Increasing Participant Diversity in a 'Sequenced-Strategy to Improve Outcomes in people with Knee Osteoarthritis Pain (SKOAP)

增加“改善膝骨关节炎疼痛患者预后的顺序策略”(SKOAP) 的参与者多样性

• 批准号: 10400316
• 负责人: Claudia Michelle Campbell
• 金额: $ 52.38万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400316
• 关键词: Advocate; Affect; Behavioral; Body mass index; Caring; Clinical; Cognitive Therapy; Development; Economic Burden; Effectiveness; Elderly; Goals; Hyaluronic Acid; Individual; Injections; Intervention; Intra-Articular Injections; Joints; Knee Osteoarthritis; Knowledge; Life Expectancy; Local Anesthetics; Nerve; Nerve Block; Operative Surgical Procedures; Opioid; Outcome; Pain; Pain management; Participant; Patient Selection; Patients; Persistent pain; Pharmacological Treatment; Pharmacotherapy; Phase; Phenotype; Population; Procedures; Public Health; Radiofrequency Interstitial Ablation; Randomized Controlled Trials; Research Personnel; Role; Selection for Treatments; Societies; Steroids; Testing; Therapeutic; chronic pain; comparative effectiveness; disability; duloxetine; effectiveness evaluation; effectiveness trial; evidence based guidelines; functional improvement; global health; improved; improved outcome; innovation; model design; multidisciplinary; non-opioid analgesic; opioid sparing; opioid use; osteoarthritis pain; pain reduction; pain relief; patient subsets; precision medicine; psychosocial; randomized trial; standard of care; treatment comparison; treatment response; treatment strategy

PROJECT SUMMARY/ABSTRACT Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults and represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population BMI. Surgery is often employed to treat KOA, but it associated with a high rate of persistent pain, and is not a permanent solution. Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA. However, stand-alone conservative treatments including non-opioid medications and joint injections provide only limited pain relief and functional improvement in a subset of knee OA sufferers. This has led to a high rate of opioid use in this population. The overarching goal of this proposal is to conduct a sequential parallel group randomized controlled trial (RCT) to rigorously evaluate the comparative-effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among non-responders, the benefits of nonsurgical procedural interventions (Phase II) in three inter- related Aims. Aim 1 will evaluate the effectiveness of individual and combined online cognitive behavioral therapy (PainTRAINER) and pharmacologic treatment (duloxetine) in improving pain and function for KOA patients compared to standard of care. Aim 2 will determine if genicular nerve radiofrequency ablation (RFA) or intra-articular injection of hyaluronic acid and steroid are more effective in improving outcomes than local anesthetic nerve block or SOC and help establish the role of these interventional treatments in the overall management of pain in KOA patients. Patients that have failed Phase I treatment will be provided with an opioid for severe pain management, if appropriate, allowing us to examine the opioid-sparing effects of these procedures in a subset of participants. Aim 3 will test whether clinical and psychosocial phenotypes predict short- and long-term treatment response. Our study involves comprehensive and innovative approaches that have never before been employed in this context, including: a multidisciplinary cadre of investigators conducting the largest randomized trial to date evaluating behavioral, pharmacotherapy and nonsurgical procedural interventions for KOA; a stepped-care, factorial design model that allows for more than two dozen pair-wise treatment comparisons; phenotyping to identify responders and improve selection for each therapy (i.e. precision medicine), which is expected to refine outcomes and reduce unnecessary interventions. The results, which will follow pragmatic principles in order to maximize the information provided to stakeholders, will examine not only the effectiveness of each tested intervention but also provide meaningful information regarding effectiveness across key subgroups of patients. The knowledge gained will contribute to the development of translatable therapeutic strategies for the treatment of patients with KOA pain that will lead to opioid sparing effects.

项目概要/摘要 膝骨关节炎 (KOA) 是全世界慢性疼痛和残疾的主要原因之一，影响超过 30% 的老年人，对个人和社会构成了重大的全球健康和经济负担。这 过去 70 年来，KOA 的发病率增加了一倍多，而且随着寿命的延长，KOA 的发病率继续急剧增长 预期和人口体重指数。手术常用于治疗 KOA，但手术发生率较高 持续的疼痛，并不是永久的解决办法。许多非手术疗法被提倡 治疗 KOA 患者的疼痛。然而，包括非阿片类药物在内的独立保守治疗 药物和关节注射只能有限地缓解膝关节的疼痛并改善功能 骨关节炎患者。这导致该人群中阿片类药物的使用率很高。本提案的总体目标 是进行连续平行组随机对照试验（RCT）以严格评估 保守行为和非阿片类药物治疗的疗效比较（第一阶段） 在无反应者中，非手术程序干预（第二阶段）在三个方面的好处 相关目标。目标 1 将评估个人和组合在线认知行为的有效性 治疗（PainTRAINER）和药物治疗（度洛西汀）可改善 KOA 的疼痛和功能 患者与标准护理相比。目标 2 将确定是否进行膝神经射频消融 (RFA) 或 关节内注射透明质酸和类固醇比局部注射更能有效改善结果 麻醉神经阻滞或 SOC 并帮助确定这些介入治疗在整体治疗中的作用 KOA 患者的疼痛管理。第一阶段治疗失败的患者将获得 阿片类药物用于严重疼痛管理（如果合适），使我们能够检查这些药物的阿片类药物节约效果 一部分参与者中的过程。目标 3 将测试临床和心理社会表型是否可以预测 短期和长期治疗反应。我们的研究涉及全面和创新的方法 以前从未在这种情况下受聘过，包括： 一支多学科的调查人员队伍 进行迄今为止最大规模的随机试验，评估行为、药物疗法和非手术疗法 KOA 的程序干预；阶梯式护理、因子设计模型，允许超过两打 成对治疗比较；表型分析以识别应答者并改进每种疗法的选择 （即精准医疗），预计将改善结果并减少不必要的干预。这 结果将遵循务实原则，以便最大限度地向利益攸关方提供信息， 不仅检查每个测试干预措施的有效性，还提供有意义的信息 关于关键患者亚组的有效性。所获得的知识将有助于 开发可转化的治疗策略来治疗 KOA 疼痛患者，这将导致 阿片类药物的节约作用。