Department of Community Health & Epidemiology, Dalhousie University, Halifax, Canada.
Centre for Health and Social Economics (CHESS), National Institute for Health and Welfare (THL), Helsinki, Finland.
Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
Low back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs.
The primary objective of this systematic review is to assess the impact of exercise treatment on pain and functional limitations in adults with chronic non-specific low back pain compared to no treatment, usual care, placebo and other conservative treatments.
We searched CENTRAL (which includes the Cochrane Back and Neck trials register), MEDLINE, Embase, CINAHL, PsycINFO, PEDro, SPORTDiscus, and trials registries (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform), and conducted citation searching of relevant systematic reviews to identify additional studies. The review includes data for trials identified in searches up to 27 April 2018. All eligible trials have been identified through searches to 7 December 2020, but have not yet been extracted; these trials will be integrated in the next update.
We included randomised controlled trials that assessed exercise treatment compared to no treatment, usual care, placebo or other conservative treatment on the outcomes of pain or functional limitations for a population of adult participants with chronic non-specific low back pain of more than 12 weeks' duration.
Two authors screened and assessed studies independently, with consensus. We extracted outcome data using electronic databases; pain and functional limitations outcomes were re-scaled to 0 to 100 points for meta-analyses where 0 is no pain or functional limitations. We assessed risk of bias using the Cochrane risk of bias (RoB) tool and used GRADE to evaluate the overall certainty of the evidence. When required, we contacted study authors to obtain missing data. To interpret meta-analysis results, we considered a 15-point difference in pain and a 10-point difference in functional limitations outcomes to be clinically important for the primary comparison of exercise versus no treatment, usual care or placebo.
We included 249 trials of exercise treatment, including studies conducted in Europe (122 studies), Asia (38 studies), North America (33 studies), and the Middle East (24 studies). Sixty-one per cent of studies (151 trials) examined the effectiveness of two or more different types of exercise treatment, and 57% (142 trials) compared exercise treatment to a non-exercise comparison treatment. Study participants had a mean age of 43.7 years and, on average, 59% of study populations were female. Most of the trials were judged to be at risk of bias, including 79% at risk of performance bias due to difficulty blinding exercise treatments. We found moderate-certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or placebo comparisons for pain outcomes at earliest follow-up (MD -15.2, 95% CI -18.3 to -12.2), a clinically important difference. Certainty of evidence was downgraded mainly due to heterogeneity. For the same comparison, there was moderate-certainty evidence for functional limitations outcomes (MD -6.8 (95% CI -8.3 to -5.3); this finding did not meet our prespecified threshold for minimal clinically important difference. Certainty of evidence was downgraded mainly due to some evidence of publication bias. Compared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) and functional limitations outcomes (MD -4.1, 95% CI -6.0 to -2.2). These effects did not meet our prespecified threshold for clinically important difference. Subgroup analysis of pain outcomes suggested that exercise treatment is probably more effective than education alone (MD -12.2, 95% CI -19.4 to -5.0) or non-exercise physical therapy (MD -10.4, 95% CI -15.2 to -5.6), but with no differences observed for manual therapy (MD 1.0, 95% CI -3.1 to 5.1). In studies that reported adverse effects (86 studies), one or more adverse effects were reported in 37 of 112 exercise groups (33%) and 12 of 42 comparison groups (29%). Twelve included studies reported measuring adverse effects in a systematic way, with a median of 0.14 (IQR 0.01 to 0.57) per participant in the exercise groups (mostly minor harms, e.g. muscle soreness), and 0.12 (IQR 0.02 to 0.32) in comparison groups.
AUTHORS' CONCLUSIONS: We found moderate-certainty evidence that exercise is probably effective for treatment of chronic low back pain compared to no treatment, usual care or placebo for pain. The observed treatment effect for the exercise compared to no treatment, usual care or placebo comparisons is small for functional limitations, not meeting our threshold for minimal clinically important difference. We also found exercise to have improved pain (low-certainty evidence) and functional limitations outcomes (moderate-certainty evidence) compared to other conservative treatments; however, these effects were small and not clinically important when considering all comparisons together. Subgroup analysis suggested that exercise treatment is probably more effective than advice or education alone, or electrotherapy, but with no differences observed for manual therapy treatments.
