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基于功能近红外光谱技术(fNIRS)评估物理治疗对膝骨关节炎疼痛和功能障碍的效果:一项随机对照试验方案。

Evaluation of the effect of physical therapy on pain and dysfunction of knee osteoarthritis based on fNIRS: a randomized controlled trial protocol.

机构信息

Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, People's Republic of China.

Key Laboratory of Rehabilitation Medicine, West China Hospital, Sichuan University, 610041, Chengdu, People's Republic of China.

出版信息

BMC Musculoskelet Disord. 2023 Feb 28;24(1):152. doi: 10.1186/s12891-022-06074-2.

Abstract

BACKGROUND

Knee osteoarthritis (KOA) is a chronic musculoskeletal disease that can cause joint pain and dysfunction, affecting the quality of life of patients. Nonsurgical treatment is the conventional treatment of KOA, among which physical therapy is widely used because of its simplicity, convenience and effectiveness. The functional biomarker will add to the clinical fidelity and diagnostic accuracy. Therefore, our study chose a more objective evaluation indicator, functional near-infrared spectroscopy (fNIRS), to identify between healthy people and KOA patients, and to detect the pain change before and after treatment of KOA patients.

METHODS

The study will be conducted in the Rehabilitation Medical Center of West China Hospital of Sichuan University and divided into 2 stages. In the first stage, we will compare and determine the differences in baseline data between healthy volunteers and KOA patients. In the second stage, 72 KOA patients will be randomly divided into two groups: the drug therapy group (DT) and the combination therapy group (CT) for 10 treatments. Outcome measures will be measured at baseline and on the 5th and 10th days after the intervention, including the numerical rating scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain catastrophizing scale (PCS), the association of pain severity with task-state functional connectivity fNIRS and association of pain severity with task-activated fNIRS.

DISCUSSION

By analyzing the fNIRS data of healthy volunteers and KOA patients, our study will be determined whether fNIRS can be used as a new indicator to reflect the severity of pain in KOA patients. Subsequently, the same fNIRS data for KOA patients before and after the intervention will be collected to provide an accurate evaluation criterion for the effect of physical therapy on KOA.

TRIAL REGISTRATION

The study was registered on the Chinese Registry website (registered in ChiCTR.org with the identifiers ChiCTR2200064175 and 29/09/2022).

摘要

背景

膝骨关节炎(KOA)是一种慢性肌肉骨骼疾病,可导致关节疼痛和功能障碍,影响患者的生活质量。非手术治疗是 KOA 的常规治疗方法,其中物理治疗因其简单、方便和有效而被广泛应用。功能生物标志物将增加临床真实性和诊断准确性。因此,我们的研究选择了一种更客观的评估指标,即功能性近红外光谱(fNIRS),以识别健康人和 KOA 患者之间的差异,并检测 KOA 患者治疗前后的疼痛变化。

方法

该研究将在四川大学华西医院康复医学中心进行,分为两个阶段。第一阶段,我们将比较并确定健康志愿者和 KOA 患者之间的基线数据差异。第二阶段,将 72 例 KOA 患者随机分为药物治疗组(DT)和联合治疗组(CT),共进行 10 次治疗。在干预前、第 5 天和第 10 天测量结局指标,包括数字评分量表(NRS)、西部安大略省和麦克马斯特大学骨关节炎指数(WOMAC)、疼痛灾难化量表(PCS)、疼痛严重程度与任务状态功能连接 fNIRS 的关联以及疼痛严重程度与任务激活 fNIRS 的关联。

讨论

通过分析健康志愿者和 KOA 患者的 fNIRS 数据,我们的研究将确定 fNIRS 是否可以作为反映 KOA 患者疼痛严重程度的新指标。随后,将收集 KOA 患者干预前后相同的 fNIRS 数据,为物理治疗对 KOA 的疗效提供准确的评价标准。

试验注册

该研究在中国临床试验注册中心网站上注册(在中国临床试验注册中心注册,注册号 ChiCTR2200064175,注册日期 2022 年 9 月 29 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13b6/9972641/f75712745259/12891_2022_6074_Fig1_HTML.jpg

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