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.