Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial.

IF 2.4 Q2 CLINICAL NEUROLOGY

Neuro-oncology practice Pub Date : 2024-09-20 eCollection Date: 2025-02-01 DOI:10.1093/nop/npae084

Julia E Hooker, James D Doorley, Jonathan Greenberg, Jafar Bakhshaie, Heena R Manglani, Ellie A Briskin, Ana-Maria Vranceanu

{"title":"Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial.","authors":"Julia E Hooker, James D Doorley, Jonathan Greenberg, Jafar Bakhshaie, Heena R Manglani, Ellie A Briskin, Ana-Maria Vranceanu","doi":"10.1093/nop/npae084","DOIUrl":null,"url":null,"abstract":"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 (N = 210, M age = 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 F(3, 537.06) = 7.21, P < .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 (P < .001), which was sustained (ie, no subsequent change) from post-intervention through 6-month (P = 1.00) and 12-month follow-ups (P = 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: https://clinicaltrials.gov/study/NCT03406208.","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":"12 1","pages":"58-67"},"PeriodicalIF":2.4000,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798604/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neuro-oncology practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/nop/npae084","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

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 (N = 210, M _age = 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 F(3, 537.06) = 7.21, P < .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 (P < .001), which was sustained (ie, no subsequent change) from post-intervention through 6-month (P = 1.00) and 12-month follow-ups (P = 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: https://clinicaltrials.gov/study/NCT03406208.

查看原文本刊更多论文

不同地域成人神经纤维瘤病患者疼痛干扰的改善：一项完全随机对照试验的结果。

背景：疼痛在成人神经纤维瘤（NF）患者中普遍存在，并影响生活质量。NF的疼痛管理主要是药物治疗，而且往往无效。社会心理治疗改善了其他慢性疾病人群的疼痛结局，但尚未在成人NF患者中开发和测试完全有效的疗效试验。利用8周身心计划（NF放松反应-弹性计划[3RP-NF]）与健康教育对照（HEP-NF）的随机临床试验数据，我们检验了(1)疼痛强度和疼痛干扰的改善，以及(2)改善的机制。方法：参与者（N = 210， M年龄= 42.6,73.4%为女性）随机分为3RP-NF组和HEP-NF组。他们在基线、干预后、6个月和12个月的随访中完成了疼痛强度、疼痛干扰和可能的机制（如正念、应对和社会支持）的测量。结果：3RP-NF组疼痛干扰随时间变化（F(3,537.06) = 7.21, P P = 1.00），随访12个月（P = 1.00），差异均有统计学意义。随着时间的推移，HEP-NF组在疼痛强度或干扰方面没有显著变化。从基线到干预后，3RP-NF组与疼痛干扰减少之间的关联完全由同期应对能力的变化介导。结论：参与3RP-NF与疼痛干扰的持续改善有关。改善发生在增加应对。试验注册：ClinicalTrials.gov标识符：NCT03406208。试用注册网址：https://clinicaltrials.gov/study/NCT03406208。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Neuro-oncology practice CLINICAL NEUROLOGY-

CiteScore

5.30

自引率

11.10%

发文量

期刊介绍： Neuro-Oncology Practice focuses on the clinical aspects of the subspecialty for practicing clinicians and healthcare specialists from a variety of disciplines including physicians, nurses, physical/occupational therapists, neuropsychologists, and palliative care specialists, who have focused their careers on clinical patient care and who want to apply the latest treatment advances to their practice. These include: Applying new trial results to improve standards of patient care Translating scientific advances such as tumor molecular profiling and advanced imaging into clinical treatment decision making and personalized brain tumor therapies Raising awareness of basic, translational and clinical research in areas of symptom management, survivorship, neurocognitive function, end of life issues and caregiving