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

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
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DOI:
10.1097/brs.0b013e318214e3e6
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发表时间:
2011-10-01
期刊:
影响因子:
3
通讯作者:
Jamrozik, Konrad
Jamrozik, Konrad
中科院分区:
医学2区
文献类型:
--
作者:
McGregor, Alison H.;Dore, Caroline J.;Jamrozik, Konrad

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研究设计.这是一项关于脊柱手术患者术后管理的多中心、析因、随机、对照试验,随机化按外科医生和手术程序分层。目的。本研究旨在确定两种常见脊柱手术的功能结果是否可以通过术后康复计划得到改善,该计划将专业支持和建议与术后6周开始的分级主动锻炼和/或基于出院时收到的循证信息和建议的教育小册子相结合,每种都与常规护理进行比较。对脊柱的手术干预正在增加,虽然手术治疗椎管狭窄和椎间盘脱出已被证明上级保守治疗,但功能结局和患者满意度并不理想。该研究比较了接受椎间盘切除术或外侧神经根减压术患者术后管理的康复计划和教育手册的有效性,每一个都使用2x2析因设计与“常规护理”进行比较,将患者随机分为四组:仅康复组、仅手册组、康复加手册组和仅常规护理组。主要结局指标是12个月时的奥斯韦斯特里残疾指数(ODI),次要结局指标包括背部和腿部疼痛的视觉模拟量表。338例患者被招募入研究,术前获得测量值,然后在术后6周、3、6、9和12个月重复测量。术后12个月观察到康复对ODI的影响为-2.7(95%CI:-6.8至1.5),小册子的影响为2.7(95%CI:-1.5至6.9)。这项研究发现,这两种干预措施对长期结果都没有显着影响。
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.