Cerebral mechanism of Tuina analgesia in management of knee osteoarthritis using multimodal MRI: study protocol for a randomised controlled trial.
Cerebral mechanism of Tuina analgesia in management of knee osteoarthritis using multimodal MRI: study protocol for a randomised controlled trial.
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膝关节骨性关节炎（KOA）患者的慢性疼痛严重影响其生活质量，给社会和经济带来沉重负担。推拿作为一种传统中医的非药物疗法，被公认为是安全有效的缓解KOA慢性疼痛的方法。然而，推拿改善KOA疼痛的潜在中枢机制尚未完全了解。本研究将是一项平行组设计的随机对照试验。共60名合格受试者将以1：1的比例分配到推拿组或健康教育组（教育组），采用分层随机分配，以性别和年龄为因素。两组干预均为30 min/次，每周2次，共12周。本研究将主要关注通过检测推拿治疗引起的脑灰质（GM）结构、白色物质（WM）结构和脑功能连接（FC）的变化来评估疼痛评估，例如，丘脑、海马、前扣带回、S1、中脑导水管周围灰质亚区（PAG）。两组患者将通过临床评估和多模式磁共振成像（MRI）进行评价，以观察基线和6周和12周治疗结束时参与者的GM、WM和FC的变化，并在48周随访期间仍通过临床评估进行评价，但不进行MRI。当前疼痛的视觉模拟量表是主要结局。将分别使用麦吉尔疼痛问卷简表、西安大略和麦克马斯特大学骨关节炎指数、36项健康调查简表、汉密尔顿抑郁量表和汉密尔顿焦虑量表评价疼痛强度、疼痛感觉、疼痛情绪、临床症状和生活质量。MRI评估、临床数据评价者、数据管理者和统计学家将对结局评价程序和数据分析中的组分配设盲，以降低偏倚风险。重复测量方差分析（2组× 6个时间点ANOVA）将用于分析研究中获得的临床和神经影像学数据的数值变量。P<0.05为统计学显著性水平。本随机对照临床试验结合多模式MRI的结果将有助于揭示推拿治疗对KOA患者大脑皮层和皮层下结构潜在形态学改变、白色物质完整性、脑区功能活动和连通性的影响，为推拿治疗KOA的临床应用提供科学依据。中国临床试验注册中心ChiCTR 2000037966。2020年9月8日注册。研究结果将发表在同行评审的期刊上，并通过研究网站和会议传播。
The chronic pain of patients with knee osteoarthritis (KOA) seriously affects their quality of life and leads to heavy social and economic burden. As a nondrug therapy in Traditional Chinese Medicine (TCM), Tuina is generally recognised as safe and effective for reducing the chronic pain of KOA. However, the underlying central mechanisms of Tuina for improving the pain of KOA are not fully understood. This study will be a randomised controlled trial with a parallel-group design. A total of 60 eligible participants will be assigned to the Tuina group or healthcare education group (Education group) at 1:1 ratio using stratified randomisation with gender and age as factors. The interventions of both groups will last for 30 min per session and be conducted twice each week for 12 weeks. This study will primarily focus on pain evaluation assessed by detecting the changes in brain grey matter (GM) structure, white matter (WM) structure, and the cerebral functional connectivity (FC) elicited by Tuina treatment, e.g., thalamus, hippocampus, anterior cingulate gyrus, S1, insula, and periaqueductal grey subregions (PAG). The two groups of patients will be evaluated by clinical assessments and multimodal magnetic resonance imaging (MRI) to observe the alterations in the GM, WM, and FC of participants at the baseline and the end of 6 and 12 weeks’ treatment and still be evaluated by clinical assessments but not MRI for 48 weeks of follow-up. The visual analogue scale of current pain is the primary outcome. The Short-Form McGill Pain Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, 36-Item Short Form Health Survey, Hamilton Depression Scale, and Hamilton Anxiety Scale will be used to evaluate the pain intensity, pain feeling, pain emotion, clinical symptoms, and quality of life, respectively. MRI assessments, clinical data evaluators, data managers, and statisticians will be blinded to the group allocation in the outcome evaluation procedure and data analysis to reduce the risk of bias. The repeated measures analysis of variance (2 groups × 6 time points ANOVA) will be used to analyse numerical variables of the clinical and neuroimaging data obtained in the study. P<0.05 will be the statistical significance level. The results of this randomised controlled trial with clinical assessments and multimodal MRI will help reveal the influence of Tuina treatment on the potential morphological changes in cortical and subcortical brain structures, the white matter integrity, and the functional activities and connectivity of brain regions of patients with KOA, which may provide scientific evidence for the clinical application of Tuina in the management of KOA. Chinese Clinical Trial Registry ChiCTR2000037966. Registered on Sep. 8, 2020. The results will be published in peer-reviewed journals and disseminated through the study’s website, and conferences.
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影响因子：
3.3
作者：
Bezalel, Tomer;Carmeli, Eli;Katz-Leurer, Michal
通讯作者：
Katz-Leurer, Michal
影响因子：
2.3
作者：
Bedson, John;Croft, Peter R.
通讯作者：
Croft, Peter R.
DOI：
10.1016/j.bpa.2020.06.006
发表时间：
2020-09-01
影响因子：
4.8
作者：
Gress, Kyle;Charipova, Karina;Urits, Ivan
通讯作者：
Urits, Ivan
影响因子：
2.3
作者：
Bonney, Phillip A.;Conner, Andrew K.;Sughrue, Michael E.
通讯作者：
Sughrue, Michael E.
影响因子：
6.6
作者：
GJERRIS, A;BECH, P;RAFAELSEN, OJ
通讯作者：
RAFAELSEN, OJ