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慢性疼痛的时间生物学控制的纵向多中心研究:CircaHealth CircaPain 研究方案。

Longitudinal multisite study of the chronobiological control of chronic pain: the CircaHealth CircaPain study protocol.

机构信息

Department of Biomedical and Molecular Sciences, Queen's University, Kingston, Ontario, Canada

Department of Biomedical and Molecular Sciences, Queen's University, Kingston, Ontario, Canada.

出版信息

BMJ Open. 2024 Jun 3;14(6):e086801. doi: 10.1136/bmjopen-2024-086801.

DOI:10.1136/bmjopen-2024-086801
PMID:38830738
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11149164/
Abstract

INTRODUCTION

One in five Canadians lives with chronic pain. Evidence shows that some individuals experience pain that fluctuates in intensity following a circadian (24-hour) rhythm. Endogenous molecular rhythms regulate the function of physiological processes that govern pain mechanisms. Addressing chronic pain rhythmicity on a molecular and biopsychosocial level can advance understanding of the disease and identify new treatment/management strategies. Our CircaHealth CircaPain study uses an online survey combined with ecological momentary assessments and biosample collection to investigate the circadian control of chronic pain and identify potential biomarkers. Our primary objective is to understand interindividual variability in pain rhythmicity, by collecting biopsychosocial measures. The secondary objective accounts for seasonal variability and the effect of latitude on rhythmicity.

METHODS AND ANALYSIS

Following completion of a baseline questionnaire, participants complete a series of electronic symptom-tracking diaries to rate their pain intensity, negative affect, fatigue and stress on a 0-10 scale at 8:00, 14:00 and 20:00 daily over 10 days. These measures are repeated at 6 and 12 months postenrolment to account for potential seasonal changes. We aim to recruit ≥2500 adults with chronic pain within Canada. Infrastructure is being developed to facilitate the collection of blood samples from subgroups of participants (~800) two times per day over 24-48 hours to identify rhythmic expression of circulating genes and/or proteins.

ETHICS AND DISSEMINATION

Ethical approval for this study was obtained by the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (File No. 6038114). Participants provide informed consent to participate, and their data will not be identifiable in any publication or report. Findings will be published in a relevant scientific journal and disseminated at scientific meetings and online webinars. We maintain a website to post updated resources and engage with the community. We employ knowledge mobilisation in the form of direct data sharing with participants.

摘要

简介

五分之一的加拿大人患有慢性疼痛。有证据表明,有些人的疼痛强度会随昼夜节律(24 小时)变化而波动。内源性分子节律调节控制疼痛机制的生理过程的功能。从分子、生物心理社会层面解决慢性疼痛的节律性问题,可以深入了解疾病,并确定新的治疗/管理策略。我们的 CircaHealth CircaPain 研究使用在线调查结合生态瞬时评估和生物样本采集,来研究慢性疼痛的昼夜节律控制,并确定潜在的生物标志物。我们的主要目标是通过收集生物心理社会测量数据,了解个体间疼痛节律性的差异。次要目标是考虑季节性变化和纬度对节律性的影响。

方法和分析

完成基线问卷后,参与者完成一系列电子症状跟踪日记,每天在 8:00、14:00 和 20:00 时以 0-10 分的等级评估他们的疼痛强度、负性情绪、疲劳和压力,共 10 天。在入组后 6 个月和 12 个月重复这些测量,以考虑潜在的季节性变化。我们的目标是在加拿大招募≥2500 名患有慢性疼痛的成年人。正在开发基础设施,以便每天两次在 24-48 小时内从亚组参与者(约 800 人)中采集血液样本,以确定循环基因和/或蛋白质的节律表达。

伦理与传播

这项研究已获得皇后大学健康科学和附属医院研究伦理委员会的批准(档案号 6038114)。参与者提供知情同意书参与研究,其数据在任何出版物或报告中都无法识别。研究结果将发表在相关科学期刊上,并在科学会议和在线网络研讨会上进行传播。我们维护一个网站,发布更新的资源并与社区互动。我们通过直接与参与者共享数据来进行知识转化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/172e/11149164/639a864c5290/bmjopen-2024-086801f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/172e/11149164/639a864c5290/bmjopen-2024-086801f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/172e/11149164/639a864c5290/bmjopen-2024-086801f01.jpg

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