Page Matthew J, Green Sally, Kramer Sharon, Johnston Renea V, McBain Brodwen, Chau Marisa, Buchbinder Rachelle
School of Public Health & Preventive Medicine, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, Victoria, Australia, 3004.
Cochrane Database Syst Rev. 2014 Aug 26;2014(8):CD011275. doi: 10.1002/14651858.CD011275.
Adhesive capsulitis (also termed frozen shoulder) is commonly treated by manual therapy and exercise, usually delivered together as components of a physical therapy intervention. This review is one of a series of reviews that form an update of the Cochrane review, 'Physiotherapy interventions for shoulder pain.'
To synthesise available evidence regarding the benefits and harms of manual therapy and exercise, alone or in combination, for the treatment of patients with adhesive capsulitis.
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL Plus, ClinicalTrials.gov and the WHO ICTRP clinical trials registries up to May 2013, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials, to identify potentially relevant trials.
We included randomised controlled trials (RCTs) and quasi-randomised trials, including adults with adhesive capsulitis, and comparing any manual therapy or exercise intervention versus placebo, no intervention, a different type of manual therapy or exercise or any other intervention. Interventions included mobilisation, manipulation and supervised or home exercise, delivered alone or in combination. Trials investigating the primary or adjunct effect of a combination of manual therapy and exercise were the main comparisons of interest. Main outcomes of interest were participant-reported pain relief of 30% or greater, overall pain (mean or mean change), function, global assessment of treatment success, active shoulder abduction, quality of life and the number of participants experiencing adverse events.
Two review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment and assessed the quality of the body of evidence for the main outcomes using the GRADE approach.
We included 32 trials (1836 participants). No trial compared a combination of manual therapy and exercise versus placebo or no intervention. Seven trials compared a combination of manual therapy and exercise versus other interventions but were clinically heterogeneous, so opportunities for meta-analysis were limited. The overall impression gained from these trials is that the few outcome differences between interventions that were clinically important were detected only up to seven weeks. Evidence of moderate quality shows that a combination of manual therapy and exercise for six weeks probably results in less improvement at seven weeks but a similar number of adverse events compared with glucocorticoid injection. The mean change in pain with glucocorticoid injection was 58 points on a 100-point scale, and 32 points with manual therapy and exercise (mean difference (MD) 26 points, 95% confidence interval (CI) 15 points to 37 points; one RCT, 107 participants), for an absolute difference of 26% (15% to 37%). Mean change in function with glucocorticoid injection was 39 points on a 100-point scale, and 14 points with manual therapy and exercise (MD 25 points, 95% CI 35 points to 15 points; one RCT, 107 participants), for an absolute difference of 25% (15% to 35%). Forty-six per cent (26/56) of participants reported treatment success with manual therapy and exercise compared with 77% (40/52) of participants receiving glucocorticoid injection (risk ratio (RR) 0.6, 95% CI 0.44 to 0.83; one RCT, 108 participants), with an absolute risk difference of 30% (13% to 48%). The number reporting adverse events did not differ between groups: 56% (32/57) reported events with manual therapy and exercise, and 53% (30/57) with glucocorticoid injection (RR 1.07, 95% CI 0.76 to 1.49; one RCT, 114 participants), with an absolute risk difference of 4% (-15% to 22%). Group differences in improvement in overall pain and function at six months and 12 months were not clinically important.We are uncertain of the effect of other combinations of manual therapy and exercise, as most evidence is of low quality. Meta-analysis of two trials (86 participants) suggested no clinically important differences between a combination of manual therapy, exercise, and electrotherapy for four weeks and placebo injection compared with glucocorticoid injection alone or placebo injection alone in terms of overall pain, function, active range of motion and quality of life at six weeks, six months and 12 months (though the 95% CI suggested function may be better with glucocorticoid injection at six weeks). The same two trials found that adding a combination of manual therapy, exercise and electrotherapy for four weeks to glucocorticoid injection did not confer clinically important benefits over glucocorticoid injection alone at each time point. Based on one high quality trial (148 participants), following arthrographic joint distension with glucocorticoid and saline, a combination of manual therapy and supervised exercise for six weeks conferred similar effects to those of sham ultrasound in terms of overall pain, function and quality of life at six weeks and at six months, but provided greater patient-reported treatment success and active shoulder abduction at six weeks. One trial (119 participants) found that a combination of manual therapy, exercise, electrotherapy and oral non-steroidal anti-inflammatory drug (NSAID) for three weeks did not confer clinically important benefits over oral NSAID alone in terms of function and patient-reported treatment success at three weeks.On the basis of 25 clinically heterogeneous trials, we are uncertain of the effect of manual therapy or exercise when not delivered together, or one type of manual therapy or exercise versus another, as most reported differences between groups were not clinically or statistically significant, and the evidence is mostly of low quality.
AUTHORS' CONCLUSIONS: The best available data show that a combination of manual therapy and exercise may not be as effective as glucocorticoid injection in the short-term. It is unclear whether a combination of manual therapy, exercise and electrotherapy is an effective adjunct to glucocorticoid injection or oral NSAID. Following arthrographic joint distension with glucocorticoid and saline, manual therapy and exercise may confer effects similar to those of sham ultrasound in terms of overall pain, function and quality of life, but may provide greater patient-reported treatment success and active range of motion. High-quality RCTs are needed to establish the benefits and harms of manual therapy and exercise interventions that reflect actual practice, compared with placebo, no intervention and active interventions with evidence of benefit (e.g. glucocorticoid injection).
