Peripheral nerve stimulation for amputee pain

周围神经刺激治疗截肢者疼痛

• 批准号: 7927085
• 负责人: Joseph Wilder Boggs
• 金额: $ 13.64万
• 依托单位: NDI MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7927085
• 关键词: Activities of Daily Living; Adverse effects; Affect; American; Amputation; Amputees; Brachial plexus structure; Brief Pain Inventory; Chronic; Clinic; Clinical; Communities; Devices; Elbow; Electric Stimulation; Employment; Esthesia; Failure; Future; Goals; Health; Home environment; Human; Implant; Individual; Lead; Life; Limb structure; Lower Extremity; Mental Depression; Methods; Nerve; Neurostimulation procedures of spinal cord tissue; Office Visits; Outpatients; Pain; Paresthesia; Patients; Peripheral Nerve Stimulation; Peripheral Nerves; Persons; Phantom Limb; Phantom Limb Pain; Pharmaceutical Preparations; Phase; Physiologic pulse; Procedures; Publishing; Quality of life; Reporting; Residual state; Resistance; Risk; Screening procedure; Staging; Stimulus; System; Testing; Time; Transcutaneous Electric Nerve Stimulation; United States; Upper Extremity; Vertebral column; Work; addiction; base; chronic pain; clinically significant; compliance behavior; disability; experience; implantation; migration; minimally invasive; patient population; phase 1 study; phase 2 study; post-amputation pain; prevent; research study; success

DESCRIPTION (provided by applicant): Almost all amputees have pain related to their amputation and most of them have phantom pain and residual limb (stump) pain. These chronic conditions can lead to depression, disability, general suffering, and a reduced quality of life. Over 1.7 million Americans are living with an amputation and over 185,000 more Americans have an amputation each year. The present treatments for stump and phantom pain are unsatisfactory. In amputees with moderate to severe stump and phantom pain, it is typically the pain following amputation instead of the loss of a limb that most limits the activities of daily living, makes the completion of simple tasks difficult, and prevents the return to employment. The long-term goal of this project is to develop and commercialize an implantable neurostimulation product to reduce stump and phantom pain in amputees. We propose to relieve pain through electrical stimulation of the peripheral nerves (PN) innervating the painful stump and phantom regions. The proposed approach is supported by previous studies on electrical stimulation of the PN to reduce post-amputation pain, which demonstrated efficacy but identified the delivery method as the limiting factor in clinical success. If percutaneous stimulation can reduce stump and phantom pain in the present (phase I) in-office study then it will justify a future (phase II) 2-staged home trial in which the amputee patients are sent home with a percutaneous system for 1 week and patients who experience sustained pain relief over the 1-week period will receive a fully implanted system that will be evaluated over the following 12 months. The specific aims of this phase I project are to determine the feasibility of using a percutaneous lead in upper-extremity amputees to 1) generate comfortable stimulation-evoked sensations (paresthesias) in the painful region and reduce 2) stump pain and 3) phantom pain. The hypothesis is that percutaneous stimulation will 1) activate the PN and generate paresthesias in the regions of pain in the stump and the phantom limb and reduce 2) stump pain and 3) phantom pain. This hypothesis will be tested in humans with post-amputation pain by 1) asking the subjects to report if stimulation generates sensation in the regions of pain in the stump and phantom limb and by recording the subject's 2) stump pain and 3) phantom pain on the 0-10 point numerical rating scale of the brief pain inventory short form at baseline and during stimulation to determine if their stump and phantom pain are significantly reduced during stimulation. At the conclusion of this phase I project, we will have determined the feasibility of using percutaneous stimulation to stimulate the PN and reduce stump and phantom pain in amputee patients. If phase I demonstrates feasibility in the office setting, phase II will determine if application of this therapy can be extended to the home environment. PUBLIC HEALTH RELEVANCE: Approximately 1.7 million persons in the United States are living with amputations and the majority of them have stump pain and phantom pain, which are often severe and lead to disability, depression, and general suffering. Stump and phantom pain can greatly reduce quality of life and interfere with the simple activities of daily living, but none of the present treatment options are adequate in managing the pain. The goal of this study is to determine if stump pain and phantom pain can be reduced with percutaneous electrical stimulation of a peripheral nerve in upper-extremity amputees.

描述（由申请人提供）：几乎所有截肢者都有与截肢相关的疼痛，其中大多数人有幻痛和残肢（残端）疼痛。这些慢性病可导致抑郁、残疾、一般痛苦和生活质量下降。超过170万美国人生活在截肢手术中，每年有超过185，000名美国人截肢。目前残端痛和幻肢痛的治疗方法不能令人满意。在患有中度至重度残端和幻肢痛的截肢者中，通常是截肢后的疼痛，而不是肢体的丧失，这限制了日常生活的活动，使简单的任务难以完成，并阻止返回就业。该项目的长期目标是开发和商业化植入式神经刺激产品，以减少截肢者的残肢和幻痛。我们建议通过电刺激支配疼痛残端和幻肢区域的周围神经（PN）来缓解疼痛。提出的方法得到了先前关于电刺激PN以减少截肢后疼痛的研究的支持，这些研究证明了有效性，但将输送方法确定为临床成功的限制因素。如果经皮刺激可以减少目前（I期）门诊研究中的残肢和幻肢疼痛，则将证明未来（II期）2阶段家庭试验是合理的，在该试验中，截肢患者被送回家接受经皮系统治疗1周，在1周内持续疼痛缓解的患者将接受完全植入的系统，并在随后的12个月内进行评价。该I期项目的具体目的是确定在上肢截肢者中使用经皮电极导线的可行性，以1）在疼痛区域产生舒适的刺激诱发感觉（感觉异常），并减少2）残端疼痛和3）幻痛。假设经皮刺激将1）激活PN并在残肢和幻肢疼痛区域产生感觉异常，并减少2）残肢疼痛和3）幻肢疼痛。将通过以下方式在患有截肢后疼痛的人类中测试该假设：1）要求受试者报告刺激是否在残肢和幻肢的疼痛区域中产生感觉，并通过记录受试者的2）残肢疼痛和3）幻肢疼痛，在基线和刺激期间，使用简明疼痛量表简表的10点数字评定量表，以确定其残端和幻肢疼痛是否在刺激过程中明显减少。在第一阶段项目结束时，我们将确定使用经皮刺激来刺激PN并减少截肢患者的残端和幻肢疼痛的可行性。如果第一阶段证明在办公室环境中的可行性，第二阶段将确定这种疗法的应用是否可以扩展到家庭环境。公共卫生相关性：在美国，大约有170万人患有截肢，其中大多数人患有残端疼痛和幻痛，这些疼痛通常很严重，并导致残疾，抑郁和一般痛苦。残肢痛和幻肢痛可以大大降低生活质量，干扰日常生活的简单活动，但目前的治疗方案都不足以控制疼痛。本研究的目的是确定是否可以减少残肢疼痛和幻肢疼痛的周围神经经皮电刺激上肢截肢者。