Function after spinal treatment, exercise and rehabilitation (FASTER): improving the functional outcome of spinal surgery.
BACKGROUND
The 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
The 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 x 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.


CONCLUSIONS
This 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.
McGregor
A H
AH
Surgery & Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital Campus, London W6 8RP, UK. a.mcgregor@imperial.ac.uk
Doré
C J
CJ
Morris
T P
TP
Morris
S
S
Jamrozik
K
K
D000203:Activities of Daily Living; D003376:Counseling / Q000379:methods; D019299:Decompression, Surgical / Q000534:rehabilitation*; D004185:Disability Evaluation; D017586:Diskectomy / Q000534:rehabilitation*; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery; D017116:Low Back Pain / Q000534:rehabilitation / Q000601:surgery; D008159:Lumbar Vertebrae / Q000601:surgery; D019635:Neurosurgical Procedures / Q000534:rehabilitation*; D017063:Outcome Assessment, Health Care / Q000379:methods; D010174:Pamphlets; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000379:methods; D018579:Patient Selection; D010809:Physical Fitness / Q000502:physiology / Q000523:psychology; D011183:Postoperative Complications / Q000534:rehabilitation*; D011184:Postoperative Period; D011788:Quality of Life; D011843:Radiculopathy / Q000601:surgery; D012046:Rehabilitation / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design; D012648:Self Care; D013130:Spinal Stenosis / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome