英国约克大学Amar Rangan团队比较了二级护理中三种成人原发性肩周炎治疗方法的疗效差异。2020年10月3日，该研究发表在《柳叶刀》杂志上。

麻醉下手术和关节镜下囊松解术治疗肩周炎昂贵且有侵入性，但其疗效仍不明确。研究组将这两种手术干预与早期结构化理疗加类固醇注射进行了比较。

在这项多中心、实用、三臂优势随机试验中，2015年4月1日至2017年12月31日，研究组从英国35家医院招募了914例接受二级护理以治疗原发性肩周炎的患者，均为单侧肩周炎的成人（≥18岁），其特征是受累肩膀的被动外旋受限制（≥50％）。

其中503例接受随机分组，将其按2：2：1分配，其中201名接受麻醉下手术，203名接受关节镜下囊松解术，99名接受物理治疗。主要结局为随机分组后12个月的牛津肩膀评分（OSS； 0-48分）。

在12个月时，手术组中189名患者的OSS平均评分为38.3分，关节囊松解术组中191名患者为40.3分，物理治疗组中93名患者为37.2分。关节囊松解术组与手术组之间的平均差异为2.01分，与物理治疗组之间的差异为3.06分，手术组与物理治疗组之间的差异为1.05分。

关节囊松解术组中发生8例严重不良事件，手术组中有2例。在每个质量调整生命年意愿支付的20000英镑阈值下，麻醉下手术具有最高的成本效益，为0.8632，物理治疗为0.1366，关节囊松解术为0.0002。

总之，麻醉下手术、关节镜下囊松解术、物理治疗在12个月时的肩功能均无临床差异。关节镜下囊松解术的风险更高，麻醉下手术的成本效益最高。

附：英文原文

Title: Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial

Author: Amar Rangan, Stephen D Brealey, Ada Keding, Belen Corbacho, Matthew Northgraves, Lucksy Kottam, Lorna Goodchild, Cynthia Srikesavan, Saleema Rex, Charalambos P Charalambous, Nigel Hanchard, Alison Armstrong, Andrew Brooksbank, Andrew Carr, Cushla Cooper, Joseph J Dias, Iona Donnelly, Catherine Hewitt, Sarah E Lamb, Catriona McDaid, Gerry Richardson, Sara Rodgers, Emma Sharp, Sally Spencer, David Torgerson, Francine Toye, Philip Ahrens, Cheryl Baldwick, Amit Bidwai, Asim Butt, Jamie Candal-Couto, Charalambos Charalambous, Mark Crowther, Steve Drew, Sunil Garg, Richard Hawken, Cormac Kelly, Matthew Kent, Kapil Kumar, Tom Lawrence, Christopher Little, Iain Macleod, Jodi George Malal, Tim Matthews, Damian McClelland, Neal Millar, Prabhakar Motkur, Rajesh Nanda, Chris Peach Peach, Tim Peckham, Jayanti Rai, Ravi Ray, Douglas Robinson, Philip Rosell, Adam Ruman, Adnan Saithna, Colin Senior, Harish Shanker, Barnaby Sheridan, Kanthan Theivendran, Simon Thomas, Balachandran Venateswaran

Issue&Volume: 2020/10/03

Abstract:

Background

Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection.

Methods

In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0–48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.

Findings

Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (–1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of ￡20000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release).

Interpretation

All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective.

DOI: 10.1016/S0140-6736(20)31965-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31965-6/fulltext