Smith Toby O, Drew Benjamin T, Meek Toby H, Clark Allan B
Faculty of Medicine and Health Sciences, University of East Anglia, Queen's Building, Norwich, Norfolk, UK, NR4 7TJ.
Cochrane Database Syst Rev. 2015 Dec 8;2015(12):CD010513. doi: 10.1002/14651858.CD010513.pub2.
Patellofemoral pain syndrome (PFPS) is a painful musculoskeletal condition, which is characterised by knee pain located in the anterior aspect (front) and retropatellar region (behind) of the knee joint. Various non-operative interventions are suggested for the treatment of this condition. Knee orthoses (knee braces, sleeves, straps or bandages) are worn over the knee and are thought to help reduce knee pain. They can be used in isolation or in addition to other treatments such as exercise or non-steroidal anti-inflammatory medications.
To assess the effects (benefits and harms) of knee orthoses (knee braces, sleeves, straps or bandages) for treating PFPS.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (11 May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015 Issue 5), MEDLINE (1946 to 8 May 2015), EMBASE (1980 to 2015 Week 18), SPORTDiscus (1985 to 11 May 2015), AMED (1985 to 8 May 2015), CINAHL (1937 to 11 May 2015), PEDro (1929 to June 2015), trial registries and conference proceedings.
Randomised and quasi-randomised controlled clinical trials evaluating knee orthoses for treating people with PFPS. Our primary outcomes were pain and function.
Two review authors independently assessed studies for eligibility, assessed study risk of bias and extracted data. We calculated mean differences (MD) or, where pooling data from different scales, standardised mean differences (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CIs for binary outcomes. We pooled data using the fixed-effect model.
We included five trials (one of which was quasi-randomised) that reported results for 368 people who had PFPS. Participants were recruited from health clinics in three trials and were military recruits undergoing training in the other two trials. Although no trials recruited participants who were categorised as elite or professional athletes, military training does comprise intensive exercise regimens. All five trials were at high risk of bias, including performance bias reflecting the logistical problems in these trials of blinding of participants and care providers. As assessed using the GRADE approach, the available evidence for all reported outcomes is 'very low' quality. This means that we are very uncertain about the results.The trials covered three different types of comparison: knee orthosis and exercises versus exercises alone; one type of orthosis versus another; and knee orthosis versus exercises. No trials assessed the mode of knee orthosis use, such as whether the orthosis was worn all day or only during physical activity. Two trials had two groups; two trials had three groups; and one trial had four groups.All five trials compared a knee orthosis (knee sleeve, knee brace, or patellar strap) versus a 'no treatment' control group, with all participants receiving exercises, either through a military training programme or a home-based exercise programme. There is very low quality evidence of no clinically important differences between the two groups in short-term (2 to 12 weeks follow-up) knee pain based on the visual analogue scale (0 to 10 points; higher scores mean worse pain): MD -0.46 favouring knee orthoses, 95% CI -1.16 to 0.24; P = 0.19; 234 participants, 3 trials). A similar lack of clinically important difference was found for knee function (183 participants, 2 trials). None of the trials reported on quality of life measures, resource use or participant satisfaction. Although two trials reported on the impact on sporting or occupational participation, one trial (35 participants) did not provide data split by treatment group on the resumption of sport activity and the other reported only on abandonment of military training due to knee pain (both cases were allocated a knee orthosis). One trial (59 participants, 84 affected knees) recording only adverse events in the two knee orthoses (both were knee sleeves) groups, reported 16 knees (36% of 44 knees) had discomfort or skin abrasion.Three trials provided very low quality evidence on single comparisons of different types of knee orthoses: a knee brace versus a knee sleeve (63 participants), a patella strap with a knee sleeve (31 participants), and a knee sleeve with a patellar ring versus a knee sleeve only (44 knees). None of three trials found an important difference between the two types of knee orthosis in pain. One trial found no clinically important difference in function between a knee brace and a knee sleeve. None of the three trials reported on quality of life, resource use or participant satisfaction. One trial comparing a patella strap with a knee sleeve reported that both participants quitting military training due to knee pain were allocated a knee sleeve. One poorly reported trial found three times as many knees with adverse effects (discomfort or skin abrasion) in those given knee sleeves with a patella ring than those given knee sleeves only.One trial compared a knee orthosis (knee brace) with exercise (66 participants). It found very low quality evidence of no clinically important difference between the two intervention groups in pain or knee function. The trial did not report on quality of life, impact on sporting or occupational participation, resource use, participant satisfaction or complications.
AUTHORS' CONCLUSIONS: Overall, this review has found a lack of evidence to inform on the use of knee orthoses for treating PFPS. There is, however, very low quality evidence from clinically heterogeneous trials using different types of knee orthoses (knee brace, sleeve and strap) that using a knee orthosis did not reduce knee pain or improve knee function in the short term (under three months) in adults who were also undergoing an exercise programme for treating PFPS. This points to the need for good-quality clinically-relevant research to inform on the use of commonly-available knee orthoses for treating PFPS.
