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Not yet recruiting NCT06696651

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

No phase Interventional Electric Stimulation Myofascial Release Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical myostimulation, Electronic cupping, healthy diet.
Who it may be relevant to
Registry conditions: Electric Stimulation, Myofascial Release, Fibromyalgia. Basic parameters: 45 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device Electrical myostimulation
    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.
  • Device Electronic cupping
    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.
  • Other healthy diet
    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 outcome measures

  • Assessment of change of body mass index [Time frame: at baseline and after 6 weeks]
  • Assessment of change of pressure pain threshold using algometry [Time frame: at baseline and after 6 weeks]
Secondary outcome measures (1)
  • assessment of fibromyalgia using Fibromyalgia Impact Questionnaire [Time frame: at baseline and after 6 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • out-patient clinic, new Cairo hospital — Cairo

Identifiers

NCT: NCT06696651 · Maha-004622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