 英语晨读 · 山东省立医院疼痛科英语晨读已经坚持10余年的时间了，每天交班前15分钟都会精选一篇英文文献进行阅读和翻译。一是可以保持工作后的英语阅读习惯，二是可以学习前沿的疼痛相关知识。我们会将晨读内容与大家分享，助力疼痛学习。 本次文献选自Rangan A, Brealey SD , Keding A, et al. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial[J]. The Lancet, 2020, 396(10256):977-989.本次学习由魏广福主治医师主讲。 Summary 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. 摘要 背景 麻醉下手法松解和关节镜下关节囊松解是昂贵且有创的治疗方法，但其有效性仍不确定。我们比较了这两种外科治疗与早期结构性物理治疗加类固醇注射。 Methods In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary carefor 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. 方法 在这个多中心、实用、三臂、优势随机试验中，从英国35个医院招募了接受次级治疗的原发性冷冻肩关节患者。参与者为成年(≥18岁)单侧冻结肩，其特征是受限于被动外旋(≥50%)受累肩关节。参与者被随机分配(2:2:1)接受麻醉下手法松解、关节镜下关节囊松解或早期结构物理治疗。在麻醉下手法松解中，外科医生在参与者全身麻醉的情况下拉伸并撕裂紧绷的肩关节囊，辅以类固醇注射。关节镜下的关节囊松解，也是在全身麻醉下进行的，包括在旋转肌间隙切开收缩的前囊，然后手法松解，可选择注射类固醇。两种形式的手术都配合术后物理治疗。早期的结构物理治疗包括松动技术和家庭锻炼计划辅以类固醇注射。早期结构物理治疗和术后物理治疗包括12个疗程，长达12周。主要结果用牛津肩伤评分(OSS;0-48)根据初始随机组进行分析。我们寻求物理治疗和任何形式的手术之间的5个OSS点的目标差异，或手法松解和关节囊松解之间的4个OSS点的目标差异。试验注册号为ISRCTN48804508。 Findings Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomlyassigned. 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 £20 000 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). 在2015年4月1日至2017年12月31日期间，我们筛查了914例患者，其中503例(55%)随机分配。在12个月内,OSS的数据来自189名(94%)的201名参与者分配给手法松解(平均评分38.3点,95% CI 36.9到39.7),191(94%)的203名参与者分配给关节囊松解(40.3点38.9到41.7),和93(94%)的99名参与者分配给物理治疗(37.2分,35.3 - 39.2)。松解组与手法松解组比较，平均差异为2.01分(0.10 ~ 3.91)，松解组与理疗组比较，平均差异为3·06分(0.71 ~ 5.41)，手法松解组与理疗组比较，平均差异为1.05分(1.28 ~ 3.39)。8个严重的不良事件报道见于关节囊手术松解和2个手法松解。在每个质量调整生命年愿意支付£20000的阈值下，麻醉手法松解具有最高的成本效益的可能性(0.8632，相比之下物理治疗为0.1366，关节囊手术松解为0.0002)。 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. 解释 在12个月的主要终点，所有评估肩部疼痛和功能(OSS)的平均差异都小于目标差异。因此，三种干预方法在临床上均无优势.关节镜下关节囊松解风险较高，麻醉下手法松解成本效益最高。 |
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