Department of Health Sciences, Faculty of Science and Amsterdam Movement Sciences Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Cochrane Database Syst Rev. 2023 Aug 30;8(8):CD009365. doi: 10.1002/14651858.CD009365.pub2.
Low back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide.
To evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up.
This is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004.
We included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment.
We used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome.
We included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group. We downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants). There is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity. In two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.
AUTHORS' CONCLUSIONS: Exercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).
腰痛（LBP）是全球导致残疾的主要原因。它会产生相当大的直接成本（医疗保健）和间接成本（生产力损失）。许多可用于治疗 LBP 的方法包括运动疗法，该疗法在全球范围内广泛应用。
评估急性非特异性 LBP 成人患者接受运动疗法与假/安慰剂治疗或不治疗相比，在短期、中期和长期随访时的疗效和安全性。
这是 Cochrane 综述的更新版本，首次发表于 2005 年。我们更新了对随机对照试验（RCT）的检索，检索了 CENTRAL、MEDLINE、Embase、其他四个数据库和两个试验登记处。我们还筛选了所有纳入研究的参考文献列表和自 2004 年以来发表的相关系统评价。
我们纳入了研究运动疗法对非特异性 LBP 持续 6 周或更短时间的成年人的影响的 RCT。主要结局为疼痛、功能状态和感知恢复。次要结局为恢复工作、健康相关生活质量和不良事件。我们的主要比较是运动疗法与假/安慰剂治疗和运动疗法与不治疗。
我们使用标准的 Cochrane 方法。我们在短期随访（随机分组后三个月内且最接近六周的时间点；主要随访）、中期随访（9 个月至最接近 6 个月）和长期随访（9 个月后且最接近 12 个月）评估结局，并使用 GRADE 评估每个结局的证据确定性。
我们纳入了 23 项研究（13 项来自之前的综述，10 项新研究），涉及 2674 名参与者，其中 2637 名参与者提供了数据。3 项小型研究正在等待分类，4 项合格研究正在进行中。纳入的研究在欧洲（n=9）、亚太地区（n=9）和北美（n=5）进行；大多数研究在初级保健环境（n=12）、二级保健环境（n=6）或两者（n=1）中进行。大多数研究的参与者年龄在中年，包括男性和女性。我们认为 10 项研究（43%）在随机序列和分配隐藏方面的偏倚风险较低。在运动疗法中，由于无法实施盲法，存在表现和检测偏倚。与假/安慰剂治疗相比，运动疗法在短期（平均差值（MD）-0.80，95%置信区间（CI）-5.79 至 4.19；1 项研究，299 名参与者）对疼痛评分无临床相关影响的证据为极低确定性。绝对差值为疼痛减少 1%（95% CI 4%更多至 6%更少），相对差值为疼痛减少 4%（95% CI 20%更多至 28%更少）。干预组的平均疼痛评分为 20.1（标准差（SD）21），对照组为 20.9（SD 23）。与假/安慰剂治疗相比，运动疗法在短期（MD 2.00，95% CI -2.20 至 6.20；1 项研究，299 名参与者）对功能状态评分无临床相关影响的证据为极低确定性。绝对差值为功能状态差 2%（95% CI 2%更好至 6%更差），相对差值为功能状态差 15%（95% CI 17%更好至 47%更差）。干预组的平均功能状态评分为 15.3（SD 19），对照组为 13.3（SD 18）。我们将疼痛和功能状态的证据确定性因偏倚风险降低一级，因不精确性降低两级。只有一项研究（n=157）有少于 400 名参与者，因此我们将其证据确定性进一步降级。与不治疗相比，运动疗法在短期（2 项研究，157 名参与者）对疼痛或功能状态无临床相关影响的证据为极低确定性。我们将证据确定性因不精确性降低两级，因不一致性降低一级。一项研究发现运动疗法有较小的益处，另一项研究则没有发现差异。第一项研究在职业保健中心进行，参与者接受一次运动疗法治疗。另一项研究在二级和三级保健环境中进行，参与者每周接受三次治疗，为期六周。由于临床异质性较大，我们未对这些研究进行数据合并。在两项研究中，没有报告不良事件。一项研究报告了与运动疗法无关的不良事件。其余研究没有报告是否发生了任何不良事件。由于不良事件报告不足，我们无法得出关于运动疗法安全性或危害的任何结论。
与假/安慰剂治疗相比，急性非特异性 LBP 成人患者接受运动疗法在短期内可能对疼痛或功能状态无临床相关影响，但证据非常不确定。与不治疗相比，急性非特异性 LBP 成人患者接受运动疗法在短期内可能对疼痛或功能状态无临床相关影响，但证据非常不确定。我们将证据确定性降级为非常低，因为存在不一致性、偏倚风险和不精确性（参与者少）。
