The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial.
The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial.
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DOI：
10.1016/s0140-6736(18)31572-1
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发表时间：
2018-10-20
期刊：
影响因子：
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通讯作者：
Roddy E
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作者：
Chesterton LS;Blagojevic-Bucknall M;Burton C;Dziedzic KS;Davenport G;Jowett SM;Myers HL;Oppong R;Rathod-Mistry T;van der Windt DA;Hay EM;Roddy E
据我们所知，腕管综合征常用的保守治疗的比较有效性尚未在初级保健以前进行评估。我们的目的是比较夜间夹板与皮质类固醇注射在减轻轻度或中度腕管综合征患者症状和改善手功能方面的临床和成本效益。我们在从25家初级和社区肌肉骨骼诊所和服务机构招募的轻度或中度腕管综合征成人（≥18岁）中进行了这项随机、开放标签、务实的试验。新发特发性轻度或中度腕管综合征至少持续6周的患者符合条件。我们随机分配（1：1）患者（按研究中心排列为2和4个区组），通过在线网络或第三方电话服务接受单次注射20 mg醋酸甲泼尼龙（40 mg/mL）或夜间休息夹板，持续6周。患者和临床医生无法对干预措施视而不见。主要结局是6周时波士顿腕管问卷（BCTQ）的总体评分。我们使用意向治疗分析，对缺失数据进行多重插补，这对治疗组分配是隐藏的。该试验已在欧洲临床试验数据库（编号2013-001435-48）和ClinicalTrial.gov（编号NCT 02038452）中注册。在2014年4月17日至2016年12月31日期间，234名参与者被随机分配（118名为夜间夹板组，116名为皮质类固醇注射组），其中212名（91%）在6周时完成了BCTQ。皮质类固醇注射组6周时的BCTQ评分（平均值2.02 [SD 0.81]）显著优于夜间夹板组（2.29 [0.75];校正平均差异-0.32; 95%CI-0.48至-0.16; p= 0.0001）。未报告不良事件。与夜间休息夹板相比，单次皮质类固醇注射在6周时显示出上级临床有效性，使其成为初级保健中出现的轻度或中度腕管综合征快速症状反应的治疗选择。英国关节炎研究所。
To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference −0·32; 95% CI −0·48 to −0·16; p=0·0001). No adverse events were reported. A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. Arthritis Research UK.