resulting in lack of consensus.…”