Brisbane Hand and Upper Limb Research Institute, Brisbane, Australia.
Center for Work, Health and Wellbeing, Harvard TH Chan School of Public Health, Boston, USA.
Cochrane Database Syst Rev. 2021 Jan 13;1(1):CD012479. doi: 10.1002/14651858.CD012479.pub2.
Various rehabilitation treatments may be offered following surgery for flexor tendon injuries of the hand. Rehabilitation often includes a combination of an exercise regimen and an orthosis, plus other rehabilitation treatments, usually delivered together. The effectiveness of these interventions remains unclear.
To assess the effects (benefits and harms) of different rehabilitation interventions after surgery for flexor tendon injuries of the hand.
We searched the Cochrane Central Register of Controlled Trials, the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, MEDLINE, Embase, two additional databases and two international trials registries, unrestricted by language. The last date of searches was 11 August 2020. We checked the reference lists of included studies and relevant systematic reviews.
We included randomised controlled trials (RCTs) and quasi-RCTs that compared any postoperative rehabilitation intervention with no intervention, control, placebo, or another postoperative rehabilitation intervention in individuals who have had surgery for flexor tendon injuries of the hand. Trials comparing different mobilisation regimens either with another mobilisation regimen or with a control were the main comparisons of interest. Our main outcomes of interest were patient-reported function, active range of motion of the fingers, and number of participants experiencing an adverse event.
Two review authors independently selected trials for inclusion, extracted data, assessed risk of bias and assessed the quality of the body of evidence for primary outcomes using the GRADE approach, according to standard Cochrane methodology.
We included 16 RCTs and one quasi-RCT, with a total of 1108 participants, mainly adults. Overall, the participants were aged between 7 and 72 years, and 74% were male. Studies mainly focused on flexor tendon injuries in zone II. The 17 studies were heterogeneous with respect to the types of rehabilitation treatments provided, intensity, duration of treatment and the treatment setting. Each trial tested one of 14 comparisons, eight of which were of different exercise regimens. The other trials examined the timing of return to unrestricted functional activities after surgery (one study); the use of external devices applied to the participant to facilitate mobilisation, such as an exoskeleton (one study) or continuous passive motion device (one study); modalities such as laser therapy (two studies) or ultrasound therapy (one study); and a motor imagery treatment (one study). No trials tested different types of orthoses; different orthosis wearing regimens, including duration; different timings for commencing mobilisation; different types of scar management; or different timings for commencing strengthening. Trials were generally at high risk of bias for one or more domains, including lack of blinding, incomplete outcome data and selective outcome reporting. Data pooling was limited to tendon rupture data in a three trial comparison. We rated the evidence available for all reported outcomes of all comparisons as very low-certainty evidence, which means that we have very little confidence in the estimates of effect. We present the findings from three exercise regimen comparisons, as these are commonly used in clinical current practice. Early active flexion plus controlled passive exercise regimen versus early controlled passive exercise regimen (modified Kleinert protocol) was compared in one trial of 53 participants with mainly zone II flexor tendon repairs. There is very low-certainty evidence of no clinically important difference between the two groups in patient-rated function or active finger range of motion at 6 or 12 months follow-up. There is very low-certainty evidence of little between-group difference in adverse events: there were 15 overall. All three tendon ruptures underwent secondary surgery. An active exercise regimen versus an immobilisation regimen for three weeks was compared in one trial reporting data for 84 participants with zone II flexor tendon repairs. The trial did not report on self-rated function, on range of movement during three to six months or numbers of participants experiencing adverse events. The very low-certainty evidence for poor (under one-quarter that of normal) range of finger movement at one to three years follow-up means we are uncertain of the finding of zero cases in the active group versus seven cases in the immobilisation regimen. The same uncertainty applies to the finding of little difference between the two groups in adverse events (5 tendon ruptures in the active group versus 10 probable scar adhesion in the immobilisation group) indicated for surgery. Place and hold exercise regimen performed within an orthosis versus a controlled passive regimen using rubber band traction was compared in three heterogeneous trials, which reported data for a maximum of 194 participants, with mainly zone II flexor tendon repairs. The trials did not report on range of movement during three to six months, or numbers of participants experiencing adverse events. There was very low-certainty evidence of no difference in self-rated function using the Disability of the Arm, Shoulder and Hand (DASH) functional assessment between the two groups at six months (one trial) or at 12 months (one trial). There is very low-certainty evidence from one trial of greater active finger range of motion at 12 months after place and hold. Secondary surgery data were not available; however, all seven recorded tendon ruptures would have required surgery. All the evidence for the other five exercise comparisons as well as those of the other six comparisons made by the included studies was incomplete and, where available, of very low-certainty.
AUTHORS' CONCLUSIONS: There is a lack of evidence from RCTs on most of the rehabilitation interventions used following surgery for flexor tendon injuries of the hand. The limited and very low-certainty evidence for all 14 comparisons examined in the 17 included studies means that we have very little confidence in the estimates of effect for all outcomes for which data were available for these comparisons. The dearth of evidence identified in this review points to the urgent need for sufficiently powered RCTs that examine key questions relating to the rehabilitation of these injuries. A consensus approach identifying these and establishing minimum study conduct and reporting criteria will be valuable. Our suggestions for future research are detailed in the review.
