De Hoogstraat Revalidatie/Kenniscentrum Revalidatiegeneeskunde Utrecht Rembrandtkade 10, Utrecht, 3583 TM, The Netherlands.
Department of Epidemiology and Data Science, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands.
BMC Med. 2024 Oct 23;22(1):484. doi: 10.1186/s12916-024-03679-3.
Low back pain is the leading cause of global disability for which exercise therapy is a widely recommended treatment. Research indicates that contextual factors may also influence treatment outcomes in low back pain. Examples include the patient-therapist relationship and other treatment-related circumstances that affect patient expectations. By focusing on the specific treatment effect, clinical trials often ignore the effect of contextual factors, thereby contributing to the so-called efficacy paradox. This means that treatment effects observed in clinical practice are often greater than those reported in clinical trials. This systematic review aims to investigate the proportion of improvement in pain and disability that can be attributed to contextual effects in the outcome of exercise therapy for patients with low back pain.
A meta-analysis was conducted. PubMed, Embase, and the Cochrane database were searched for eligible articles reporting randomized controlled trials that compared exercise therapy to placebo interventions. Risk of bias was assessed with the Revised Cochrane Risk of Bias Tool. Outcomes of interest were pain and disability. Meta-analysis was carried out to calculate the proportion attributable to contextual effects for both pain and disability. The body of evidence was assessed using the GRADE methodology.
Eight studies met the inclusion criteria and were included in the meta-analysis. Five studies were rated as having a moderate risk of bias and two studies had a low risk of bias. Proportion attributable to contextual effects was 0.60 (95% CI 0.40-0.89) for pain and 0.69 (95% CI 0.48-1.00) for disability. Certainty of the evidence as assessed with the GRADE methodology was low.
A large extent of pain and disability improvement after exercise therapy in low back pain is attributable to contextual effects although this conclusion is based on low certainty evidence.
腰痛是导致全球残疾的主要原因，运动疗法是广泛推荐的治疗方法。研究表明，背景因素也可能影响腰痛的治疗效果。例如，医患关系和其他影响患者期望的治疗相关情况。通过关注特定的治疗效果，临床试验往往忽略了背景因素的影响，从而导致所谓的疗效悖论。这意味着在临床实践中观察到的治疗效果往往大于临床试验报告的效果。本系统评价旨在调查腰痛患者运动疗法的结果中，可归因于背景效应的疼痛和残疾改善比例。
进行了荟萃分析。检索 PubMed、Embase 和 Cochrane 数据库，以查找报告比较运动疗法与安慰剂干预的随机对照试验的合格文章。使用修订后的 Cochrane 偏倚风险工具评估偏倚风险。感兴趣的结局是疼痛和残疾。进行荟萃分析以计算疼痛和残疾的背景效应归因比例。使用 GRADE 方法评估证据体。
八项研究符合纳入标准并纳入荟萃分析。五项研究被评为中度偏倚风险，两项研究为低偏倚风险。疼痛的归因比例为 0.60（95%CI 0.40-0.89），残疾的归因比例为 0.69（95%CI 0.48-1.00）。使用 GRADE 方法评估证据确定性为低。
尽管这一结论基于低确定性证据，但腰痛患者在接受运动疗法后，很大程度上的疼痛和残疾改善归因于背景效应。
