Two Stage ES for Hemiplegic Shoulder Pain

描述（由申请人提供）：卒中后肩痛是一个主要的康复问题，影响约60%的中度至重度受损卒中幸存者。研究小组最近证明了经皮肌内（IM）电刺激（ES）治疗中风后肩痛的疗效。然而，只有那些在中风后18个月内入组的个体经历了持久的治疗效果。在这18个月期间之后登记的参与者在治疗结束时经历了显着的疼痛减轻，但治疗益处并没有长期持续。该人群可能受益于完全植入的ES系统。拟进行一项I期可行性试验，以证明两阶段植入式ES系统治疗卒中后18个月以上患者肩痛的安全性和初步疗效。在试验阶段，将确定从经皮IM ES中短期获益的卒中幸存者。在植入阶段，这些受试者将接受完全植入的ES系统，并接受6个月的随访。结局指标将包括简明疼痛量表问题12、影像学盂肱半脱位、Fugl-Meyer运动评估和手臂运动能力测试。 公共卫生相关性：卒中后肩痛是一个主要的康复问题，影响约60%的中度至重度受损卒中幸存者，并与恢复不良、日常生活活动受损和生活质量下降有关。慢性中风幸存者的肩痛尤其难以治疗。本项目将评估一种新型的两阶段植入式电刺激系统治疗慢性中风幸存者肩痛的有效性。

DESCRIPTION (provided by applicant): Shoulder pain following stroke is a major rehabilitation problem affecting approximately 60% of moderate to severely impaired stroke survivors. The investigative team recently demonstrated the efficacy of percutaneous intramuscular (IM) electrical stimulation (ES) in treating post-stroke shoulder pain. However, only those individuals enrolled within 18-mo of their stroke experienced enduring treatment effect. Participants enrolled after this 18-mo period experienced significant pain reduction at the end of treatment, but the therapeutic benefit did not persist in the long-term. This population may benefit from a fully implanted ES system. A phase I feasibility trial is proposed to demonstrate the safety and initial efficacy of a Two-stage Implanted ES system for the treatment of shoulder pain for those who are greater than 18-mo from stroke. During the Trial Stage, stroke survivors who experience short-term benefit from percutaneous IM ES will be identified. During the Implant Stage, these participants will receive the fully implanted ES system and be followed for 6-mo. Outcomes measures will include the Brief Pain Inventory question 12, radiographic glenohumeral subluxation, Fugl-Meyer Motor Assessment and the Arm Motor Ability Test. PUBLIC HEALTH RELEVANCE: Shoulder pain following stroke is a major rehabilitation problem affecting approximately 60% of all moderate to severely impaired stroke survivors, and is associated with poor recovery, impaired activities of daily living and reduced quality of life. Shoulder pain among chronic stroke survivors is especially difficult to treat. This project will evaluate the effectiveness of a novel two-stage implanted electrical stimulation system for treating shoulder pain among chronic stroke survivors.