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A novel taping therapy for pain after arthroscopic shoulder surgery: study protocol for a randomised controlled pilot trial

机译:关节镜肩外科疼痛的一种新型胶带治疗:随机控制试验试验试验的研究方案

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In recent years, the number of arthroscopic shoulder surgeries has increased given that the intervention is minimally invasive. However, postoperative pain is one of the most common symptoms of patients who undergo arthroscopic surgery. Although pharmacological treatments and brachial plexus blocks for reducing pain are currently used, the adherence rate of interventions is low, and adverse effects often occur. Chimsband, made up of silver and optic fibres, is a novel taping therapy that stimulates patients' acupoints and is expected to relieve pain with few adverse effects. The aim of this study is to explore the effectiveness of Chimsband to relieve pain following arthroscopic shoulder surgery. This is a randomised, parallel, controlled, exploratory clinical trial. Thirty participants who undergo arthroscopic shoulder surgery will be randomly allocated to an intervention or a control group. Both groups will receive 10 sessions of interferential current therapy within a period of 2 weeks, while the intervention group will additionally receive taping therapy after undergoing physical therapy. Two follow-up visits will be scheduled after the last treatment session. The primary outcome variable will be the difference in the visual analogue scale (VAS) scores between baseline and first follow-up evaluation after the end of 10 treatment sessions. The secondary outcomes will be VAS at the end of the second week, shoulder pain and disability index, range of motion, VAS while sleeping, questionnaire of blood stasis pattern identification at two follow-up visits, and number of bands used per visit. Outcomes will be evaluated at baseline, 2 weeks from visit 1 (+ within 6?days) after commencement, and at 4 weeks from visit 1 (+ within 6?days) follow-up. This study will be the first clinical trial to explore the effect and safety of Chimsband on postoperative shoulder pain. It would provide clinical evidence to conduct further taping therapy studies for relieving musculoskeletal pain. Korean Clinical Trial Registry, KCT0002355 . Registered on 13 June 2017.
机译:近年来,鉴于干预是微创的侵入性,关节镜肩部手术的数量增加。然而,术后疼痛是接受关节镜手术的患者中最常见的症状之一。虽然目前使用药理学治疗和用于减少疼痛的臂丛丛块,但干预的粘附率低,并且经常发生不利影响。由银和光纤组成的ChimsBand是一种新型胶带治疗,刺激患者的穴位,预计会缓解疼痛很少的不良反应。本研究的目的是探讨ChimsBand在关节镜肩部手术后缓解疼痛的有效性。这是随机,平行,受控,探索性的临床试验。接受关节镜肩部手术的30名参与者将随机分配给干预或对照组。两组将在2周内获得10次干扰电流疗法,而干预组将在接受物理治疗后另外接受胶带治疗。在最后一次治疗会议后,将安排两个后续访问。主要结果变量将是基线之间的视觉模拟量表(VAS)分数的差异,并在10个处理会话结束后的第一次随访评估。二次结果将在第二周结束时,肩痛和残疾指数,运动范围,睡觉时,血液屏幕调查结果的两次后续访问,以及每次访问使用的频段数量。结果将在基线评估,从访问后的1(+在6.?天内)2周,从访问后4周(+在6?天内)后续行动。本研究将是第一项探讨ChimsBand术后肩痛效果和安全性的临床试验。它将提供临床证据,以进行缓解肌肉骨骼疼痛的进一步录取治疗研究。韩国临床试验登记处,KCT0002355。注册于2017年6月13日。

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