Department of Health Sciences, Faculty of Earth and Life Sciences, VU University Amsterdam; the EMGO+ Institute for Health and Care Research, Amsterdam.
Department of Health Sciences, Faculty of Earth and Life Sciences, VU University Amsterdam; the EMGO+ Institute for Health and Care Research, Amsterdam; Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam.
J Physiother. 2017 Jul;63(3):144-153. doi: 10.1016/j.jphys.2017.05.016. Epub 2017 Jun 28.
Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective compared to no referral?
Multicentre, randomised, controlled trial, and economic evaluation with concealed allocation and intention-to-treat-analysis.
Adults who underwent discectomy for a herniated lumbar disc, confirmed by magnetic resonance imaging, and signs of nerve root compression corresponding to the herniation level.
Early rehabilitation (exercise therapy) for 6 to 8 weeks, versus no referral, immediately after discharge.
In line with the recommended core outcome set, the co-primary outcomes were: functional status (Oswestry Disability Index); leg and back pain (numerical rating scale 0 to 10); global perceived recovery (7-point Likert scale); and general physical and mental health (SF12), assessed 3, 6, 9, 12 and 26 weeks after surgery. The outcomes for the economic evaluation were quality of life and costs, measured at 6, 12 and 26 weeks after surgery.
There were no clinically relevant or statistically significant overall mean differences between rehabilitation and control for any outcome adjusted for baseline characteristics: global perceived recovery (OR 1.0, 95% CI 0.6 to 1.7), functional status (MD 1.5, 95% CI -3.6 to 6.7), leg pain (MD 0.1, 95% CI -0.7 to 0.8), back pain (MD 0.3, 95% CI -0.3 to 0.9), physical health (MD -3.5, 95% CI -11.3 to 4.3), and mental health (MD -4.1, 95% CI -9.4 to 1.3). After 26 weeks, there were no significant differences in quality-adjusted life years (MD 0.01, 95% CI -0.02 to 0.04 points) and societal costs (MD -€527, 95% CI -2846 to 1506). The maximum probability for the intervention to be cost-effective was 0.75 at a willingness-to-pay of €32 000/quality-adjusted life year.
Early rehabilitation after lumbar disc surgery was neither more effective nor more cost-effective than no referral.
Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017) Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy 63: 144-153].
与不转诊相比，腰椎间盘手术后早期康复是否更有效且更具成本效益？
多中心、随机对照试验和经济评估，采用隐蔽分组和意向治疗分析。
接受过椎间盘切除术的成年人，经磁共振成像（MRI）证实存在椎间盘突出，并出现与突出水平相对应的神经根受压迹象。
手术后立即出院，进行 6 至 8 周的早期康复（运动疗法），与不转诊相比。
与推荐的核心结局集一致，主要结局为：功能状态（Oswestry 残疾指数）；腿部和背部疼痛（0 至 10 数字评分量表）；整体感知恢复（7 点 Likert 量表）；以及一般身体和心理健康（SF12），在手术后 3、6、9、12 和 26 周进行评估。经济评估的结局是生活质量和成本，在手术后 6、12 和 26 周进行测量。
在调整基线特征后，对于任何调整后的结局，康复组与对照组之间均无临床相关或统计学显著的总体平均差异：整体感知恢复（OR 1.0，95%CI 0.6 至 1.7）；功能状态（MD 1.5，95%CI -3.6 至 6.7）；腿部疼痛（MD 0.1，95%CI -0.7 至 0.8）；背部疼痛（MD 0.3，95%CI -0.3 至 0.9）；身体健康（MD -3.5，95%CI -11.3 至 4.3）；心理健康（MD -4.1，95%CI -9.4 至 1.3）。26 周后，在质量调整生命年（MD 0.01，95%CI -0.02 至 0.04 分）和社会成本（MD -€527，95%CI -2846 至 1506）方面均无显著差异。在支付意愿为 32000 欧元/质量调整生命年时，干预措施具有成本效益的最大概率为 0.75。
与不转诊相比，腰椎间盘手术后的早期康复既没有更有效，也没有更具成本效益。
荷兰试验注册处 NTR3156。[Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017) 与不转诊相比，腰椎间盘手术后的早期康复既不更有效也不更具成本效益：一项随机试验和经济评估。《物理治疗杂志》63: 144-153]。
