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膝关节骨关节炎的磁共振治疗:一项随机、双盲、安慰剂对照试验。

Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

作者信息

Gökşen Nurgül, Çaliş Mustafa, Doğan Serap, Çaliş Havva T, Özgöçmen Salih

机构信息

Department of Physical Medicine and Rehabilitation, Erciyes University, Faculty of Medicine, Kayseri, Turkey -

出版信息

Eur J Phys Rehabil Med. 2016 Aug;52(4):431-9. Epub 2016 Jan 22.

Abstract

BACKGROUND

Therapeutic nuclear magnetic resonance therapy (MRT) works based on the electromagnetic fields.

AIM

To investigate efficacy of MRT in knee osteoarthritis (OA).

DESIGN

Prospective, randomized, double-blind, placebo controlled trial.

SETTING

Outpatient clinic, university hospital.

POPULATION

Patients who had mild to moderate knee OA at a single knee joint and between 30-75-years-old were randomized by blinded chip cards (1:1).

METHODS

The treatment group received ten sessions of one hour daily MRT, controls received placebo MRT. All patients underwent clinical examination at baseline, after 2 weeks, and 12 weeks. Imaging included blindly assessed ultrasonography and magnetic resonance (MR) of the knee.

RESULTS

Ninety-seven patients completed the study. Both groups improved significantly but the average change from baseline in outcome parameters was similar in MRT group (on VAS-pain,-2.6; WOMAC-pain, -2.09; WOMAC-stiffness, -1.81; WOMAC-physical, -1.96) compared to placebo after two weeks (VAS-pain,-1.6; WOMAC-pain, -1.91; WOMAC-stiffness, -1.27; WOMAC-physical, -1.54). Also changes were quite similar at the 12th week after the treatment. SF-36 components at 12th week improved but changes were not significant. Imaging arm also failed to show significant differences between groups in terms of cartilage thickness on US and MR scores. No adverse events were recorded.

CONCLUSIONS

MRT is safe, but not superior to placebo in terms of improvement in clinical or imaging parameters after a 10-day course of treatment in mild to moderate knee OA.

CLINICAL REHABILITATION IMPACT

The present study does not promote use of a 10-day course of MRT in mild to moderate knee OA.

摘要

背景

治疗性核磁共振疗法(MRT)基于电磁场发挥作用。

目的

探讨MRT治疗膝骨关节炎(OA)的疗效。

设计

前瞻性、随机、双盲、安慰剂对照试验。

地点

大学医院门诊。

研究对象

单膝关节患有轻至中度膝OA且年龄在30至75岁之间的患者,通过盲法芯片卡随机分组(1:1)。

方法

治疗组每天接受1小时的MRT治疗,共10次,对照组接受安慰剂MRT治疗。所有患者在基线、2周和12周时均接受临床检查。影像学检查包括对膝关节进行盲法评估的超声检查和磁共振成像(MR)。

结果

97名患者完成了研究。两组均有显著改善,但与安慰剂组相比,MRT组在治疗两周后(视觉模拟评分法[VAS]疼痛评分,-2.6;西安大略和麦克马斯特大学骨关节炎指数[WOMAC]疼痛评分,-2.09;WOMAC僵硬评分,-1.81;WOMAC身体功能评分,-1.96)以及治疗12周后,结局参数从基线的平均变化相似(VAS疼痛评分,-1.6;WOMAC疼痛评分,-1.91;WOMAC僵硬评分,-1.27;WOMAC身体功能评分,-1.54)。第12周时,SF-36各维度有所改善,但变化不显著。影像学检查结果在两组间的膝关节超声软骨厚度和MR评分方面也未显示出显著差异。未记录到不良事件。

结论

在轻至中度膝OA患者中,经过10天疗程的治疗后,MRT是安全的,但在临床或影像学参数改善方面并不优于安慰剂。

临床康复影响

本研究不支持在轻至中度膝OA中使用10天疗程的MRT。

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