Abstract：
BACKGROUND: There are several therapeutic options for the management of shoulder adhesive capsulitis (AC). The superiority of arthro-distension over intra-articular steroid injection (ISI) for AC remains controversial.
OBJECTIVE: To evaluate the efficacy of a single arthro-distension procedure combined with early and intensive mobilization (ADM) and physiotherapy, versus ISI and physiotherapy, in people with AC lasting ≥3 months.
METHODS: This was a prospective, 2 parallel-group, 2-center, observer-blind randomized controlled trial conducted in tertiary care settings. Adults with AC were randomly assigned to the treatment or control group. Efficacy was assessed using the self-administered Shoulder Pain and Disability Index (SPADI). Total, pain and disability SPADI scores 15 days, 6 weeks, and 3, 6 and 12 months after the procedure (total SPADI at 15 days: primary outcome; other outcomes were secondary) were compared between groups using analysis of covariance (ANCOVA). A post hoc analysis stratified on the initial range of passive glenohumeral abduction, which had not been pre-specified, was conducted.
RESULTS: There were 33 participants in each group. Both groups improved over time. Mean (SD) total SPADI score at 15 days was 33.8 (19.6) in the treatment group and 32.8 (17.5) in the control group, p = 0.393. There were no significant differences for any variables in the overall sample. The post hoc analysis found ADM to be associated with a significant decrease in total SPADI score at 15 days compared with ISI (p = 0.049) in individuals with initial passive glenohumeral abduction >45°.
CONCLUSIONS: The effects of ADM on pain and function were not statistically different from those of ISI. However, ADM may be useful in individuals with initial passive glenohumeral abduction >45°.
UNASSIGNED: NCT00724113.
OBJECTIVE: To evaluate the efficacy of a single arthro-distension procedure combined with early and intensive mobilization (ADM) and physiotherapy, versus ISI and physiotherapy, in people with AC lasting ≥3 months.
METHODS: This was a prospective, 2 parallel-group, 2-center, observer-blind randomized controlled trial conducted in tertiary care settings. Adults with AC were randomly assigned to the treatment or control group. Efficacy was assessed using the self-administered Shoulder Pain and Disability Index (SPADI). Total, pain and disability SPADI scores 15 days, 6 weeks, and 3, 6 and 12 months after the procedure (total SPADI at 15 days: primary outcome; other outcomes were secondary) were compared between groups using analysis of covariance (ANCOVA). A post hoc analysis stratified on the initial range of passive glenohumeral abduction, which had not been pre-specified, was conducted.
RESULTS: There were 33 participants in each group. Both groups improved over time. Mean (SD) total SPADI score at 15 days was 33.8 (19.6) in the treatment group and 32.8 (17.5) in the control group, p = 0.393. There were no significant differences for any variables in the overall sample. The post hoc analysis found ADM to be associated with a significant decrease in total SPADI score at 15 days compared with ISI (p = 0.049) in individuals with initial passive glenohumeral abduction >45°.
CONCLUSIONS: The effects of ADM on pain and function were not statistically different from those of ISI. However, ADM may be useful in individuals with initial passive glenohumeral abduction >45°.
UNASSIGNED: NCT00724113.
摘要：
背景：肩关节粘连性囊炎（AC）有几种治疗选择。关节扩张优于关节内类固醇注射（ISI）治疗AC的优越性仍存在争议。
目的：评估单关节扩张手术联合早期和强化动员（ADM）和物理治疗的疗效，与ISI和物理治疗相比，持续≥3个月的AC患者。
方法：这是一个前瞻性的，2平行组，2个中心，在三级护理机构中进行的观察者盲法随机对照试验.将患有AC的成人随机分配到治疗组或对照组。使用自我施用的肩痛和残疾指数(SPADI)评估功效。总计,疼痛和残疾SPADI评分15天，6周,以及术后3,6和12个月(15天时的总SPADI:主要结局;其他结局为次要结局)使用协方差分析(ANCOVA)进行组间比较.对被动盂肱外展的初始范围进行了事后分析，没有预先指定，进行了。
结果：每组有33名参与者。两组都随着时间的推移而改善。治疗组15天时SPADI总评分平均值(SD)为33.8(19.6),对照组为32.8(17.5),p=0.393。在整个样本中，任何变量都没有显着差异。事后分析发现，在初始被动盂肱外展>45°的个体中，与ISI（p=0.049）相比，ADM与15天的SPADI总评分显着降低相关。
结论：ADM对疼痛和功能的影响与ISI无统计学差异。然而,ADM可能适用于初始被动肱骨外展>45°的个体。
■NCT00724113。
目的：评估单关节扩张手术联合早期和强化动员（ADM）和物理治疗的疗效，与ISI和物理治疗相比，持续≥3个月的AC患者。
方法：这是一个前瞻性的，2平行组，2个中心，在三级护理机构中进行的观察者盲法随机对照试验.将患有AC的成人随机分配到治疗组或对照组。使用自我施用的肩痛和残疾指数(SPADI)评估功效。总计,疼痛和残疾SPADI评分15天，6周,以及术后3,6和12个月(15天时的总SPADI:主要结局;其他结局为次要结局)使用协方差分析(ANCOVA)进行组间比较.对被动盂肱外展的初始范围进行了事后分析，没有预先指定，进行了。
结果：每组有33名参与者。两组都随着时间的推移而改善。治疗组15天时SPADI总评分平均值(SD)为33.8(19.6),对照组为32.8(17.5),p=0.393。在整个样本中，任何变量都没有显着差异。事后分析发现，在初始被动盂肱外展>45°的个体中，与ISI（p=0.049）相比，ADM与15天的SPADI总评分显着降低相关。
结论：ADM对疼痛和功能的影响与ISI无统计学差异。然而,ADM可能适用于初始被动肱骨外展>45°的个体。
■NCT00724113。
