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临床试验/NCT06696651
NCT06696651尚未招募不适用

Electrical Muscle Stimulation Effect Compared With Myofascial Release on Quality of Life in Female Fibromyalgia

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Assessment of change of body mass index

研究概览

简要总结

the study was done to investigate the effect of Electrical Muscle Stimulation as muscle strengthening versus the effect of myofascial releasing on quality of life in female fibromyalgia patients while following Mediterranean diet.

详细描述

Fibromyalgia is a chronic pain condition characterized by unrefreshing sleep, physical exhaustion, and cognitive difficulties. It affects all populations worldwide and requires a diagnosis of widespread pain for at least three months. People with Fibromyalgia show abnormal endogenous pain modulation, including reduced conditioned pain modulation and exercise-induced hypoalgesia. Exercise is considered a first-line treatment for Fibromyalgia. Electrical myostimulation has been shown to improve pain, sleep subscales, and quality of life. A potential causal link between Fibromyalgia and micronutrient deficiency has been suggested. The study focuses on fibromyalgia, which affects mostly females and is difficult to diagnose easily. Electrical myostimulation and myofascial release are effective treatments for Fibromyalgia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Sixty females have diagnosed suffering from fibromyalgia syndrome.
  • •Their ages will be ranged from 45 to 55 years old.
  • •Their body mass index will be ranged from 25 to 34 ( overweight and obese type 1)
  • •They have willingness to participate in this study.

排除标准

  • •Peripheral vascular diseases.
  • •Drug abuse.
  • •Chest disease. ( either obstructive or restrictive ).
  • •Clinical signs of sever cardiac events ( eg. Congestive heart disease).

研究组 & 干预措施

Electrical Myostimulation

Experimental

twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks .

干预措施: Electrical myostimulation (Device)

Electrical Myostimulation

Experimental

twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks .

干预措施: healthy diet (Other)

Myofascial Release

Active Comparator

twenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks .

干预措施: Electronic cupping (Device)

Myofascial Release

Active Comparator

twenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks .

干预措施: healthy diet (Other)

Healthy diet

Active Comparator

twenty females following healthy diet only for 6 weeks.

干预措施: healthy diet (Other)

结局指标

主要结局

Assessment of change of body mass index

时间窗: at baseline and after 6 weeks

to measure body weight and height to calculate BMI for characterizing the sample.

Assessment of change of pressure pain threshold using algometry

时间窗: at baseline and after 6 weeks

Algometry is a useful tool for assessing central allodynia and hyperalgesia in FM and other pain conditions. It can provide insights into psychological factors influencing pain experience, new dynamic pain indicators, and neuroimaging techniques.

次要结局

  • assessment of fibromyalgia using Fibromyalgia Impact Questionnaire(at baseline and after 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Mostafa Osman

principal investigator

Cairo University

研究点 (1)

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