Electrical stimulation to reduce pain and improve function after knee replacement

 描述（由申请人提供）：本项目的目的是评价一种新型外周神经刺激疗法治疗疼痛并实现全膝关节置换术后早期康复的可行性（I期）并证明其安全性和有效性（II期）（即，更换），从而改善功能，独立性和生活质量。全膝关节置换术是一种治疗膝关节残疾的外科手术，大约一半的患者在手术后的前四周内经历中度至重度疼痛，这可能会干扰康复。阿片类药物具有使人衰弱的副作用的风险， 康复活动.神经阻滞不适合在家中长期使用，因为有感染、局部麻醉剂毒性和运动阻滞导致的福尔斯跌倒的风险。对于全膝关节置换术后的派，需要非阿片类药物治疗，使患者在术后前4周内充分参与身体康复。在此期间不能完全参与康复的患者有可能严重延迟恢复正常功能。 在I期研究中，将在一项病例系列研究中评价提供即时疼痛缓解和功能改善的可行性，该研究包括16名全膝关节置换术后疼痛和膝关节活动度减少的患者。电刺激将被递送到支配疼痛区域的神经，目的是唤起舒适的感觉，而没有不必要的运动激活。目的是确定刺激是否能立即减轻疼痛，增加膝关节活动范围，并改善活动性。如果所有目标都取得成功，将进行第二阶段的研究。在第二阶段，我们的方法，以减轻疼痛和改善功能，在关键的四周后全膝关节置换术将进行评估，随机安慰剂对照试验招募40个人计划接受手术。术前将经皮电极导线置入每例受试者体内，术后将输送主动刺激（治疗组）或假（安慰剂）刺激（对照组）4周。II期旨在确定治疗组（与对照组相比）是否具有1）行走时疼痛的显著更大减轻，2）膝关节功能、独立性和生活质量的显著改善，以及3）耐力和活动性的显著改善。如果II期试验成功，那么这些数据将支持FDA 510k批准该辅助技术，以改善全膝关节置换术后患者的功能、独立性和生活质量。 我们的新型周围神经刺激疗法的商业化将通过为外科医生及其患者提供非阿片类、微创、简单、安全和有效的治疗选择，从而显著影响临床实践，从而缓解疼痛并改善身体功能，并延伸到出院后的家庭康复期，使患者能够充分参与康复并实现更大的活动性和独立性。

 DESCRIPTION (provided by applicant): The goal of this project is to evaluate the feasibility (Phase I) and demonstrate the safety and effectiveness (Phase II) of a novel peripheral nerve stimulation therapy to treat pain and enable early rehabilitation after total knee arthroplasty (i.., replacement), resulting in improved function, independence, and quality of life. Total knee arthroplasty is a surgical procedure to treat disabling knee conditions, and approximately half of all patients experience moderate to severe pain during the first four weeks after surgery that can interfere with rehabilitation. Opioids carry risks of debilitating side effects that interfere with rehabilitation. Nerve blocks are not suited for extended use at home due to risks of infection, local anesthetic toxicity, and falls from motor block. A non-opioid therapy that enables patients to engage fully in physical rehabilitation during the first 4 weeks after surgery is needed for pai after total knee arthroplasty. Patients who are unable to engage fully in rehabilitation during thi period risk substantial delays in returning to normal function. In Phase I, the feasibility of providing immediate pain relief and improvements in function will be evaluated during in a case series study of 16 individuals suffering from postoperative pain and reduced knee range of motion following total knee arthroplasty. Electrical stimulation will be delivered to the nerve innervating the region of pain with the goal of evoking comfortable sensations without unwanted motor activation. The aims are to determine if stimulation generates immediate reductions in pain, increases knee range of motion, and improves mobility. If all aims are successful, Phase II of the research will be conducted. In Phase II, our approach to relieve pain and improve function during the critical four weeks following total knee arthroplasty will be evaluated in a randomized placebo-controlled trial enrolling 40 individuals scheduled to undergo surgery. A percutaneous lead will be placed preoperatively in each subject, and active stimulation (Treatment Group) or sham (placebo) stimulation (Control Group) will be delivered for four weeks after surgery. The Phase II aims are to determine if the Treatment Group (compared to the Control Group) has 1) significantly greater reductions in pain while walking, 2) significantly improved knee function, independence, and quality of life, and 3) significantly improved endurance and mobility. If Phase II is successful, then these data will support FDA 510k clearance for this assistive technology to improve function, independence, and quality of life of patients following total knee arthroplasty. The commercialization of our novel peripheral nerve stimulation therapy will substantially impact clinical practice by providing surgeons and their patients with a non-opioid, minimally-invasive, simple, safe, and effective treatment option, resulting in pain relief and improved physical function that extends into the post- discharge home rehabilitation period, enabling full participation in rehabilitation and achievement of greater mobility and independence.