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临床试验/NCT06778681
NCT06778681已完成不适用

Is Cortical Motor Neuron Dysfunction the Underlying Mechanism of Fatigue in Fibromyalgia?

Istanbul Physical Medicine Rehabilitation Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
V-wave

研究概览

简要总结

The goal of this study is to test whether cortical motor neuron dysfunction plays a role in the pathogenesis of fatigue in fibromyalgia patients.

The main questions it aims to answer are:

Do fibromyalgia patients have lower v-wave compared to healthy subjects? Does cheering affect V-wave in fibromyalgia patients more than healthy subjects? Researchers will compare the V-waves of fibromyalgia patients with those of healthy subjects.

详细描述

All volunteers will first undergo the Fatigue Severity Scale (FSS) assessment, grip strength measurement, and a 4-meter walking speed test. Subsequently, V-wave recordings will be performed.

EMG and Force Data Acquisition

Surface EMG from the soleus muscle and force sensor data will be collected at a 2 kHz sampling rate using a data acquisition system (CED 3601 Power 1401 MKII digital-to-analogue converter and CED 1902 Quad System MKIII amplifier). Data analyses will be performed using Spike2 version 7.20 software.

Maximal plantar flexion will be performed against a force platform equipped with a force sensor (FC2231-0000-0100-L Compression Load Sensor, France) mounted on a wall and connected to a data acquisition device. Participants will be fixed to the examination table using a pelvic strap to prevent cranial movement during the contraction. This setup will allow real-time recording of muscle force during the 1-minute isometric contraction.

V-Wave Measurement Procedure

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Diagnosed with fibromyalgia according to acr 2016 criteria(for fibromyalgia group)
  • •Being healthy(for control group)
  • •18-60 years old
  • •Volunteering
  • •Being female
  • •Right hand dominant

排除标准

  • •Presence of scars, dermatitis, or similar conditions on the skin where surface EMG electrodes will be placed.
  • •Diseases causing muscle and nerve dysfunction: myopathies, polyneuropathy, radiculopathy, peripheral nerve lesions such as entrapment neuropathies; central nervous system disorders such as stroke, amyotrophic lateral sclerosis, multiple sclerosis, and parkinsonism.
  • •Hypertension and cardiac arrhythmias.
  • •Other diseases with fatigue symptoms: cardiopulmonary diseases, hypothyroidism, polymyalgia rheumatica, major depression, bipolar disorder, chronic fatigue syndrome.

研究组 & 干预措施

Fibromyalgia

Experimental

Subjects with diagnosed fibromyalgia will be in this arm. Subjects will have their grip strength and 4-meter walking speed measured and will be asked to fill the fatigue severity scale.

Subjects will be tested for v-wave during voluntary foot plantarflexion.

干预措施: Cheer (Other)

Healthy

Experimental

Healthy subjects will be in this arm. Subjects will have their grip strength and 4-meter walking speed measured and will be asked to score the fatigue severity scale.

Subjects will be tested for v-wave during voluntary foot plantarflexion.

干预措施: Cheer (Other)

结局指标

主要结局

V-wave

时间窗: On the day of testing

Subjects will be asked to perform voluntary foot plantar flexion. During 3rd, 20th, 40th, and 60th seconds v-wave will be measured. During the 60th second of voluntary foot plantar flexion subjects will be cheered to increase their flexion strength. V-wave/H-max ratio and V-wave amplitude changes during cheer will be compared between healthy and fibromyalgia subjects. A low ratio or amplitude will be interpreted in favor of fatigue.

次要结局

  • Grip strength(On the day of testing)
  • Fatigue severity scale(On the day of testing)
  • 4m walking speed(On the day of testing)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fuat Orhun Alayoglu

Resident Doctor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (2)

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