tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

tDCS 结合简短的认知干预可减少退伍军人围手术期疼痛和阿片类药物需求

• 批准号: 10417011
• 负责人: Jeffrey J Borckardt
• 金额: --
• 依托单位: RALPH H JOHNSON VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10417011
• 关键词: Acute Pain; Acute pain management; Age; Analgesics; Area; Arthritis; Behavioral; Behavioral Sciences; Brain; Clinical Trials; Cognition; Cognitive; Cognitive Therapy; Confusion; Controlled Study; Data; Development; Drug Delivery Systems; Drug Interactions; Electricity; Fatigue; Health Personnel; Healthcare; Hour; Human; Intervention; Laboratory Study; Lead; Length of Stay; Methods; Modernization; Morbidity - disease rate; Narcotics; Neurosciences; Operative Surgical Procedures; Opioid; Opioid Analgesics; Orthopedic Procedures; Orthopedic Surgery; Outcome; Pain; Pain management; Participant; Patients; Pattern; Perioperative; Persistent pain; Pharmaceutical Preparations; Physical therapy; Pilot Projects; Population; Postoperative Complications; Postoperative Pain; Postoperative Period; Practice Management; Prefrontal Cortex; Prevalence; Procedures; Psyche structure; Quality of life; Recovery; Regimen; Reporting; Risk; Series; Solid; Stomach; Techniques; Technology; Time; Transcranial magnetic stimulation; Ventilatory Depression; Veterans; Work; addiction; cell motility; chronic pain management; cognitive benefits; effective therapy; functional status; improved; innovation; knee pain; knee replacement arthroplasty; minimal risk; mortality; neural circuit; novel; opioid epidemic; opioid misuse; opioid use; pain reduction; pain relief; prescription opioid; side effect; surgery outcome; treatment effect

The proper control of pain is one of the most important areas in health care. We still rely heavily on opioid narcotics for acute and chronic pain control despite growing evidence of their risks and lack of strong efficacy. In surgical populations, where opioid prescribing is common and often believed to be good practice, the amount and duration of post-operative opioid prescriptions are strongly related to subsequent opioid misuse, and perioperative opioid use is associated with increased morbidity and mortality. Total knee arthroplasty (TKA) is one of the most common orthopaedic procedures performed. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks. Data suggest that adequate post-operative pain control in this population is an important factor in determining surgical outcomes, recovery time, and hospital length of stay. While the technology associated with the TKA procedure itself has developed rapidly in the past several years, post-operative pain management techniques have not changed substantially in several decades, and despite the currently employed pain-management strategies, patients still report considerable post-operative pain, and often struggle to complete post-operative physical therapy regimens. New analgesic strategies are needed that can be used adjunctively with existing strategies that have the potential to reduce reliance on opioid analgesia, and reduce post-operative pain. Several novel brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions including perioperative pain. In a series of recent studies, the PI has shown that tDCS can reduce post-operative opioid use by as much as 43% while simultaneously reducing subjective pain ratings. This recent scientific work (and the work of others) suggests that stimulating pain-modulating areas of the human cortex with tDCS has the potential to yield meaningful analgesic effects and reduce post-operative opioid consumption with minimal risks or side-effects. Another non-pharmacologic approach to pain-management with minimal risks and good potential benefit is cognitive behavioral therapy for pain (CBT-P). CBT-P has consistently demonstrated solid empirical support as an effective treatment for chronic pain, but it is less well-studied in perioperative settings. Nonetheless, a few small studies have demonstrated that brief cognitive-behavioral interventions hold promise as adjunctive post- operative pain management strategies, but more work is needed. Interestingly, accumulating data from our group suggest that tDCS of the prefrontal cortex may augment the analgesic effects of cognitive-behavioral (CB) interventions for acute pain. When combined with a brief cognitive-behavioral intervention for acute pain, tDCS appears to enhance the analgesic benefits of the cognitive-behavioral intervention while improving participants’ subjective capacity to benefit from it. It appears that tDCS may be able to prime neural circuits that facilitate engagement of brain areas involved with pain-reducing cognitions and behavioral patterns. Thus, when cognitive-behavioral pain management strategies are taught to patients during tDCS, more analgesic benefit is observed than with either intervention alone. To date, no studies to date have directly investigated analgesic benefits of combining these approaches in the post-operative arena. The proposed study will be the first ever to (1) determine the independent effects of post-operative tDCS and a brief cognitive-behavioral intervention on post-operative pain, opioid use and functioning following TKA, (2) determine the effects of combining tDCS with a brief cognitive-behavioral intervention, and (3) determine longer-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain, opioid use, quality of life, and functioning in TKA patients. This innovative, high-quality clinical trial has the potential to generate findings that could shift the modern paradigm of post-operative pain management to take advantage of recent neuroscience and behavioral-science developments.

