Dember Laura M, Hsu Jesse Y, Mehrotra Rajnish, Cavanaugh Kerri L, Kalim Sahir, Charytan David M, Fischer Michael J, Jhamb Manisha, Johansen Kirsten L, Becker William C, Pellegrino Bethany, Eneanya Nwamaka D, Schrauben Sarah J, Pun Patrick H, Unruh Mark L, Morasco Benjamin J, Mehta Mansi, Miyawaki Nobuyuki, Penfield Jeffrey, Bernardo Leah, Brintz Carrie E, Cheatle Martin D, Doorenbos Ardith Z, Heapy Alicia A, Keefe Francis J, Krebs Erin E, Kuzla Natalie, Nigwekar Sagar U, Schmidt Rebecca J, Steel Jennifer L, Wetmore James B, White David M, Kimmel Paul L, Cukor Daniel
Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Department of Biostatistics, Epidemiology and Informatics, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia.
JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140.
Chronic pain is common among individuals with dialysis-dependent kidney failure.
To evaluate the effectiveness of pain coping skills training (PCST), a cognitive behavioral intervention, on pain interference.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial of PCST vs usual care was conducted across 16 academic centers and 103 outpatient dialysis facilities in the US. Adults undergoing maintenance hemodialysis and experiencing chronic pain were randomly assigned to PCST or usual care in a 1:1 ratio. Participants were followed in the trial for 36 weeks. Enrollment began on January 4, 2021, and follow-up ended on December 21, 2023.
PCST consisting of 12 weekly coach-led sessions via video or telephone conferencing, followed by 12 weeks of daily interactive voice response sessions. Usual care had no trial-driven pain intervention.
The primary outcome was pain interference measured with the Brief Pain Inventory (BPI) Interference subscale (score range of 0-10, with higher scores indicating more pain interference). Secondary outcomes included pain intensity, pain catastrophizing, quality of life, depression, and anxiety.
A total of 643 participants (mean [SD] age, 60.3 [12.6] years; 288 [44.8%] female) were randomized, with 319 assigned to PCST and 324 assigned to usual care. At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group (between-group difference, -0.49; 95% CI, -0.85 to -0.12; P = .009). The effect persisted at week 24 (between-group difference in BPI Interference score, -0.48; 95% CI, -0.86 to -0.11) but was diminished at week 36 (between-group difference in BPI Interference score, -0.34; 95% CI, -0.72 to 0.04). A decrease in BPI Interference score greater than 1 point (minimal clinically important difference) occurred in 143 of 281 participants (50.9%) in the PCST group vs 108 of 295 participants (36.6%) in the usual care group at 12 weeks (odds ratio, 1.79; 95% CI, 1.28-2.49) and 142 of 258 participants (55.0%) in the PCST group vs 113 of 264 participants (42.8%) in the usual care group at 24 weeks (odds ratio, 1.59; 95% CI, 1.13-2.24). Favorable changes with PCST were also apparent for secondary outcomes of pain intensity, quality of life, depression, and anxiety at weeks 12 and/or 24, as well as for pain catastrophizing at weeks 24 and 36.
In this randomized clinical trial of patients undergoing maintenance hemodialysis, PCST had benefits on pain interference and other pain-associated outcomes. While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants.
ClinicalTrials.gov Identifier: NCT04571619.
慢性疼痛在依赖透析的肾衰竭患者中很常见。
评估疼痛应对技能训练（PCST）这一认知行为干预措施对疼痛干扰的有效性。
设计、地点和参与者：这项PCST与常规护理对比的多中心随机临床试验在美国的16个学术中心和103个门诊透析设施中进行。接受维持性血液透析且患有慢性疼痛的成年人按1:1的比例随机分配至PCST组或常规护理组。参与者在试验中随访36周。招募于2021年1月4日开始，随访于2023年12月21日结束。
PCST包括通过视频或电话会议由教练主导的每周12次课程，随后是为期12周的每日交互式语音回复课程。常规护理没有试验驱动的疼痛干预措施。
主要结局是用简明疼痛量表（BPI）干扰分量表测量的疼痛干扰（评分范围为0 - 10分，分数越高表明疼痛干扰越大）。次要结局包括疼痛强度、疼痛灾难化、生活质量、抑郁和焦虑。
共有643名参与者（平均[标准差]年龄，60.3[12.6]岁；288名[44.8%]为女性）被随机分组，319名被分配至PCST组，324名被分配至常规护理组。在第12周（主要终点）时，PCST组的BPI干扰评分降幅大于常规护理组（组间差异为 - 0.49；95%置信区间， - 0.85至 - 0.12；P = 0.009）。该效果在第24周时持续存在（BPI干扰评分的组间差异为 - 0.48；95%置信区间， - 0.86至 - 0.11），但在第36周时减弱（BPI干扰评分的组间差异为 - 0.34；95%置信区间， - 0.72至0.04）。在第12周时，PCST组281名参与者中有143名（50.9%）的BPI干扰评分下降超过1分（最小临床重要差异），而常规护理组295名参与者中有108名（36.6%）；在第24周时，PCST组258名参与者中有142名（55.0%），常规护理组264名参与者中有113名（42.8%）（优势比，1.79；95%置信区间，1.28 - 2.49）。在第12周和/或第24周时，PCST在疼痛强度、生活质量、抑郁和焦虑等次要结局方面也有明显的有利变化，在第24周和第36周时在疼痛灾难化方面也有有利变化。
在这项针对接受维持性血液透析患者的随机临床试验中，PCST对疼痛干扰和其他与疼痛相关的结局有有益影响。虽然对整个队列的影响程度适中，但该干预措施使相当一部分参与者的疼痛干扰在临床上有意义地改善。
ClinicalTrials.gov标识符：NCT04571619。
