Abstract
BackgroundThe life-time incidence of low back pain is high and diagnoses of spinal stenosis and disc prolapse are increasing. Consequently, there is a steady rise in surgical interventions for these conditions. Current evidence suggests that while the success of surgery is incomplete, it is superior to conservative interventions. A recent survey indicates that there are large differences in the type and intensity of rehabilitation, if any, provided after spinal surgery as well as in the restrictions and advice given to patients in the post-operative period.This trial will test the hypothesis that functional outcome following two common spinal operations can be improved by a programme of post-operative rehabilitation that combines professional support and advice with graded active exercise and/or an educational booklet based on evidence-based messages and advice.Methods/DesignThe study design is a multi-centre, factorial, randomised controlled trial with patients stratified by surgeon and operative procedure. The trial will compare the effectiveness and cost-effectiveness of a rehabilitation programme and an education booklet for the postoperative management of patients undergoing discectomy or lateral nerve root decompression, each compared with "usual care"using a 2 × 2 factorial design. The trial will create 4 sub-groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care only. The trial aims to recruit 344 patients, which equates to 86 patients in each of the four sub-groups. All patients will be assessed for functional ability (through the Oswestry Disability Index - a disease specific functional questionnaire), pain (using visual analogue scales), and satisfaction pre-operatively and then at 6 weeks, 3, 6 and 9 months and 1 year post-operatively. This will be complemented by a formal analysis of cost-effectiveness.DiscussionThis trial will determine whether the outcome of spinal surgery can be enhanced by either a post-operative rehabilitation programme or an evidence-based advice booklet or a combination of the two and as such will contribute to our knowledge on how to manage spinal surgery patients in the post-operative period.Trial RegistrationCurrent controlled trials ISRCTN46782945UK CRN ID: 2670
Highlights
The life-time incidence of low back pain is high and diagnoses of spinal stenosis and disc prolapse are increasing
Currently we are approaching the end of the Bone & Joint Decade, which at its onset identified low back pain (LBP) as one of its main focuses [1]
Whilst LBP is not a life threatening condition it does affect a large proportion of the population with a point prevalence of between 12-35% and a lifetime prevalence of 49-80%[2]
Summary
The life-time incidence of low back pain is high and diagnoses of spinal stenosis and disc prolapse are increasing. A recent survey indicates that there are large differences in the type and intensity of rehabilitation, if any, provided after spinal surgery as well as in the restrictions and advice given to patients in the post-operative period. This trial will test the hypothesis that functional outcome following two common spinal operations can be improved by a programme of post-operative rehabilitation that combines professional support and advice with graded active exercise and/or an educational booklet based on evidence-based messages and advice. Whilst the prevalence of back pain is high, a survey in 1994 by the Office of Population Censuses and Surveys indicated that only 10% of affected individuals attend an NHS outpatient clinic and only 0.5% undergo any surgical intervention[3]. Inpatient treatment, of which surgery is a key component, forms the largest single element of overall expense to the NHS related to back pain[4], possibly as high as 30% of the overall direct cost of back pain[5]
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