在过去的三十年中，腰痛一直是全球导致残疾的主要原因，这导致了巨大的直接医疗保健和生产力损失成本。
本系统评价的主要目的是评估运动治疗对慢性非特异性腰痛成年人疼痛和功能限制的影响，与无治疗、常规护理、安慰剂和其他保守治疗相比。
我们检索了 CENTRAL（包括 Cochrane 背部和颈部试验登记册）、MEDLINE、Embase、CINAHL、PsycINFO、PEDro、SPORTDiscus 和试验登记册（ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台），并对相关系统评价进行了引文搜索，以确定其他研究。该综述包括截至 2018 年 4 月 27 日搜索结果的数据。所有符合条件的试验都已通过截至 2020 年 12 月 7 日的搜索确定，但尚未提取；这些试验将在下一次更新中纳入。
我们纳入了随机对照试验，评估了运动治疗与无治疗、常规护理、安慰剂或其他保守治疗在慢性非特异性腰痛持续 12 周以上的成年患者疼痛或功能限制结局方面的比较。
两名作者独立筛选和评估研究，达成共识。我们使用电子数据库提取结局数据；疼痛和功能限制结局以 0 到 100 点进行重新缩放，以便对运动与无治疗、常规护理或安慰剂的主要比较进行 meta 分析，其中 0 表示无疼痛或功能限制。我们使用 Cochrane 偏倚风险工具（RoB 工具）评估偏倚风险，并使用 GRADE 评估证据的总体确定性。当需要时，我们联系研究作者以获取缺失数据。为了解释 meta 分析结果，如果与无治疗、常规护理或安慰剂的主要比较中，疼痛差异为 15 点，功能限制差异为 10 点，则认为运动治疗的效果具有临床意义。
我们纳入了 249 项运动治疗试验，包括在欧洲（122 项研究）、亚洲（38 项研究）、北美（33 项研究）和中东（24 项研究）进行的研究。61%的研究（151 项试验）检验了两种或两种以上不同类型运动治疗的有效性，57%的研究（142 项试验）将运动治疗与非运动对照治疗进行了比较。研究参与者的平均年龄为 43.7 岁，平均 59%的研究人群为女性。大多数试验被认为存在偏倚风险，包括 79%的试验由于运动治疗难以进行盲法而存在偏倚风险。我们发现，与无治疗、常规护理或安慰剂相比，运动治疗在最早随访时对慢性腰痛的治疗效果更有效，疼痛结局的证据确定性为中等（MD -15.2，95%CI -18.3 至 -12.2），这是一个具有临床意义的差异。证据确定性的降低主要归因于异质性。对于相同的比较，功能限制结局的证据确定性为中等（MD -6.8（95%CI -8.3 至 -5.3）；这一发现没有达到我们预先设定的最小临床重要差异的阈值。证据确定性的降低主要归因于一些存在发表偏倚的证据。与所有其他被调查的保守治疗相比，运动治疗改善了疼痛（MD -9.1，95%CI -12.6 至 -5.6）和功能限制结局（MD -4.1，95%CI -6.0 至 -2.2）。这些效果没有达到我们预先设定的最小临床重要差异的阈值。疼痛结局的亚组分析表明，运动治疗可能比单独教育（MD -12.2，95%CI -19.4 至 -5.0）或非运动物理治疗（MD -10.4，95%CI -15.2 至 -5.6）更有效，但与手动治疗（MD 1.0，95%CI -3.1 至 5.1）无差异。在报告不良反应的 86 项研究中，112 个运动组中有 37 个（33%）和 42 个对照组中的 12 个（29%）报告了一种或多种不良反应。12 项纳入的研究以系统的方式报告了不良反应的测量情况，运动组中每例参与者的中位数为 0.14（IQR 0.01 至 0.57）（大多为轻微伤害，如肌肉酸痛），对照组为 0.12（IQR 0.02 至 0.32）。
我们发现，与无治疗、常规护理或安慰剂相比，运动治疗对慢性腰痛的治疗效果可能更有效，在疼痛方面的证据确定性为中等，而在功能限制方面的证据确定性为低，因为其治疗效果小，没有达到我们预先设定的最小临床重要差异的阈值。我们还发现，与其他保守治疗相比，运动治疗改善了疼痛（低确定性证据）和功能限制结局（中等确定性证据）；然而，这些效果较小，当综合考虑所有比较时，没有临床意义。亚组分析表明，运动治疗可能比单独的建议或教育、电疗更有效，但与手动治疗相比没有差异。