粘连性关节囊炎（又称肩周炎）通常采用手法治疗和运动疗法进行治疗，这两种疗法通常作为物理治疗干预的组成部分同时实施。本综述是一系列对Cochrane综述“肩部疼痛的物理治疗干预措施”进行更新的综述之一。
综合关于手法治疗和运动疗法单独或联合使用治疗粘连性关节囊炎患者的益处和危害的现有证据。
我们检索了Cochrane对照试验中央注册库、MEDLINE、EMBASE、CINAHL Plus、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台，检索截至2013年5月的试验，不受语言限制，并查阅了综述文章和检索到的试验的参考文献列表，以识别潜在相关试验。
我们纳入了随机对照试验（RCT）和半随机试验，受试对象为患有粘连性关节囊炎的成年人，比较任何手法治疗或运动疗法与安慰剂、无干预、不同类型的手法治疗或运动疗法或任何其他干预措施。干预措施包括松动术、整复手法以及监督下的运动或家庭运动，可单独或联合实施。研究手法治疗和运动疗法联合使用的主要或辅助效果的试验是主要的关注比较对象。主要关注的结局包括受试者报告疼痛缓解30%或更多、总体疼痛（均值或均值变化）、功能、治疗成功的总体评估、主动肩关节外展、生活质量以及发生不良事件的受试者数量。
两位综述作者独立选择纳入试验，提取数据，进行偏倚风险评估，并使用GRADE方法评估主要结局的证据质量。
我们纳入了32项试验（1836名受试者）。没有试验比较手法治疗和运动疗法联合使用与安慰剂或无干预措施的效果。7项试验比较了手法治疗和运动疗法联合使用与其他干预措施，但临床异质性较大，因此荟萃分析的机会有限。从这些试验中得到的总体印象是，仅在长达7周的时间内检测到了干预措施之间在临床上重要的少数结局差异。中等质量的证据表明，与糖皮质激素注射相比，手法治疗和运动疗法联合使用6周可能在7周时改善程度较小，但不良事件数量相似。糖皮质激素注射组疼痛的平均变化在100分制上为58分，手法治疗和运动疗法组为32分（平均差值（MD）26分，95%置信区间（CI）15分至37分；1项RCT，107名受试者），绝对差值为26%（15%至37%）。糖皮质激素注射组功能的平均变化在100分制上为39分，手法治疗和运动疗法组为14分（MD 25分，95%CI 35分至15分；1项RCT，107名受试者），绝对差值为25%（15%至35%）。46%（26/56）的受试者报告手法治疗和运动疗法治疗成功，而接受糖皮质激素注射的受试者中这一比例为77%（40/52）（风险比（RR）0.6，95%CI 0.44至0.83；1项RCT，108名受试者），绝对风险差值为30%（13%至48%）。两组报告不良事件的人数没有差异：56%（32/57）的受试者报告手法治疗和运动疗法组发生不良事件，53%（30/57）的受试者报告糖皮质激素注射组发生不良事件（RR 1.07，95%CI 0.76至1.49；1项RCT，114名受试者），绝对风险差值为4%（-15%至22%）。6个月和12个月时总体疼痛和功能改善的组间差异在临床上并不重要。我们不确定手法治疗和运动疗法的其他联合方式的效果，因为大多数证据质量较低。对两项试验（86名受试者）的荟萃分析表明，手法治疗、运动疗法和电疗法联合使用4周与单独使用糖皮质激素注射或单独使用安慰剂注射相比，在6周、6个月和一年时的总体疼痛、功能、主动活动范围和生活质量方面没有临床上重要的差异（尽管95%CI表明6周时糖皮质激素注射组的功能可能更好）。同样的两项试验发现，在糖皮质激素注射基础上增加手法治疗、运动疗法和电疗法联合使用4周，在每个时间点与单独使用糖皮质激素注射相比并没有带来临床上重要的益处。基于一项高质量试验（148名受试者），在关节造影关节扩张并注射糖皮质激素和生理盐水后，手法治疗和监督下的运动疗法联合使用6周在6周和6个月时的总体疼痛、功能和生活质量方面与假超声的效果相似，但在6周时患者报告的治疗成功率更高，主动肩关节外展范围更大。一项试验（119名受试者）发现，手法治疗、运动疗法、电疗法和口服非甾体抗炎药（NSAID）联合使用3周与单独口服NSAID相比，在3周时的功能和患者报告的治疗成功率方面没有带来临床上重要的益处。基于25项临床异质性试验，我们不确定不联合使用时手法治疗或运动疗法的效果，也不确定一种手法治疗或运动疗法与另一种相比的效果，因为大多数组间差异在临床或统计学上不显著，且证据大多质量较低。
现有最佳数据表明，手法治疗和运动疗法联合使用在短期内可能不如糖皮质激素注射有效。尚不清楚手法治疗、运动疗法和电疗法联合使用是否是糖皮质激素注射或口服NSAID的有效辅助治疗方法。在关节造影关节扩张并注射糖皮质激素和生理盐水后，手法治疗和运动疗法在总体疼痛、功能和生活质量方面可能与假超声的效果相似，但可能带来更高的患者报告治疗成功率和更大的主动活动范围。需要高质量的RCT来确定与安慰剂、无干预以及有获益证据的积极干预措施（如糖皮质激素注射）相比，反映实际临床实践的手法治疗和运动疗法干预措施的益处和危害。
