Two Stage ES for Hemiplegic Shoulder Pain

描述（由申请人提供）：中风后肩痛是影响约60%中度至重度中风幸存者的主要康复问题。研究小组最近证明了经皮肌内电刺激（IM）治疗中风后肩痛的疗效。然而，只有那些在中风后18个月内接受治疗的人才有持久的治疗效果。18个月后，参与者在治疗结束时经历了明显的疼痛减轻，但治疗效果并没有长期持续。这类人群可能受益于完全植入的ES系统。一项I期可行性试验提出，以证明两阶段植入ES系统治疗18个月以上中风患者肩痛的安全性和初步有效性。在试验阶段，将确定从经皮内腔注射中获得短期受益的中风幸存者。在植入阶段，这些参与者将接受完全植入的ES系统并随访6个月。结果测量将包括简短疼痛量表问题12，x线摄影肩关节半脱位，Fugl-Meyer运动评估和手臂运动能力测试。

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.