髌股疼痛综合征（PFPS）是一种引起疼痛的肌肉骨骼疾病，其特征为膝关节前侧（前方）和髌后区域（后方）疼痛。针对该疾病的治疗，建议采用多种非手术干预措施。膝关节矫形器（护膝、护腿套、束带或绷带）穿戴于膝关节上，被认为有助于减轻膝关节疼痛。它们可单独使用，也可作为运动或非甾体类抗炎药物等其他治疗的辅助手段。
评估膝关节矫形器（护膝、护腿套、束带或绷带）治疗PFPS的效果（益处和危害）。
我们检索了Cochrane骨、关节与肌肉创伤专业组专门注册库（2015年5月11日）、Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2015年第5期）、MEDLINE（1946年至2015年5月8日）、EMBASE（1980年至2015年第18周）、SPORTDiscus（1985年至2015年5月11日）、AMED（1985年至2015年5月8日）、CINAHL（1937年至2015年5月11日）、PEDro（1929年至2015年6月）、试验注册库和会议论文集。
评估膝关节矫形器治疗PFPS患者的随机和半随机对照临床试验。我们的主要结局指标为疼痛和功能。
两位综述作者独立评估研究的入选资格、评估研究的偏倚风险并提取数据。对于连续性结局，我们计算了平均差（MD），或者在合并来自不同量表的数据时，计算标准化平均差（SMD）及其95%置信区间（CI）；对于二分法结局，计算风险比（RR）及其95%CI。我们使用固定效应模型合并数据。
我们纳入了五项试验（其中一项为半随机试验），这些试验报告了368例PFPS患者的结果。三项试验的参与者来自健康诊所，另外两项试验的参与者为正在接受训练的新兵。尽管没有试验招募被归类为精英或职业运动员的参与者，但军事训练确实包含高强度的运动方案。所有五项试验均存在较高的偏倚风险，包括表现偏倚，这反映了这些试验中参与者和护理人员设盲方面的后勤问题。使用GRADE方法评估，所有报告结局的现有证据质量均为“极低”。这意味着我们对结果非常不确定。这些试验涵盖了三种不同类型的比较：膝关节矫形器与运动对比单纯运动；一种矫形器与另一种矫形器对比；膝关节矫形器与运动对比。没有试验评估膝关节矫形器的使用方式，例如矫形器是全天佩戴还是仅在体育活动期间佩戴。两项试验有两个组；两项试验有三个组；一项试验有四个组。所有五项试验均将膝关节矫形器（护膝、护腿套或髌带）与“无治疗”对照组进行了比较，所有参与者均通过军事训练计划或家庭锻炼计划接受运动。基于视觉模拟量表（0至10分；分数越高疼痛越严重），有极低质量的证据表明两组在短期（随访2至12周）膝关节疼痛方面无临床重要差异：MD为-0.46，支持膝关节矫形器，95%CI为-1.16至0.24；P = 0.19；234名参与者，3项试验）。在膝关节功能方面也发现了类似的缺乏临床重要差异的情况（183名参与者，2项试验）。没有试验报告生活质量指标、资源使用情况或参与者满意度。尽管两项试验报告了对体育或职业参与的影响，但一项试验（35名参与者）未提供按治疗组划分的恢复体育活动的数据，另一项试验仅报告了因膝关节疼痛而放弃军事训练的情况（这两种情况均分配了膝关节矫形器）。一项试验（59名参与者，84个患膝）仅记录了两个膝关节矫形器（均为护膝）组中的不良事件，报告称16个膝关节（44个膝关节中的36%）出现不适或皮肤擦伤。三项试验提供了关于不同类型膝关节矫形器单一比较的极低质量证据：护膝与护腿套对比（63名参与者）、髌带与护膝对比（31名参与者）、带髌环的护膝与仅护膝对比（44个膝关节）。三项试验均未发现两种类型的膝关节矫形器在疼痛方面有重要差异。一项试验发现护膝与护腿套在功能方面无临床重要差异。三项试验均未报告生活质量、资源使用情况或参与者满意度。一项比较髌带与护膝的试验报告称，两名因膝关节疼痛而退出军事训练的参与者均被分配了护膝。一项报告不佳的试验发现，佩戴带髌环护膝的膝关节出现不良反应（不适或皮肤擦伤）的数量是仅佩戴护膝者膝关节的三倍。一项试验将膝关节矫形器（护膝）与运动进行了对比（66名参与者）。它发现极低质量的证据表明两个干预组在疼痛或膝关节功能方面无临床重要差异。该试验未报告生活质量、对体育或职业参与的影响、资源使用情况、参与者满意度或并发症。
总体而言，本综述发现缺乏证据来指导膝关节矫形器用于治疗PFPS的应用。然而，来自使用不同类型膝关节矫形器（护膝、护腿套和束带）的临床异质性试验的极低质量证据表明，对于正在接受PFPS治疗运动计划的成年人，在短期内（三个月以内）使用膝关节矫形器并不能减轻膝关节疼痛或改善膝关节功能。这表明需要开展高质量的临床相关研究，以指导常用膝关节矫形器用于治疗PFPS的应用。
