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一项关于多发性硬化症痉挛患者干针治疗效果的研究:一项随机等待期对照试验方案。

A Study on the Effects of Dry Needling in Multiple Sclerosis Patients with Spasticity: Protocol of a Randomized Waitlist-Controlled Trial.

机构信息

Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.

Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Acupunct Meridian Stud. 2021 Apr 30;14(2):82-88. doi: 10.51507/j.jams.2021.14.2.82.

Abstract

BACKGROUND

Spasticity is a common symptom in multiple sclerosis (MS). Dry needling (DN) has been considered a useful method for the treatment of spasticity; however, there are no studies on the effects of DN on spasticity in patients with MS. We propose a study protocol aiming to investigate the effects of DN on spasticity in patients with MS.

METHODS

MS patients with plantar flexor spasticity will be recruited. Participants will be randomly assigned to the DN group, where they will be receiving a single session of DN, one minute for each head of gastrocnemius muscle, or to the waiting list control group with no intervention. Primary outcome measures are the Modified Ashworth Scale (MAS) for gastrocnemius spasticity, passive resistive torque, and podography for foot pressure distribution. The ankle active and passive range of dorsiflexion and Timed Up and Go tests are the secondary outcome measures. All outcomes will be measured at baseline, immediately after the intervention, and one week later. A mixed-model, general linear model, and two-way repeated-measures ANOVA will be used to compare the quantitative variables between groups and within groups at the measurement time points. The MAS ordinal measure of spasticity will be compared between groups using the Kruskal-Wallis test, and both the Friedman test and Wilcoxon test will be used for within-group changes.

DISCUSSION

This study will provide primary evidence on the effects of DN on gastrocnemius muscle spasticity and gait in patients with MS.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials (IRCT): IRCT20190617043918N1.

摘要

背景

痉挛是多发性硬化症(MS)的常见症状。干针疗法(DN)已被认为是治疗痉挛的一种有效方法;然而,目前尚无关于 DN 对 MS 患者痉挛影响的研究。我们提出了一项研究方案,旨在研究 DN 对 MS 患者痉挛的影响。

方法

将招募患有跖屈肌痉挛的 MS 患者。参与者将被随机分配到 DN 组,在该组中,他们将接受一次 DN 治疗,每头腓肠肌治疗一分钟,或分配到无干预的等待名单对照组。主要结局测量指标为改良 Ashworth 量表(MAS)评估的腓肠肌痉挛、被动阻力扭矩和足底压力分布的足印法。踝关节主动和被动背屈范围以及计时起立行走测试是次要结局测量指标。所有结局都将在基线、干预后立即和一周后进行测量。将使用混合模型、一般线性模型和双向重复测量方差分析来比较组间和组内的定量变量在测量时间点的差异。将使用 Kruskal-Wallis 检验比较 MAS 痉挛的等级测量值在组间的差异,同时使用 Friedman 检验和 Wilcoxon 检验比较组内的变化。

讨论

本研究将为 DN 对 MS 患者腓肠肌痉挛和步态的影响提供初步证据。

试验注册

伊朗临床试验注册中心(IRCT):IRCT20190617043918N1。

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