Schrubbe Leah A, Ravyts Scott G, Benas Bernadette C, Campbell Lisa C, Cené Crystal W, Coffman Cynthia J, Gunn Alexander H, Keefe Francis J, Nagle Caroline T, Oddone Eugene Z, Somers Tamara J, Stanwyck Catherine L, Taylor Shannon S, Allen Kelli D
Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, 3300 Thurston Bldg., CB# 7280, Chapel Hill, NC, 27599, USA.
Department of Medicine, University of North Carolina at Chapel Hill, 125 MacNider Hall CB# 7005, Chapel Hill, NC, 27599, USA.
BMC Musculoskelet Disord. 2016 Aug 23;17(1):359. doi: 10.1186/s12891-016-1217-2.
African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA.
METHODS/DESIGN: This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System.
This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities.
ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.
非裔美国人患骨关节炎（OA）的负担过重，患病率更高，疼痛更严重，功能受限更多。解决这些差异的一个关键障碍是非裔美国人在OA行为干预措施的开发和评估中参与度有限。疼痛应对技能训练（CST）是一种认知行为干预，已显示出改善OA相关疼痛和其他结局的功效。新出现的数据表明，疼痛CST可能是减少OA症状严重程度种族差异的一种有前景的干预措施。然而，这项研究存在重要空白，包括纳入利益相关者的观点（如文化适宜性、临床实践实施策略）以及在患有OA的非裔美国人中专门测试疼痛CST。本研究将评估文化强化疼痛CST项目对患有OA的非裔美国人的有效性。
方法/设计：这是一项针对248名有症状的髋部或膝部OA患者的随机对照试验，将患者平均分配到疼痛CST组和等待名单（WL）对照组。疼痛CST项目纳入了患者和其他利益相关者的反馈，包括11次基于电话的每周课程。在基线、12周（主要时间点）和36周（评估治疗效果的维持情况）进行结局评估。主要结局是西安大略和麦克马斯特大学骨关节炎指数，次要结局包括自我效能感、疼痛应对、疼痛干扰、生活质量、抑郁症状以及总体变化评估。将使用线性混合模型比较疼痛CST组和WL对照组，并探讨参与者特征是否与疼痛CST项目的不同改善情况相关。本研究符合《赫尔辛基宣言》，并获得了北卡罗来纳大学教堂山分校、达勒姆退伍军人事务医疗中心、东卡罗来纳大学和杜克大学健康系统的机构审查委员会的批准。
这个文化强化疼痛CST项目可能对患有OA的非裔美国人的结局产生重大影响，并且可能是减少种族健康差异的关键策略。
ClinicalTrials.gov，NCT02560922，于2015年9月22日注册。
