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NCT Number: NCT06696651

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

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.

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Key information

Conditions

Electric Stimulation Fibromyalgia Muscular Diseases Musculoskeletal Diseases Myofascial Release Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

out-patient clinic, new Cairo hospital

Cairo, Egypt

Location contact

Maha Mostafa Osman, physical therapist

CONTACT

[email protected]

01112269937

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Electrical myostimulation

Device

Electrical myostimulation in form of suit as in fig. Blue lines demonstrate areas of electrodes inside suit. twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks . 20 min = 1 min warm up, 6min upper body training, 6min lower body training, 6min core training, 1 min cooling down.

Electronic cupping

Device

Twenty females will undergo two weekly myofascial release sessions and a healthy diet for six weeks, using electronic cupping to ensure equal pressure on tender points.

healthy diet

Other

The MedDiet diet focuses on high fat intake, primarily from extra-virgin olive oil, in vegetable dishes, and a high consumption of low-glycemic index carbohydrates like wholegrain cereals, legumes, nuts, fruits, and vegetables. Moderate to high fish consumption is also encouraged, with moderate to small amounts of poultry and dairy products. Red meat and meat products are limited or avoided.

Primary outcomes

  1. Assessment of change of body mass index

    Time frame: at baseline and after 6 weeks

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

  2. Assessment of change of pressure pain threshold using algometry

    Time frame: 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.

Secondary outcomes

  1. assessment of fibromyalgia using Fibromyalgia Impact Questionnaire

    Time frame: at baseline and after 6 weeks

    The FIQ-A measures physical function, work, and well-being, including pain, fatigue, stiffness, anxiety, and depression. The Arabic version has acceptable reliability and validity criteria, suitable for clinical practice and research in the Arabic speaking population.

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Mostafa Osman, physical therapist

CONTACT

[email protected]

01112269937

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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