Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients undergoing Total Knee Arthroplasty

摘要 膝关节置换术是美国最常见的选择性手术之一，而且只有 预计会随着人口老龄化而增加。全膝关节置换术(TKA)是治疗股骨头坏死的有效方法。 患有退行性关节疾病或关节炎导致功能受限和持续性疼痛的患者， 最常见的结果是功能和生活质量的改善。然而，一个不是无关紧要的比例 接受全膝关节置换术的患者(高达53%)术后出现慢性术后疼痛(CPSP)。 CPSP不仅给功能和生活质量带来重大后果，而且往往导致 长期阿片类药物治疗和经济负担。CPSP发展的风险因素一直是 确定，其中最具预测性的是先前存在的慢性疼痛；术前慢性阿片类药物的使用； 抑郁；焦虑；以及痛苦带来的灾难。此外，更严重的术后疼痛 与发生CPSP的可能性增加有关，这与假设的中枢疼痛敏化过程有关 这为持续的、在某些情况下放大的慢性疼痛奠定了基础。尽管人们越来越多地了解 这些预测因子在CPSP发生发展中的作用，在此之前很少为高危患者提供 手术以减少这些改变人生结局的发生。提出的是发展和 靶向认知行为疗法(CBT)阿片类药物逐渐减少干预的初步疗效测试 在计划的全膝关节置换术前4周交付，以减轻CPSP的术前风险因素， 减少术后急性疼痛的严重程度，从而降低术后发生CPSP的风险 做手术。具体地说，在患有慢性疼痛的成年男性和女性中，接受阿片类药物治疗并正在接受 将实施一项计划中的TKA，一项随机临床试验，以评估这种新干预的能力 减少手术前慢性疼痛强度、阿片类药物使用、焦虑、抑郁和疼痛灾难 基线将在手术前立即评估，并在手术后的组间差异 72小时疼痛强度和CPSP在3个月和6个月的发生率将随机与 像往常一样治疗。新的干预将基于对现有的、经过验证的计算机的修改- 慢性疼痛的辅助性CBT干预(PAINTrainer)包括激励性访谈阿片类药物逐渐减少 组件。拟议的工作是反映项目的早期概念阶段的发展研究 旨在防止手术后急性疼痛转变为CPSP。预计调查结果将会是 在一种新的、具有成本效益和循证的干预中，将对疼痛结果产生有意义的影响 在关节置换手术后，并准备在随后的随机临床试验中进行测试。在那 CPSP带来了重大的健康后果，包括功能和生活质量下降， 持续使用阿片类药物和直接患者成本，旨在缓解其发展的干预措施至关重要 在临床环境中实施和评估。

ABSTRACT Knee joint replacement is among the most common elective surgeries performed in the United States, and only expected to increase as the population ages. Total knee arthroplasty (TKA) is the definitive treatment for patients suffering degenerative joint disease or arthritis causing limited function and persistent pain, which most often results in improvements in function and quality of life. However, a not inconsequential proportion of patients (up to 53%) undergoing TKA develop chronic post-surgical pain (CPSP) following the procedure. CPSP brings with it significant consequences not only to functionality and quality of life, but often leading to long-term opioid therapy and economic burden. Risk factors for the development of CPSP have been identified, the most predictive of which are pre-existing chronic pain; pre-operative chronic opioid use; depression; anxiety; and pain catastrophizing. In addition, more severe post-operative pain has been linked to the increased likelihood for developing CPSP, due to postulated central pain sensitization processes which set the stage for ongoing and in some cases magnified chronic pain. Despite increased understanding of the role of these predictors in the development of CPSP, little is provided to at-risk patients prior to surgery to mitigate the occurrence of these life-changing outcomes. Proposed is the development and preliminary efficacy testing of a targeted cognitive-behavioral therapy (CBT) opioid taper intervention delivered in the 4 weeks immediately prior to planned TKA to mitigate pre-operative risk factors for CPSP, reduce the severity of acute post-operative pain, and thereby the risk for development of CPSP following surgery. Specifically, in a sample of adult men and women with chronic pain, on opioid therapy and undergoing a planned TKA, a randomized clinical trial will be implemented to evaluate the ability of this novel intervention to decrease pre-operative chronic pain intensity, opioid use, anxiety, depression and pain catastrophizing from baseline will be evaluated immediately prior to the surgical procedure, and group differences in post-operative 72hr pain intensity and incidence of CPSP at 3 and 6 months will be compared subjects randomized to treatment-as-usual. The novel intervention will be based upon modification of an existing, validated computer- assisted CBT intervention for chronic pain (PAINTrainer) to include a motivational interviewing opioid taper component. The proposed work is developmental research reflecting the early, conceptual stage of a project designed to prevent the transition of acute post-surgical pain into CPSP. It is anticipated the findings will result in a novel, cost-effective, and evidence-based intervention that will meaningfully impact pain outcomes following joint replacement surgery, and ready for testing in a subsequent randomized clinical trial. In that CPSP brings with it significant health consequences, including diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting.