Electrical muscle stimulation for the treatment of functional posterior shoulder instability

肌肉电刺激治疗功能性后肩不稳定

• 批准号: 417627116
• 负责人: Privatdozent Dr. Doruk Akgün, since 2/2022
• 金额: --
• 依托单位: Schulthess Klinik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/417627116?language=en
• 关键词: Electrical; muscle; stimulation; treatment; functional

Pathological muscle activation patterns can generate a force imbalance of stabilizing shoulder muscles and result in non-controllable, arm-position dependent functional posterior shoulder instability (FPSI). Affected patients are typically adolescents who suffer from severe repetitive shoulder dislocations leading to functional impairment, constant feeling of instability, and pain. Conventional treatment options including conservative as well as surgical interventions are often ineffective, creating a need for treatment alternatives. An experimental conservative treatment protocol based on electrical muscle stimulation showed promising results in a pilot trial involving patients suffering from FPSI after previously failed conventional treatment. The goal of the proposed project is to evaluate the general applicability and effectiveness of this experimental treatment alternative in a multi-centric, randomized controlled trial. Study participants will be allocated randomly to the experimental or control intervention, each consisting of 18 standardized one-hour training sessions evenly distributed over the course of 6 weeks. A longitudinal comparison of the pre-defined subjective and objective outcome parameters will be performed. After reaching the primary endpoint (Western Ontario Shoulder Instability Index at 3 months), optional bi-directional cross-over is permitted. The proposed project challenges the current treatment paradigms for FPSI and will help to evaluate and potentially establish a much-needed new treatment option for patients suffering from this debilitating pathology.

病理性肌肉激活模式可产生稳定肩部肌肉的力不平衡，并导致不可控的、臂位依赖性功能性肩关节后不稳定（FPSI）。受影响的患者通常是青少年，他们患有严重的重复性肩关节脱位，导致功能障碍，持续的不稳定感和疼痛。传统的治疗选择，包括保守以及手术干预往往是无效的，创造了治疗替代品的需要。一项基于肌肉电刺激的实验性保守治疗方案在一项涉及FPSI患者的试点试验中显示出有希望的结果，这些患者在先前的常规治疗失败后患有FPSI。该项目的目的是在一项多中心、随机对照试验中评估这种实验性治疗方案的普遍适用性和有效性。研究参与者将被随机分配到实验或对照干预组，每组包括18个标准化的一小时培训课程，平均分布在6周的课程中。将对预定义的主观和客观结局参数进行纵向比较。在达到主要终点（3个月时的西安大略肩关节不稳定指数）后，允许可选的双向交叉。拟议的项目挑战了FPSI目前的治疗模式，并将有助于评估和潜在地为患有这种衰弱性病理的患者建立急需的新治疗选择。