英国牛津大学Sally Hopewell团队比较了渐进式运动与最佳实践建议（有或没有皮质类固醇注射）治疗肩袖疾病的效果。相关论文发表在2021年7月12日出版的《柳叶刀》杂志上。
皮质类固醇注射和理疗运动项目是治疗肩袖疾病的常用方法，但其疗效尚不确定。该研究宗旨是比较一种渐进运动方案与单次最佳实践理疗建议（有或没有皮质类固醇注射）对成人肩袖疾病的临床效果和成本效益。
在这项务实、多中心、非劣效、随机对照试验中（2 × 2因子），研究组从20个英国国家卫生服务信托基金招募18岁及以上肩袖功能障碍（过去6个月内新发）的患者。排除有严重肩部创伤（如脱位、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（如炎性关节炎、肩周炎或盂肱关节不稳）病史的患者，纳入在过去6个月接受皮质类固醇注射或物理疗法治疗肩部疼痛，或正在考虑手术治疗的患者。
将患者按1：1：1：1随机分配，分别接受渐进运动（≤6个疗程）、最佳实践建议（一个疗程）、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进行最佳实践建议。主要结局是12个月内的肩痛和残疾指数（SPADI）评分，以意向治疗为基础进行分析（统计显著性为1%）。
2017年3月10日至2019年5月2日，研究组共筛查了2287名患者。708名患者被随机分配，其中渐进运动组174名、最佳实践建议组174名、皮质类固醇注射然后渐进运动组182名、皮质类固醇注射然后最佳实践建议组178名。在12个月内，渐进运动组166例（95%）患者、最佳实践建议组164例（94%）患者、皮质类固醇注射后渐进运动组177例（97%）患者和皮质类固醇注射后最佳实践建议组175例（98%）患者的SPADI数据可用。经过12个月的分析，研究组未发现渐进运动和最佳实践建议之间SPADI评分存在差异的证据。在12个月的分析中，研究组也没有发现注射与不注射皮质类固醇之间存在差异的证据。所有组均未报告严重不良事件。
研究结果表明，渐进式运动在改善肩痛和功能方面并不优于理疗师指导的最佳实践建议课程。肩峰下皮质类固醇注射对肩袖疾患患者无长期疗效。
附：英文原文
Title: Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2×2 factorial, randomised controlled trial
Author: Sally Hopewell, David J Keene, Ioana R Marian, Melina Dritsaki, Peter Heine, Lucy Cureton, Susan J Dutton, Helen Dakin, Andrew Carr, Willie Hamilton, Zara Hansen, Anju Jaggi, Chris Littlewood, Karen L Barker, Alastair Gray, Sarah E Lamb, Marcus Bateman, Alison Hallett, Helen Thompson, Elaine Willmore, Lucy McCann, Jonathan Price, Neil Smith, Harry Kardamilas, Matt Hurst, Tim Andrews, Lori Wells, Chloe De Matas, Arun Jaykumar, Sean Grove, Corinne Birch, Julie Bury, James Blacknall, Sally Jessop, Llewelyn Boucher, Robert Sandbach, Stacey Lalande, Gill Dickson, Treena Larkin, Carole Cummings
Issue&Volume: 2021-07-12
Abstract:
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.
DOI: 10.1016/S0140-6736(21)00846-1
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00846-1/fulltext
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
官方网址：http://www.thelancet.com/
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本期文章：《柳叶刀》：Online/在线发表
