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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Chris D. Daly, Kai Zheong Lim, Jennifer Lewis, Kelly Saber, Mohammed Molla, Naor Bar-Zeev, Tony Goldschlager

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

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Abstract

Background

Lumbar 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/Design

The 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.

Discussion

This randomised controlled trial will directly compare post-operative protocols of activity restrictions and no restrictions following lumbar discectomy with adherence monitored bioelectronically.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12616001360​404 (retrospectively registered 30/09/2016).
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Metadata
Title
Lumbar microdiscectomy and post-operative activity restrictions: a protocol for a single blinded randomised controlled trial
Authors
Chris D. Daly
Kai Zheong Lim
Jennifer Lewis
Kelly Saber
Mohammed Molla
Naor Bar-Zeev
Tony Goldschlager
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1681-3

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