Fairbank Jeremy, Frost Helen, Wilson-MacDonald James, Yu Ly-Mee, Barker Karen, Collins Rory
Nuffield Orthopaedic Centre, Oxford OX3 7LD.
BMJ. 2005 May 28;330(7502):1233. doi: 10.1136/bmj.38441.620417.8F. Epub 2005 May 23.
To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain.
Multicentre randomised controlled trial.
15 secondary care orthopaedic and rehabilitation centres across the United Kingdom.
349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion.
Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy.
The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure.
176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was -4.1 (95% confidence interval -8.1 to -0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures.
Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.
评估手术稳定治疗（脊柱融合术）与强化康复治疗对慢性下腰痛患者的临床疗效。
多中心随机对照试验。
英国15个二级护理骨科和康复中心。
349名年龄在18至55岁之间、患有至少一年慢性下腰痛且被认为适合脊柱融合术的患者。
腰椎融合术或基于认知行为疗法原则的强化康复计划。
主要结局指标为随机分组时及随机分组两年后的Oswestry功能障碍指数和往返步行试验。SF-36量表用作次要结局指标。
176名参与者被分配接受手术，173名接受康复治疗。284名（81%）在24个月时提供了随访数据。手术组的Oswestry功能障碍指数平均从46.5（标准差14.6）改善至34.0（标准差21.1），康复组从44.8（标准差14.8）改善至36.1（标准差20.6）。两组之间的估计平均差异为-4.1（95%置信区间-8.1至-0.1，P = 0.045），有利于手术组。在往返步行试验或任何其他结局指标中，未观察到治疗组之间存在显著差异。
两组在两年随访期间均报告功能障碍有所减轻，这可能与干预措施无关。两个主要结局指标之一中治疗组之间的统计学差异很小，仅刚刚达到预先定义的最小临床差异，同时还需要考虑手术的潜在风险和额外费用。没有明确证据表明初次脊柱融合手术比强化康复更有益。