正确控制疼痛是医疗保健中最重要的领域之一。我们仍然严重依赖阿片类药物 尽管越来越多的证据表明其风险和缺乏强大的疗效，但麻醉剂用于急性和慢性疼痛控制。 在手术人群中，阿片类药物处方很常见，通常被认为是良好的做法， 术后阿片类药物处方的数量和持续时间与随后的阿片类药物滥用密切相关， 围手术期阿片类药物的使用与发病率和死亡率的增加有关。全膝关节置换 (TKA)是最常见的骨科手术之一。虽然膝盖疼痛通常是一种抱怨， 在TKA之前，手术本身与持续数天至数周的相当大的术后疼痛相关。 数据表明，在这一人群中，充分的术后疼痛控制是决定 手术结果、恢复时间和住院时间。虽然与TKA相关的技术 手术本身在过去几年中发展迅速，术后疼痛管理技术 几十年来没有发生实质性的变化，尽管目前采用的疼痛管理 尽管采用了这些策略，但患者仍然报告有相当大的术后疼痛，并且通常难以完成术后 物理治疗方案需要新的镇痛策略，可以与现有的 有可能减少对阿片类镇痛药的依赖并减少术后疼痛的策略。 包括经颅直流电刺激（tDCS）在内的几种新型脑刺激技术， 开始显示出作为各种疼痛状况（包括围手术期疼痛）的治疗的前景。在 最近的一系列研究表明，tDCS可以减少术后阿片类药物的使用， 43%，同时降低主观疼痛评分。最近的科学工作（以及其他人的工作） 表明用tDCS刺激人类皮层的疼痛调节区域有可能产生 有意义的镇痛作用，减少术后阿片类药物的消耗，风险或副作用最小。 另一种风险最小、潜在获益良好的非药物性疼痛管理方法是 疼痛认知行为疗法（CBT-P）CBT-P一贯表现出坚实的经验支持， 是慢性疼痛的有效治疗方法，但在围手术期的研究较少。尽管如此， 小规模的研究表明，简短的认知行为干预有望成为预防性的事后干预， 手术疼痛管理策略，但需要更多的工作。有趣的是，从我们的数据中积累数据， 研究表明，前额叶皮层的tDCS可能会增强认知行为的镇痛作用。 (CB)急性疼痛的干预措施。当与短暂的认知行为干预相结合时， 疼痛，tDCS似乎增强了认知行为干预的镇痛效果， 提高参与者从中受益的主观能力。tDCS似乎能够启动 神经回路，促进参与减轻疼痛的认知和行为的大脑区域的参与 模式.因此，当在tDCS期间向患者教授认知行为疼痛管理策略时， 观察到比单独使用任何一种干预更大的镇痛益处。迄今为止，没有任何研究直接 研究了在术后竞技场中结合这些方法的镇痛益处。拟议 这项研究将是有史以来第一次（1）确定术后tDCS的独立影响， 对TKA术后疼痛、阿片类药物使用和功能的认知行为干预，（2） 确定tDCS与简短的认知行为干预相结合的效果，以及（3）确定 术后tDCS的长期结果和对疼痛，阿片类药物使用， TKA患者的生活质量和功能。这项创新的高质量临床试验有可能 产生的发现，可以改变手术后疼痛管理的现代范式， 最近神经科学和行为科学的发展。