Zgierska Aleksandra E, Burzinski Cindy A, Cox Jennifer, Kloke John, Singles Janice, Mirgain Shilagh, Stegner Aaron, Cook Dane B, Bačkonja Miroslav
1 Department of Family Medicine and Community Health, University of Wisconsin-Madison , School of Medicine and Public Health, Madison, WI.
2 Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison , School of Medicine and Public Health, Madison, WI.
J Altern Complement Med. 2016 Aug;22(8):610-20. doi: 10.1089/acm.2015.0314. Epub 2016 Jun 7.
Although mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy.
26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone.
Outpatient.
Adults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer.
Targeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. "Usual care" for opioid-treated CLBP was provided to participants by their regular clinicians.
Feasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants.
Thirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants.
MM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.
尽管正念冥想（MM）越来越多地用于慢性疼痛治疗，但支持其用于阿片类药物治疗的慢性下腰痛（CLBP）临床应用的证据有限。本研究的目的是确定基于MM的干预措施对需要每日阿片类药物治疗的CLBP患者的可行性、可接受性和安全性。
为期26周的试点随机对照试验，比较基于MM的干预措施（联合常规护理）与单纯常规护理。
门诊。
每天接受≥30毫克吗啡当量剂量（MED）治疗3个月或更长时间的CLBP成人患者。
有针对性的基于MM的干预包括在研究期间每周进行8次2小时的小组课程和家庭练习（每天30分钟，每周6天）。阿片类药物治疗的CLBP的“常规护理”由参与者的常规临床医生提供。
通过实验参与者对干预方案的依从性和治疗满意度评估MM干预的可行性和可接受性。通过询问所有研究参与者的副作用/不良事件和阿片类药物剂量评估安全性。
在为期10周的招募期间，35名参与者入组。平均年龄（±标准差）为51.8±9.7岁；患者以女性为主，有严重的CLBP相关疼痛和残疾，每天接受148.3±129.2毫克MED治疗。所有参与者均完成了基线评估；无人错过两次随访评估或退出。在实验参与者（n = 21）中，19人参加了1次或更多次干预课程，14人参加了4次或更多次。在为期26周的研究中，他们平均每周报告164.0±122.1分钟的正式练习，每周报告103.5±111.5分钟的简短非正式练习。17名患者对干预进行了评估，表明满意；他们的定性回答称该课程对疼痛管理（n = 10）和提高疼痛应对技能（n = 8）有用。研究参与者中未发生严重不良事件或安全问题。
基于MM的干预措施在阿片类药物治疗的CLBP中是可行、可接受且安全的。
