New England Geriatric Research Education and Clinical Center, Section of Palliative Care, VA Boston Healthcare System, Boston, Massachusetts.
Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
JAMA Intern Med. 2024 Sep 1;184(9):1074-1082. doi: 10.1001/jamainternmed.2024.3071.
Chronic pain is a common condition for which efficacious interventions tailored to highly affected populations are urgently needed. People with HIV have a high prevalence of chronic pain and share phenotypic similarities with other highly affected populations.
To evaluate the efficacy of a behavioral pain self-management intervention called Skills to Manage Pain (STOMP) compared to enhanced usual care (EUC).
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included adults with HIV who experienced at least moderate chronic pain for 3 months or more. The study was set at the University of Alabama at Birmingham and the University of North Carolina-Chapel Hill large medical centers from August 2019 to September 2022.
STOMP combined 1-on-1 skill-building sessions delivered by staff interventionists with group sessions co-led by peer interventionists. The EUC control group received the STOMP manual without any 1-on-1 or group instructional sessions.
The primary outcome was pain severity and the impact of pain on function, measured by the Brief Pain Inventory (BPI) summary score. The primary a priori hypothesis was that STOMP would be associated with a decreased BPI in people with HIV compared to EUC.
Among 407 individuals screened, 278 were randomized to STOMP intervention (n = 139) or EUC control group (n = 139). Among the 278 people with HIV who were randomized, the mean (SD) age was 53.5 (10.0) years; 126 (45.0%) identified as female, 146 (53.0%) identified as male, 6 (2.0%) identified as transgender female. Of the 6 possible 1-on-1 sessions, participants attended a mean (SD) of 2.9 (2.5) sessions. Of the 6 possible group sessions, participants attended a mean (SD) of 2.4 (2.1) sessions. Immediately after the intervention compared to EUC, STOMP was associated with a statistically significant mean difference for the primary outcome, BPI total score: -1.25 points (95% CI, -1.71 to -0.78 points; P < .001). Three months after the intervention, the mean difference in BPI total score remained statistically significant, favoring the STOMP intervention -0.62 points (95% CI, -1.09 to -0.14 points; P = .01).
The findings of this randomized clinical trial support the efficaciousness of STOMP as an intervention for chronic pain in people with HIV. Future research will include implementation studies and work to understand the optimal delivery of the intervention.
ClinicalTrials.gov Identifier: NCT03692611.
慢性疼痛是一种常见病症，迫切需要针对高度受影响人群的有效干预措施。艾滋病毒感染者慢性疼痛的患病率很高，并且与其他高度受影响人群具有相似的表型。
评估一种名为“Skills to Manage Pain”（STOMP）的行为疼痛自我管理干预措施与增强型常规护理（EUC）相比的疗效。
设计、地点和参与者：这项随机临床试验纳入了至少有 3 个月或更长时间慢性疼痛中度或以上的艾滋病毒感染者。该研究在阿拉巴马大学伯明翰分校和北卡罗来纳大学教堂山分校的大型医疗中心进行，时间为 2019 年 8 月至 2022 年 9 月。
STOMP 将由工作人员干预者进行的 1 对 1 技能培养课程与由同伴干预者共同领导的小组课程相结合。EUC 对照组接受 STOMP 手册，但没有任何 1 对 1 或小组指导课程。
主要结局是疼痛严重程度和疼痛对功能的影响，通过Brief Pain Inventory（BPI）总结评分来衡量。主要的先验假设是 STOMP 与 EUC 相比，与艾滋病毒感染者的 BPI 下降相关。
在 407 名接受筛查的人中，有 278 人被随机分配到 STOMP 干预组（n = 139）或 EUC 对照组（n = 139）。在随机分配的 278 名艾滋病毒感染者中，平均（标准差）年龄为 53.5（10.0）岁；126 名（45.0%）为女性，146 名（53.0%）为男性，6 名（2.0%）为跨性别女性。在 6 次可能的 1 对 1 课程中，参与者平均（标准差）参加了 2.9（2.5）次课程。在 6 次可能的小组课程中，参与者平均（标准差）参加了 2.4（2.1）次课程。与 EUC 相比，干预后立即，STOMP 在主要结局 BPI 总分方面具有统计学意义的平均差异：-1.25 分（95%CI，-1.71 至-0.78 分；P < 0.001）。干预 3 个月后，BPI 总分的平均差异仍具有统计学意义，STOMP 干预组更有利-0.62 分（95%CI，-1.09 至-0.14 分；P = 0.01）。
这项随机临床试验的结果支持 STOMP 作为艾滋病毒感染者慢性疼痛干预措施的有效性。未来的研究将包括实施研究，并努力了解干预措施的最佳实施方式。
ClinicalTrials.gov 标识符：NCT03692611。
