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Open Access Study protocol

Effectiveness and cost-effectiveness of rehabilitation after lumbar disc surgery (REALISE): design of a randomised controlled trial

Teddy Oosterhuis1*, Maurits van Tulder12, Wilco Peul34, Judith Bosmans1, Carmen Vleggeert-Lankamp3, Lidwien Smakman3, Mark Arts4 and Raymond Ostelo12

Author Affiliations

1 Department of Health Sciences, Faculty of Earth and Life Science, VU University Amsterdam and the EMGO Institute for Health and Care Research, Amsterdam, The Netherlands

2 Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam and the EMGO Institute for Health and Care Research, Amsterdam, The Netherlands

3 Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands

4 Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands

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BMC Musculoskeletal Disorders 2013, 14:124  doi:10.1186/1471-2474-14-124

Published: 5 April 2013

Abstract

Background

Patients who undergo lumbar disc surgery for herniated discs, are advocated two different postoperative management strategies: a watchful waiting policy, or referral for rehabilitation immediately after discharge from the hospital. A direct comparison of the effectiveness and cost-effectiveness of these two strategies is lacking.

Methods/Design

A randomised controlled trial will be conducted with an economic evaluation alongside to assess the (cost-) effectiveness of rehabilitation after lumbar disc surgery. Two hundred patients aged 18–70 years with a clear indication for lumbar disc surgery of a single level herniated disc will be recruited and randomly assigned to either a watchful waiting policy for first six weeks or exercise therapy starting immediately after discharge from the hospital. Exercise therapy will focus on resumption of activities of daily living and return to work. Therapists will tailor the intervention to the individual patient’s needs. All patients will be followed up by the neurosurgeon six weeks postoperatively. Main outcome measures are: functional status, pain intensity and global perceived recovery. Questionnaires will be completed preoperatively and at 3, 6, 9, 12 and 26 weeks after surgery. Data will be analysed according to the intention-to-treat principle, using a linear mixed model for continuous outcomes and a generalised mixed model for dichotomous outcomes. The economic evaluation will be performed from a societal perspective.

Discussion

The results of this trial may lead to a more consistent postoperative strategy for patients who will undergo lumbar disc surgery.

Trial registration

Netherlands Trial Register: NTR3156

Keywords:
Rehabilitation; Exercise; Physiotherapy; Lumbar disc surgery; Lumbar disc herniation; Randomised controlled trial; Economic evaluation