手部屈肌腱损伤手术后可能会提供各种康复治疗。康复通常包括运动方案和矫形器的结合，以及其他康复治疗，通常一起提供。这些干预措施的效果尚不清楚。
评估手部屈肌腱损伤手术后不同康复干预措施的效果（益处和危害）。
我们检索了 Cochrane 对照试验中心注册库、Cochrane 骨骼、关节和肌肉创伤组专业注册库、MEDLINE、Embase、另外两个数据库和两个国际试验注册库，未对语言进行限制。最后一次检索日期为 2020 年 8 月 11 日。我们检查了纳入研究的参考文献列表和相关系统评价。
我们纳入了比较手部屈肌腱损伤手术后任何术后康复干预与无干预、对照、安慰剂或另一种术后康复干预的随机对照试验（RCT）和准 RCT。我们主要关注的比较是不同的动员方案与另一种动员方案或对照方案的比较。我们主要的结局指标是患者报告的功能、手指的主动活动范围和发生不良事件的参与者人数。
两名综述作者独立选择纳入的试验、提取数据、评估风险偏倚，并根据标准的 Cochrane 方法使用 GRADE 方法评估主要结局的证据质量。
我们纳入了 16 项 RCT 和 1 项准 RCT，共有 1108 名参与者，主要是成年人。总体而言，参与者年龄在 7 至 72 岁之间，74%为男性。研究主要集中在 II 区的屈肌腱损伤。17 项研究在提供的康复治疗类型、强度、治疗持续时间和治疗环境方面存在异质性。每项试验都测试了 14 种比较中的一种，其中 8 种是不同的运动方案。其他试验研究了手术后恢复无限制功能活动的时间（一项研究）；使用外部设备应用于参与者以促进动员，例如外骨骼（一项研究）或连续被动运动设备（一项研究）；激光治疗（两项研究）或超声治疗（一项研究）等治疗方法；以及运动想象治疗（一项研究）。没有试验测试不同类型的矫形器；不同的矫形器佩戴方案，包括持续时间；开始动员的不同时间；不同类型的疤痕管理；或开始强化治疗的不同时间。试验通常在一个或多个领域存在高偏倚风险，包括缺乏盲法、不完整的结局数据和选择性结局报告。在三项试验比较中，仅对肌腱断裂数据进行了数据合并。我们将所有比较的所有报告结局的证据质量评定为极低确定性证据，这意味着我们对效果估计的信心非常有限。我们从三个运动方案比较中呈现结果，因为这些方案在当前临床实践中通常使用。早期主动弯曲加受控被动运动方案与早期受控被动运动方案（改良 Kleinert 方案）比较，一项纳入 53 名主要 II 区屈肌腱修复患者的试验。在 6 或 12 个月的随访中，两组在患者报告的功能或手指主动活动范围方面没有临床意义上的差异，且存在非常低确定性证据。两组之间不良事件的差异存在非常低确定性证据：共有 15 例。所有 3 例肌腱断裂均需再次手术。一项纳入 84 名 II 区屈肌腱修复患者的试验比较了主动运动方案与 3 周的固定方案。该试验未报告自我评估功能、3 至 6 个月期间的活动范围或发生不良事件的参与者人数。在 1 至 3 年随访时手指活动范围较差（低于正常的四分之一）的极低确定性证据意味着我们对主动组零例和固定组 7 例手术的发现不确定。同样的不确定性也适用于两组之间的不良事件（主动组 5 例肌腱断裂与固定组 10 例可能的粘连）的差异。在一项包含最多 194 名参与者的三性试验中，将在矫形器内进行的放置和保持运动方案与使用橡胶带牵引的受控被动方案进行了比较。这些试验未报告 3 至 6 个月期间的活动范围或发生不良事件的参与者人数。在 6 个月（一项试验）或 12 个月（一项试验）时，使用残疾手臂、肩部和手（DASH）功能评估，两组在自我报告的功能方面没有差异，存在非常低确定性证据。在放置和保持 12 个月后，有非常低确定性证据表明手指的主动活动范围更大。次要手术数据不可用；但是，所有记录的 7 例肌腱断裂都需要手术。纳入研究的其他五项运动比较以及其他六项比较的所有其他证据都不完整，而且可用证据的确定性都很低。
手部屈肌腱损伤手术后的大多数康复干预措施都缺乏 RCT 证据。17 项纳入研究中所有 14 项比较的有限且非常低确定性证据意味着，我们对所有可获得这些比较数据的结局的效果估计都没有信心。本综述中确定的证据不足表明，迫切需要足够的 RCT 来检查与这些损伤康复相关的关键问题。确定这些问题并建立最低研究实施和报告标准的共识方法将是有价值的。我们在综述中详细说明了未来研究的建议。
