Two Stage ES for Hemiplegic Shoulder Pain

两阶段 ES 治疗偏瘫肩痛

• 批准号: 8265549
• 负责人: John Chae
• 金额: $ 15.04万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8265549
• 关键词: Activities of Daily Living; Affect; Brief Pain Inventory; Clinical Research; Development; Devices; Dose; Effectiveness; Electric Stimulation; Enrollment; Equipment Malfunction; Exhibits; Functional disorder; Implant; Implanted Electrodes; Individual; Infection; Intervention; Intramuscular; Mediating; Motor; Muscle; Nerve; Outcome; Outcome Measure; Pain; Participant; Patients; Phase; Population; Quality of life; Randomized Clinical Trials; Recovery; Rehabilitation Outcome; Rehabilitation therapy; Relative (related person); Reporting; Safety; Shoulder; Shoulder Pain; Staging; Stroke; Surface; Survivors; System; Testing; Therapeutic; Therapeutic Effect; Time; Upper Extremity; arm; base; chronic stroke; experience; hemiparesis; implantation; improved; novel; post stroke; standard of care; success; treatment effect

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.

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，这些参与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。