Peripheral Nerve Stimulation for Subacromial Impingement Syndrome

周围神经刺激治疗肩峰下撞击综合征

• 批准号: 10005047
• 负责人: Richard Dwillis Wilson
• 金额: $ 65.38万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005047
• 关键词: Acromion; Activities of Daily Living; Adrenal Cortex Hormones; Adult; Affect; Aftercare; Anatomy; Articular Range of Motion; Axilla; Biomechanics; Case Series; Characteristics; Chronic; Combined Modality Therapy; Contralateral; Direct Costs; Double-Blind Method; Electrodes; Enrollment; Future; Goals; Impairment; Injections; Intramuscular; Measurement; Measures; Mechanics; Mediating; Medical; Modality; Moods; Motor; Musculoskeletal; Nerve; Neurostimulation procedures of spinal cord tissue; Nociception; Non-Steroidal Anti-Inflammatory Agents; Operative Surgical Procedures; Outcome; Pain; Pain Threshold; Pain interference; Pain management; Participant; Pathology; Patient Selection; Patients; Peripheral Nerve Stimulation; Peripheral Nerves; Phenotype; Physical Examination; Physical therapy; Physicians; Physicians' Offices; Placebos; Population; Practice Guidelines; Primary Hyperalgesias; Quality of life; Randomized Controlled Trials; Refractory; Research; Research Personnel; Rest; Role; Secondary Hyperalgesias; Secondary to; Selection for Treatments; Sensory; Shoulder; Shoulder Impingement Syndrome; Shoulder Pain; Site; Structure; Techniques; Tendon structure; Testing; Therapeutic Intervention; Transcutaneous Electric Nerve Stimulation; Trauma; United States; Visit; central sensitization; chronic pain; chronic shoulder pain; comparative efficacy; cost; deltoid muscle; demographics; design; effective therapy; experience; healthcare community; improved; innovation; insight; multimodality; novel; pain perception; pain reduction; pain relief; pilot trial; psychologic; responders and non-responders; sensory system; socioeconomics; supraspinatus muscle; tibialis anterior muscle; trait

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.

项目摘要 亚急性和慢性肩痛的医学和社会经济影响很高，导致12 在美国，有百万次访问医师，直接费用超过70亿美元。最常见的原因是 肩峰撞击综合征（SIS），占所有肩痛的30％。大约35％ 那些与SI的人是对保守管理的难治性。对于那些失败的人 保守管理，没有既定的治疗方法来减轻痛苦。我们的长期目标是 开发一种治疗性干预措施，以减轻与SI相关的疼痛。我们完成了3周的试点试验 由于SIS引起的慢性肩部疼痛的经皮外周神经刺激（PNS） 对保守治疗的难治，表明60％的受试者成功治疗了持续的疼痛 至少3个月。具有不同动作机制的多模式处理可能比 单峰处理。该2个位点RCT的主要目的是确定多模式的功效 经皮PN与PT结合的处理，减轻了SIS难治性的肩部疼痛 与Shampns + PT的单峰处理相比，保守管理。次要 该多站点RCT的目标是探索PN的机制以治疗SIS，并确定 哪些特征可以预测PNS或PT的成功治疗。为了实现这些目标， 研究人员设计了一个多站点，安慰剂控制的双盲RCT，以比较 pns+pt至shampns+pt。疼痛，疼痛干扰ADL，ADL，QOL，肩膀的能力 生物力学（肩部外展强度，肩部运动范围）和中央敏化度量 （疼痛阈值，继发性痛觉过敏和时间求和）将被测量。参与者会 接下来是在治疗结束后总共24周。