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脉冲电磁场治疗膝骨关节炎的多中心随机对照非劣效临床试验方案

Pulsed electromagnetic fields for the management of knee osteoarthritis: multicentre, randomised, controlled, non-inferiority trial protocol.

机构信息

Department of Rehabilitation Medicine Center, Sichuan University West China Hospital, Chengdu, Sichuan, China.

School of Rehabilitation Sciences, Sichuan University, Chengdu, Sichuan, China.

出版信息

BMJ Open. 2022 Sep 7;12(9):e060350. doi: 10.1136/bmjopen-2021-060350.


DOI:10.1136/bmjopen-2021-060350
PMID:36514244
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10441616/
Abstract

INTRODUCTION: Pulsed electromagnetic field (PEMF) is an available treatment for knee osteoarthritis (KOA), which is the most common cause of pain and disability. Nonetheless, whether the clinical effects are like that of most used drugs is unclear. Thus, this study aims to determine the effect of PEMF on pain relief by comparing them with the positive drug (celecoxib). Furthermore, this clinical trial aims to evaluate the effect of PEMF on function and quality of life with a long-term follow-up. METHODS AND ANALYSIS: This two-armed, non-inferiority, randomised, controlled trial will be conducted in the outpatient physiatry/physiotherapy clinic or inpatient ward of 17 hospitals in China. A total of 428 individuals will be included who are more than 40 years of age with diagnosed KOA. The participants will be randomly allocated to the PEMF group: receiving a 6-week PEMF (15 Hz, 30 mT) at a frequency of 40 min per day, 5 days per week plus sham drug (n=214), or drug group: receiving a 6-week celecoxib 200 mg combined with sham PEMF (n=214). Clinical outcomes will be measured at baseline (T0), mid-term of intervention (T1), post-intervention (T2), 10, 18 and 30 weeks (T3-5) of follow-up after randomisation. The primary outcome will be the Western Ontario and McMaster Universities (WOMAC) pain index. The secondary outcomes will be WOMAC function and stiffness, pain measured by numerical rating score, quality of life, 6-minute walk test, pain catastrophising scale and responder index. ETHICS AND DISSEMINATION: The trial is performed following the Declaration of Helsinki. The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2021-220). All patients will give informed consent before participation and the trial is initiated after approval. Results of this trial will be disseminated through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2100052131.

摘要

简介:脉冲电磁场(PEMF)是治疗膝骨关节炎(KOA)的一种有效方法,KOA 是疼痛和残疾的最常见原因。然而,其临床效果是否与大多数常用药物一样尚不清楚。因此,本研究旨在通过与阳性药物(塞来昔布)进行比较,确定 PEMF 缓解疼痛的效果。此外,这项临床试验旨在通过长期随访评估 PEMF 对功能和生活质量的影响。

方法和分析:这是一项双臂、非劣效性、随机、对照试验,将在中国 17 家医院的门诊物理治疗/物理疗法诊所或住院病房进行。共有 428 名年龄在 40 岁以上、确诊为 KOA 的患者将被纳入研究。参与者将被随机分配到 PEMF 组:接受为期 6 周的 PEMF(15 Hz,30 mT)治疗,每天 40 分钟,每周 5 天,同时接受假药物治疗(n=214),或药物组:接受为期 6 周的塞来昔布 200 mg 联合假 PEMF 治疗(n=214)。临床结局将在基线(T0)、干预中期(T1)、干预后(T2)、随机分组后 10、18 和 30 周(T3-5)进行测量。主要结局将是西部安大略省和麦克马斯特大学(WOMAC)疼痛指数。次要结局将是 WOMAC 功能和僵硬、数字评分法测量的疼痛、生活质量、6 分钟步行试验、疼痛灾难化量表和应答者指数。

伦理和传播:该试验遵循《赫尔辛基宣言》进行。研究方案和知情同意书已获得四川大学华西医院生物医学研究伦理委员会的批准(编号:#2021-220)。所有患者在参与前均会给予知情同意,并且在获得批准后才开始试验。该试验的结果将通过发表在同行评议的期刊上进行传播。

试验注册号:ChiCTR2100052131。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0232/10441616/a0fe238496da/bmjopen-2021-060350f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0232/10441616/49964dd05b8a/bmjopen-2021-060350f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0232/10441616/a0fe238496da/bmjopen-2021-060350f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0232/10441616/49964dd05b8a/bmjopen-2021-060350f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0232/10441616/a0fe238496da/bmjopen-2021-060350f02.jpg

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引用本文的文献

[1]
Current Evidence Using Pulsed Electromagnetic Fields in Osteoarthritis: A Systematic Review.

J Clin Med. 2024-3-28

本文引用的文献

[1]
Burden of osteoarthritis in China, 1990-2017: findings from the Global Burden of Disease Study 2017.

Lancet Rheumatol. 2020-3

[2]
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J Med Ultrasound. 2021-3-20

[3]
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Lancet. 2021-12-19

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Ann Rheum Dis. 2020-5-12

[6]
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Phys Ther. 2020-7-19

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PLoS One. 2019-12-3

[9]
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