Background

Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Methods

In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28.

Findings

Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference −0·66 [99% CI −4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (−1·11 [–4·47 to 2·26]). No serious adverse events were reported.

Interpretation

Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders.

Funding

UK National Institute for Health Research Technology Assessment Programme.

中文翻译：

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渐进式运动与最佳实践建议相比，注射或不注射皮质类固醇，治疗肩袖疾病 (GRASP)：一项多中心、实用、2×2 因子随机对照试验

背景

皮质类固醇注射和物理治疗锻炼计划通常用于治疗肩袖疾病，但治疗效果尚不确定。我们旨在比较渐进式锻炼计划与单次最佳实践物理治疗建议（加或不加皮质类固醇注射）在成人肩袖疾病中的临床有效性和成本效益。

方法

在这项务实的、多中心的、优越的、随机对照试验（2 × 2 因子）中，我们从 20 个英国国家卫生服务信托基金中招募了患者。我们纳入了 18 岁或以上患有肩袖疾病（过去 6 个月内新发作）的患者。如果患者有严重肩部创伤病史（例如，脱臼、骨折或需要手术的全层撕裂）、影响肩部的神经系统疾病、其他肩部疾病（例如，炎症性关节炎、肩周炎或盂肱关节不稳），则被排除在外)，在过去 6 个月内因肩痛接受过皮质类固醇注射或物理治疗，或正在考虑进行手术。患者被随机分配（中央计算机生成系统，1:1:1:1）进行渐进式锻炼（≤6 次）、最佳实践建议（1 次）、皮质类固醇注射然后进行渐进运动，或皮质类固醇注射然后最佳实践建议。主要结果是超过 12 个月的肩痛和残疾指数 (SPADI) 评分，在意向治疗的基础上进行分析（统计学意义设定为 1%）。该试验已在国际标准随机对照试验注册库 ISRCTN16539266 和 EuDRACT 注册，注册号为 2016-002991-28。

发现

在 2017 年 3 月 10 日至 2019 年 5 月 2 日期间，我们筛查了 2287 名患者。708 名患者被随机分配到渐进运动 (n=174)、最佳实践建议 (n=174)、皮质类固醇注射后渐进运动 (n=182) 或皮质类固醇注射后最佳实践建议 (n=178)。在 12 个月内，渐进运动组的 166 名（95%）患者、最佳实践建议组的 164 名（94%）患者、皮质类固醇注射后渐进运动组的 177 名（97%）患者和 175（ 98%）在皮质类固醇注射然后是最佳实践建议组。在超过 12 个月的分析中，我们发现没有证据表明渐进式锻炼和最佳实践建议之间的 SPADI 评分存在差异（调整后的平均差 -0·66 [99% CI -4·52 至 3·20]）。在超过 12 个月的分析中，我们还没有发现皮质类固醇注射与不注射之间存在差异的证据（-1·11 [–4·47 到 2·26]）。没有报告严重的不良事件。

解释

在改善肩部疼痛和功能方面，渐进式锻炼并不优于物理治疗师的最佳实践建议会议。肩峰下皮质类固醇注射对肩袖疾病患者没有长期益处。

资金

英国国家卫生研究院技术评估计划。