Shi's Center of Orthopedics and Traumatology (Institute of Traumatology, Shuguang Hospital), Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Trials. 2023 Nov 27;24(1):765. doi: 10.1186/s13063-023-07810-2.
Frozen shoulder (FS) is a common condition that can cause severe pain and limited range of motion in the shoulder joint. While intra-articular steroid injection has been shown to be an effective treatment for FS, manipulation under anesthesia (MUA) is an alternative treatment that has gained popularity in recent years. However, there is a lack of evidence regarding the effectiveness of MUA on FS patients with concomitant rotator cuff injury or tear. Though a few studies have shown that MUA is not associated with rotator cuff tears, and will not exacerbate the injury, more high-quality studies with bigger sample sizes are needed. Therefore, the aim of this multi-center, single-blinded, randomized, parallel-group, superiority study is to compare the efficacy of MUA versus intra-articular steroid injection in the treatment of FS patients with a diagnosis of rotator cuff injury or tear by MRI.
A parallel, single-blinded, multi-center randomized controlled trial of 320 patients will be conducted at three hospitals of China. Eligible patients with frozen shoulder and rotator cuff injury or tear diagnosed by MRI will be randomly assigned to, in equal proportions, the manipulation under anesthesia group and the intra-articular steroid injection group via a central randomization system, undergoing a corresponding operation on day one and a sequent physical exercise for 14 days. The primary outcome is the comprehensive efficacy evaluation (total effective rate) and the change of Constant-Murley Score. Outcome assessors and data analysts will be blinded, and participants will be asked not to reveal their allocation to assessors.
This study aims to explore the superiority of manipulation under anesthesia in reducing pain and improving shoulder function in frozen shoulder patients accompanied with rotator cuff injury. To provide a scientific basis for the dissemination and application of manipulation under anesthesia, and a better knowledge for the role of MUA in the treatment of frozen shoulder accompanied with rotator cuff injury.
Chictr.org.cn ChiCTR2200067122 . Registered on 27 December 2022. ChiCTR is a primary registry of the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) network and includes all items from the WHO Trial Registration data set in Trial registration.
冻结肩（FS）是一种常见的疾病，可导致肩关节严重疼痛和活动范围受限。虽然关节内类固醇注射已被证明是治疗 FS 的有效方法，但麻醉下手法松解（MUA）是近年来流行的替代治疗方法。然而，关于 MUA 治疗伴有肩袖损伤或撕裂的 FS 患者的有效性，证据不足。尽管有几项研究表明 MUA 与肩袖撕裂无关，并且不会加重损伤，但需要更多高质量、大样本量的研究。因此，本多中心、单盲、随机、平行组、优效性研究旨在比较 MUA 与关节内类固醇注射治疗 MRI 诊断为肩袖损伤或撕裂的 FS 患者的疗效。
在中国的三家医院进行了一项 320 例患者的平行、单盲、多中心随机对照试验。通过中央随机系统，将符合 MRI 诊断的冻结肩和肩袖损伤或撕裂的合格患者等比例随机分为麻醉下手法松解组和关节内类固醇注射组，在第 1 天进行相应的手术，然后进行为期 14 天的连续物理治疗。主要结局是综合疗效评价（总有效率）和 Constant-Murley 评分的变化。结局评估者和数据分析者将被设盲，参与者将被要求不向评估者透露其分组情况。
本研究旨在探讨麻醉下手法松解在减轻疼痛和改善伴有肩袖损伤的冻结肩患者肩部功能方面的优势。为麻醉下手法松解的推广应用提供科学依据，为 MUA 在治疗冻结肩伴肩袖损伤中的作用提供更好的认识。
Chictr.org.cn ChiCTR2200067122。于 2022 年 12 月 27 日注册。Chictr 是世界卫生组织国际临床试验注册平台（WHO ICTRP）网络的主要注册机构，包含 WHO 临床试验注册数据集中的所有项目。
