Electrical stimulation to reduce pain and improve function after knee replacement

电刺激可减轻膝关节置换术后的疼痛并改善功能

• 批准号: 10324450
• 负责人: Joseph Wilder Boggs
• 金额: $ 95.44万
• 依托单位: SPR THERAPEUTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324450
• 关键词: Address; Adopted; Adoption; American; Anatomy; Area; Case Series; Catheters; Chronic; Clinical Research; Devices; Double-Blind Method; Effectiveness; Electric Stimulation; Feedback; Goals; Growth; Home; Human Resources; Incidence; Innovative Therapy; Knee; Lead; Movement; Needles; Nerve; Operative Surgical Procedures; Opioid; Pain; Pain management; Patients; Peripheral Nerve Stimulation; Phase; Physical Function; Physical Rehabilitation; Physicians; Physiologic pulse; Postoperative Pain; Postoperative Period; Procedures; Quality of life; Randomized Controlled Trials; Recovery; Rehabilitation therapy; Research; Risk; Safety; Secure; Stretching; System; Systems Development; Testing; Time; Translating; Ultrasonography; Unmarried person; Variant; advanced system; chronic pain; clinical practice; commercialization; design; disability; effective therapy; experience; functional improvement; health care settings; improved; improved functioning; infection risk; innovation; knee replacement arthroplasty; minimally invasive; multimodality; non-opioid analgesic; novel; opioid use; pain reduction; pain relief; pathogen; side effect; skills; standard care; standard of care

PROJECT SUMMARY Total knee arthroplasty (TKA) is a widely-performed surgical procedure to treat disabling knee conditions, but approximately half of all TKA patients experience moderate to severe pain during the critical first 4 weeks after TKA that can interfere with rehabilitation. Patients who are unable to engage fully in rehabilitation during this period risk substantial delays in return to normal function, reduced independence and quality of life, and have increased risk of developing chronic pain. Despite use of multimodal pain management, many patients still experience significant pain and require opioids that are associated with debilitating side effects, interfering with rehabilitation and delaying recovery during the critical first 4 weeks after TKA. The previous Phase I and II studies were successfully completed, demonstrating that percutaneous peripheral nerve stimulation (PNS) can provide immediate improvements in postoperative pain and knee mobility and produces greater relief of postoperative pain and improved function compared to standard of care alone during the first 4 weeks following TKA, resulting in lower incidence of chronic postoperative pain and opioid use at 3 months following TKA. The goal of the present Phase IIB project is to develop and test an advanced percutaneous PNS system that can: translate into routine clinical practice the benefits demonstrated in the previous Phase I and II clinical studies, overcome the challenges documented in these studies, and meet the design requirements to be deployed consistently and successfully by physicians with a wide range of skill sets in anesthetized patients before surgery to treat postoperative pain consistently throughout the critical postoperative 4-week rehabilitation window without the limitations of the existing standard of care. The project aims are to develop and test a multi- contact open-coil lead designed to widen the target area in which the lead can be placed using only anatomical landmarks and ultrasound guidance, avoiding the need to test stimulation and assess patient feedback (Aim 1); develop and test a unified introducer and connector system to enable a single physician to quickly and accurately deploy the lead followed by the lead connector without assistance (Aim 2); develop and test the external pulse generator, cabling, and user interfaces to complete development of the system (Aim 3); and determine if the proposed system enables quick and accurate lead placement in a clinical study (Aim 4). Successful completion of the aims will result in a novel percutaneous PNS system that is ready for submission for FDA 510(k) clearance, with a goal of providing in diverse healthcare settings the same pain relief, opioid reduction, and functional improvements demonstrated in previous studies in expert research settings. Commercialization of this innovative PNS system will substantially impact clinical practice by providing physicians and their patients with a non-opioid, minimally-invasive, simple, safe, and effective treatment option, and facilitating adoption on a wide scale as the new standard of care after TKA for pain relief and improved physical function that can extend into the home rehabilitation period after discharge to enable improved function, independence, and quality of life.

项目摘要 全膝关节置换术（TKA）是一种广泛实施的外科手术，用于治疗膝关节残疾， 但大约一半的TKA患者在关键的前4周内经历中度至重度疼痛 TKA术后可能会干扰康复。患者在康复期间无法充分参与 这一时期的风险是恢复正常功能的时间大大延迟，独立性和生活质量下降， 会增加患慢性疼痛的风险。尽管使用多模式疼痛管理，许多患者仍然 经历显著的疼痛，需要与衰弱副作用相关的阿片类药物，干扰 在TKA术后关键的前4周内，先前的I期和II期研究 成功完成，证明经皮周围神经刺激（PNS）可以提供 立即改善术后疼痛和膝关节活动度， 在TKA后的前4周内，与单独标准治疗相比，疼痛和功能改善， TKA术后3个月慢性术后疼痛和阿片类药物使用的发生率较低。 目前IIB期项目的目标是开发和测试一种先进的经皮PNS系统， 可以：将之前I期和II期临床试验中证明的获益转化为常规临床实践 研究，克服这些研究中记录的挑战，并满足设计要求， 由具有广泛技能的医生在麻醉患者中一致且成功地部署 在关键的术后4周康复期间， 窗口，不受现有护理标准的限制。该项目的目标是开发和测试一个多- 接触式开路线圈电极导线，设计用于扩大仅使用解剖结构放置电极导线的目标区域 标志和超声引导，避免测试刺激和评估患者反馈的需要（目标1）; 开发和测试统一的导引器和连接器系统，使单个医生能够快速准确地 在没有帮助的情况下展开电极导线，随后展开电极导线连接器（目标2）;开发并测试外部脉冲 完成系统开发（目标3）;并确定 所提出的系统能够在临床研究中快速准确地放置电极导线（目标4）。成功完成 的目标将导致一种新的经皮PNS系统，准备提交FDA 510（k）许可， 目标是在不同的医疗保健环境中提供相同的疼痛缓解，阿片类药物减少和功能性 在专家研究环境中的先前研究中证明的改进。这种创新的商业化 PNS系统将通过为医生及其患者提供非阿片样物质， 微创，简单，安全，有效的治疗选择，并促进广泛采用， TKA后用于缓解疼痛和改善身体功能的新护理标准，可扩展到家庭 出院后的康复期，以改善功能，独立性和生活质量。