不同地理位置的神经纤维瘤病成年患者疼痛干扰情况的改善：一项充分赋权的随机对照试验结果
Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial.
作者信息
Hooker Julia E, Doorley James D, Greenberg Jonathan, Bakhshaie Jafar, Manglani Heena R, Briskin Ellie A, Vranceanu Ana-Maria
机构信息
Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, Massachusetts, USA.
出版信息
Neurooncol Pract. 2024 Sep 20;12(1):58-67. doi: 10.1093/nop/npae084. eCollection 2025 Feb.
BACKGROUND
Pain is prevalent among adults with neurofibromatoses (NF) and hinders quality of life. Pain management for NF is predominantly pharmacological and often ineffective. Psychosocial treatments improve pain outcomes in other chronic illness populations but have not been developed and tested in fully powered efficacy trials among adults with NF. Using data from a fully powered randomized clinical trial of an 8-week mind-body program (Relaxation Response Resiliency Program for NF [3RP-NF]) versus a health education control (HEP-NF), we examined (1) improvements in pain intensity and pain interference, and (2) mechanisms underlying improvements.
METHODS
Participants (210, = 42.6, 73.4% female) were randomized to 3RP-NF versus HEP-NF. They completed measures of pain intensity, pain interference, and putative mechanisms (eg, mindfulness, coping, and social support) at baseline, post-intervention, 6-month, and 12-month follow-ups.
RESULTS
There was a statistically significant change in pain interference over time (3, 537.06) = 7.21, < .001, but not pain intensity. Neither group (3RP-NF vs. HEP-NF) nor the group-by-time interaction predicted change in pain interference. While the group-by-time interaction was not statistically significant across all time points, planned post-hoc analyses probing the interaction at specific time points revealed a statistically significant decrease in pain interference from baseline to post-intervention ( < .001), which was sustained (ie, no subsequent change) from post-intervention through 6-month ( = 1.00) and 12-month follow-ups ( = 1.00) in the 3RP-NF group. The HEP-NF group had no significant changes in pain intensity or interference over time. The association between group (3RP-NF) and decreased pain interference from baseline to post-intervention was fully mediated by change in coping over the same period.
CONCLUSIONS
Participation in the 3RP-NF is associated with sustained improvement in pain interference. Improvement occurred through increased coping.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03406208.
TRIAL REGISTRATION URL
背景
疼痛在患有神经纤维瘤病（NF）的成年人中普遍存在，会影响生活质量。NF的疼痛管理主要依靠药物治疗，且往往效果不佳。心理社会治疗可改善其他慢性病患者的疼痛状况，但尚未在针对成年NF患者的充分有力的疗效试验中得到开发和验证。我们利用一项针对为期8周的身心计划（NF放松反应恢复力计划[3RP-NF]）与健康教育对照（HEP-NF）的充分有力的随机临床试验数据，研究了（1）疼痛强度和疼痛干扰的改善情况，以及（2）改善背后的机制。
方法
参与者（210名，平均年龄=42.6岁，73.4%为女性）被随机分为3RP-NF组和HEP-NF组。他们在基线、干预后、6个月和12个月随访时完成了疼痛强度、疼痛干扰及假定机制（如正念、应对方式和社会支持）的测量。
结果
随着时间推移，疼痛干扰有统计学意义上的显著变化（F(3, 537.06)=7.21，p<.001），但疼痛强度无变化。两组（3RP-NF组与HEP-NF组）及组×时间交互作用均未预测疼痛干扰的变化。虽然组×时间交互作用在所有时间点上无统计学意义，但在特定时间点探究该交互作用的计划事后分析显示，从基线到干预后，3RP-NF组的疼痛干扰有统计学意义上的显著降低（p<.001），且从干预后到6个月（p=1.00）及12个月随访（p=1.00）持续保持（即无后续变化）。HEP-NF组的疼痛强度和干扰随时间无显著变化。从基线到干预后，3RP-NF组与疼痛干扰降低之间的关联完全由同期应对方式的变化介导。
结论
参与3RP-NF与疼痛干扰的持续改善相关。改善是通过增强应对方式实现的。
试验注册
ClinicalTrials.gov标识符：NCT03406208。
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