Implanted PNS for Shoulder Pain in Stroke

描述(由申请人提供)：中风后的肩痛是一个主要的康复问题，影响到大约60%的中到重度受损的中风幸存者。研究小组证明了短期、经皮肌肉内(IM)周围神经刺激(PNS)在治疗中风后肩痛方面的有效性。然而，只有那些在中风后18个月内接受治疗的人才能获得持久的治疗效果。18个月后接受治疗的患者在治疗结束时疼痛显著减轻，但在3个月内疼痛又回来了。为了治疗这一更具挑战性的人群，提出了一项探索性的安慰剂对照、随机对照试验，以证明完全可植入的PNS系统的安全性和有效性。试验分两个阶段进行。在试验阶段，那些从短期经皮IM PNS中受益，但疼痛复发的参与者。在植入阶段，这些参与者接受完全植入的IM PNS系统，并被随机接受IM PNS或第二疗程的短期经皮IM PNS治疗。结果包括疼痛、运动障碍、ADLS和生活质量。为了探索机制，在两个阶段的参与者都要接受定量的感觉和运动测试。

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 demonstrated the efficacy of short-term, percutaneous intramuscular (IM) peripheral nerve stimulation (PNS) in treating shoulder pain following stroke. However, only those individuals who received treatment within 18 months of their stroke experienced enduring treatment effect. Those treated after 18 months experienced significant pain reduction at the end of treatment, but pain returned within 3 months. To treat this more challenging population, an exploratory placebo controlled, randomized controlled trial is proposed to demonstrate the safety and efficacy of a fully implantable PNS System. The trial has 2 stages. During the Trial Stage, participants who experience benefit from short-term percutaneous IM PNS, but in whom pain returns are identified. During the Implant Stage, these participants receive the fully implanted IM PNS system and are randomized to receive IM PNS or a second course of short-term percutaneous IM PNS treatment. Outcomes include pain, motor impairment, ADLs and quality of life. In order to explore mechanisms, participants in both Stages undergo quantitative sensory and motor testing.