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中药外治法联合脉冲电磁场对老年膝骨关节炎患者的影响:一项随机对照试验的研究方案

Effects of external Chinese herbal therapy combined with pulse electromagnetic field on older adults with knee osteoarthritis: study protocol for a randomized controlled trial.

作者信息

Li Xiang, Li Foxiao, Yu An, Bu Qi, Wang Ruirui, Li Lijing, Zhang Wei, Yang Lei

机构信息

Department of Rehabilitation Medicine, The Second People's Hospital of Kunming, Kunming, Yunnan, China.

Department of Rehabilitation Medicine, Yan'an Hospital of Kunming City, Kunming, Yunnan, China.

出版信息

Front Med (Lausanne). 2025 May 22;12:1498622. doi: 10.3389/fmed.2025.1498622. eCollection 2025.

Abstract

INTRODUCTION

Knee osteoarthritis (KOA) is a major cause of disability, and both external Chinese herbal therapy (ECHT) and pulsed electromagnetic field (PEMF) therapy have shown potential in managing KOA symptoms. However, no research has directly compared the efficacy of ECHT, PEMF, and their combined use on pain relief and functional improvement in older adults with KOA. This highlights a significant research opportunity to explore the comparative benefits of these treatment modalities.

METHODS AND ANALYSIS

This randomized controlled trial (RCT) aims to enroll 124 older adults with KOA and will randomly allocate them across four treatment groups: (1) exercise with health education, (2) exercise with ECHT, (3) exercise with PEMF therapy, and (4) exercise with a combination of ECHT and PEMF. Each intervention will be administered five times per week for 4 weeks. The primary endpoints are pain and functional capacity, while secondary measures encompass lower limb range of motion, alignment, joint space, and serum cytokine levels. Assessments will be conducted at baseline, post-intervention, and at the 4-week follow-up.

DISCUSSION

This trial is poised to conduct a thorough comparative analysis of the impacts of ECHT, PEMF therapy, and their combined application in older adults with KOA. The study findings will not only inform clinical practice by offering data-driven recommendations but also enrich the scientific discourse on the complex interplay between inflammation, pain, and function in KOA.

CLINICAL TRIAL REGISTRATION

Chinese clinical trial registry platform: www.chictr.org.cn (no. ChiCTR2400087644).

摘要

引言

膝关节骨关节炎(KOA)是导致残疾的主要原因,外用中药疗法(ECHT)和脉冲电磁场(PEMF)疗法在缓解KOA症状方面均显示出潜力。然而,尚无研究直接比较ECHT、PEMF及其联合使用对老年KOA患者疼痛缓解和功能改善的疗效。这凸显了探索这些治疗方式比较优势的重大研究机会。

方法与分析

这项随机对照试验(RCT)旨在招募124名老年KOA患者,并将他们随机分配到四个治疗组:(1)健康教育结合运动,(2)ECHT结合运动,(3)PEMF疗法结合运动,(4)ECHT与PEMF联合结合运动。每种干预措施每周进行5次,共4周。主要终点是疼痛和功能能力,次要指标包括下肢活动范围、对线、关节间隙和血清细胞因子水平。将在基线、干预后和4周随访时进行评估。

讨论

本试验准备对ECHT、PEMF疗法及其联合应用对老年KOA患者的影响进行全面的比较分析。研究结果不仅将通过提供数据驱动的建议为临床实践提供信息,还将丰富关于KOA炎症、疼痛和功能之间复杂相互作用的科学论述。

临床试验注册

中国临床试验注册平台:www.chictr.org.cn(注册号:ChiCTR2400087644)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b7/12137307/ad191567543b/fmed-12-1498622-g001.jpg

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