A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain

改善膝骨关节炎疼痛患者预后的序贯策略

• 批准号: 10917533
• 负责人: Claudia Michelle Campbell
• 金额: $ 15.56万
• 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/10917533
• 关键词: Adverse effects; Advocate; Affect; Anti-Inflammatory Agents; Behavior Therapy; Behavioral; Body mass index; Caring; Characteristics; Chronic; Clinical; Cognitive Therapy; Coping Skills; Degenerative polyarthritis; Development; Economic Burden; Effectiveness; Elderly; Exercise; Exhibits; Goals; Guidelines; Hyaluronic Acid; Individual; Injections; Internet; Intervention; Intra-Articular Injections; Joints; Knee Osteoarthritis; Knowledge; Life Expectancy; Local Anesthetics; Measures; Medicine; Mental Depression; Methods; Modeling; Nerve; Nerve Block; Norepinephrine; Operative Surgical Procedures; Opioid; Outcome; Pain; Pain management; Participant; Patient Selection; Patients; Persistent pain; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Phenotype; Physical Function; Population; Prediction of Response to Therapy; Procedures; Public Health; Quality of life; Radiofrequency Interstitial Ablation; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research Personnel; Risk; Role; Selection for Treatments; Self Management; Sequential Treatment; Serotonin; Sleep; Societies; Standardization; Steroids; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Tramadol; chronic pain; clinical pain; comparative effectiveness; compare effectiveness; cost effective; disability; duloxetine; effectiveness evaluation; effectiveness testing; effectiveness trial; evidence based guidelines; experience; functional disability; functional improvement; functional outcomes; global health; impression; improved; improved outcome; inhibitor; innovation; knee pain; knee replacement arthroplasty; model design; multidisciplinary; non-opioid analgesic; opioid sparing; opioid therapy; opioid use; osteoarthritis pain; pain catastrophizing; pain model; pain outcome; pain reduction; pain relief; patient subsets; precision medicine; psychologic; psychosocial; randomized trial; resilience; response; reuptake; skills training; standard of care; telehealth; treatment comparison; treatment response; treatment strategy; Adverse effects; Advocate; Affect; Anti-Inflammatory Agents; Behavior Therapy; Behavioral; Body mass index; Caring; Characteristics; Chronic; Clinical; Cognitive Therapy; Coping Skills; Degenerative polyarthritis; Development; Economic Burden; Effectiveness; Elderly; Exercise; Exhibits; Goals; Guidelines; Hyaluronic Acid; Individual; Injections; Internet; Intervention; Intra-Articular Injections; Joints; Knee Osteoarthritis; Knowledge; Life Expectancy; Local Anesthetics; Measures; Medicine; Mental Depression; Methods; Modeling; Nerve; Nerve Block; Norepinephrine; Operative Surgical Procedures; Opioid; Outcome; Pain; Pain management; Participant; Patient Selection; Patients; Persistent pain; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Phenotype; Physical Function; Population; Prediction of Response to Therapy; Procedures; Public Health; Quality of life; Radiofrequency Interstitial Ablation; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research Personnel; Risk; Role; Selection for Treatments; Self Management; Sequential Treatment; Serotonin; Sleep; Societies; Standardization; Steroids; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Tramadol; chronic pain; clinical pain; comparative effectiveness; compare effectiveness; cost effective; disability; duloxetine; effectiveness evaluation; effectiveness testing; effectiveness trial; evidence based guidelines; experience; functional disability; functional improvement; functional outcomes; global health; impression; improved; improved outcome; inhibitor; innovation; knee pain; knee replacement arthroplasty; model design; multidisciplinary; non-opioid analgesic; opioid sparing; opioid therapy; opioid use; osteoarthritis pain; pain catastrophizing; pain model; pain outcome; pain reduction; pain relief; patient subsets; precision medicine; psychologic; psychosocial; randomized trial; resilience; response; reuptake; skills training; standard of care; telehealth; 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 I) 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.

项目摘要/摘要 膝盖骨关节炎（KOA）是全球慢性疼痛和残疾的主要原因之一，影响了 30％的老年人代表了个人和社会的主要全球健康和经济负担。这 鉴于生活的增加 预期和人口BMI。手术通常用于治疗KOA，但与高率有关 持续的疼痛，不是永久解决方案。已提倡许多非手术疗法 治疗KOA患者的疼痛。但是，独立的保守治疗包括非阿片类药物 药物和关节注射仅提供有限的缓解疼痛和功能改善 OA患者。这导致了该人群中阿片类药物的高度使用率。该提议的总体目标 是进行顺序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理治疗的比较效应（I阶段I） 而且，在非反应者中，非手术程序干预措施的好处（II期）在三个间 相关目标。 AIM 1将评估个人和在线认知行为的有效性 治疗（止痛药）和药理学治疗（Duloxetine）改善KOA的疼痛和功能 与护理标准相比。 AIM 2将确定Genicular神经射频消融（RFA）是否是否 或关节内注射透明质酸和类固醇比局部更有效地改善预后 麻醉神经阻滞或SOC，并帮助确定这些介入治疗的作用 KOA患者疼痛的管理。将为I期治疗失败的患者提供 如果适当的话，阿片类药物用于严重疼痛管理，使我们能够检查这些疼痛的影响 参与者子集中的程序。 AIM 3将测试临床和社会心理表型是否预测 短期和长期治疗反应。我们的研究涉及全面和创新的方法 在这种情况下从未雇用过以前的工作，包括：多学科的调查人员干部 迄今为止进行最大的随机试验，以评估行为，药物治疗和非手术 KOA的程序干预；阶梯护理，阶乘设计模型，允许超过二十多个 配对治疗比较；表型识别响应者并改善每种疗法的选择 （即精密医学），预计将结束结果并减少不必要的干预措施。这 结果将遵循务实的原则，以最大程度地提高提供给利益相关者的信息，将 不仅检查每个测试的干预措施的有效性，而且还提供有意义的信息 关于跨患者关键亚组的有效性。获得的知识将有助于 开发可翻译的治疗策略，用于治疗KOA疼痛患者 阿片类药物的保留作用。