ISSLS prize winner: Function After Spinal Treatment, Exercise, and Rehabilitation (FASTER): a factorial randomized trial to determine whether the functional outcome of spinal surgery can be improved.

摘要

STUDY DESIGN: This was a multicenter, factorial, randomized, controlled trial on the postoperative management of spinal surgery patients, with randomization stratified by surgeon and operative procedure. OBJECTIVE: This study sought to determine whether the functional outcome of two common spinal operations could be improved by a program of postoperative rehabilitation that combines professional support and advice with graded active exercise commencing 6 weeks after surgery and/or an educational booklet based on evidence-based messages and advice received at discharge from hospital, each compared with usual care. SUMMARY OF BACKGROUND DATA: Surgical interventions on the spine are increasing, and while surgery for spinal stenosis and disc prolapse have been shown to be superior to conservative management, functional outcome, and patient satisfaction are not optimal. METHODS: The study compared the effectiveness of a rehabilitation program and an education booklet for the postoperative management of patients undergoing discectomy or lateral nerve root decompression surgery, each compared with "usual care" using a 2 x 2 factorial design, randomizing patient to four groups; rehabilitation-only, booklet-only, rehabilitation-plus-booklet, and usual care only. The primary outcome measure was the Oswestry Disability Index (ODI) at 12 months, with secondary outcomes including visual analog scale measures of back and leg pain. RESULTS: Three hundred thirty-eight patients were recruited into the study and measurements were obtained preoperatively and then repeated at 6 weeks, 3, 6, 9 and 12 months postoperatively. Twelve months postoperatively the observed effect of rehabilitation on ODI was -2.7 (95% CI: -6.8 to 1.5) and the effect of booklet was 2.7 (95% CI: -1.5 to 6.9). CONCLUSION: This study found that neither intervention had a significant impact on long-term outcome.