Peripheral Nerve Stimulation for Subacromial Impingement Syndrome

项目摘要 亚急性和慢性肩痛的医疗和社会经济影响很高，导致12 在美国，医生的就诊次数超过100万次，直接成本超过70亿美元。最常见的原因是 肩峰下撞击综合征（SIS），占所有肩部疼痛的30%。约35%的 SIS患者保守治疗无效。对于那些失败的人来说 保守治疗，没有既定的治疗方法来减少他们的痛苦。我们的长期目标是 开发治疗干预措施，以减少与SIS相关的疼痛。我们完成了为期3周的试点试验 经皮周围神经刺激（PNS）治疗SIS引起的慢性肩痛， 保守治疗难治性，显示60%的受试者成功治疗了持续 至少3个月。具有不同作用机制的多模式治疗可能比单一治疗更有效。 单一模式治疗。这项2中心RCT的主要目的是确定多模式治疗的疗效。 经皮PNS联合PT治疗减轻难治性SIS继发肩痛 保守治疗与shamPNS + PT的单一模式治疗相比。次级 这项多中心随机对照试验的目的是探讨PNS治疗SIS的机制，并确定 这些特征可以预测PNS或PT的成功治疗。为了实现这些目标， 研究人员设计了一项多中心、安慰剂对照、双盲随机对照试验， PNS+PT至假PNS +PT。疼痛指标、疼痛对ADL的干扰、ADL能力、QoL、肩部 生物力学（肩关节外展力量、肩关节活动范围）和中枢致敏措施 (pain阈值、继发性痛觉过敏和时间总和）。参与者将被 在治疗结束后随访总共24周。

PROJECT SUMMARY The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of all shoulder pain. Approximately 35% of those who present with SIS are refractory to conservative management. For those who have failed conservative management, there are no established treatments to reduce their pain. Our long-term goal is to develop a therapeutic intervention to reduce pain related to SIS. We completed a pilot trial of 3-week percutaneous peripheral nerve stimulation (PNS) for those with chronic shoulder pain due to SIS that was refractory to conservative treatment that showed 60% of subjects had successful treatment of pain that lasted at least 3 months. A multimodal treatment with different mechanisms of action may be more efficacious than a unimodal treatment. The primary objective of this 2 site RCT is to determine the efficacy of multimodal treatment of percutaneous PNS combined with PT in reducing shoulder pain secondary to SIS refractory to conservative management compared with the unimodal treatment of shamPNS + PT. The secondary objectives of this multisite RCT is to explore mechanisms of PNS for the treatment of SIS, and to determine which characteristics can predict successful treatment with PNS or PT. In order to accomplish these objectives, the investigators designed a multi-site, placebo controlled, double-blinded RCT to compare the efficacy of PNS+PT to shamPNS+PT. Measures of pain, pain interference with ADLs, capacity for ADLs, QoL, shoulder biomechanics (shoulder abduction strength, shoulder range of motion), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.