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Not yet recruitingNCT06696651Updated Nov 20, 2024

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

An interventional study of Electrical myostimulation and Electronic cupping in Electric Stimulation, Myofascial Release and Fibromyalgia, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Electric Stimulation
  • Myofascial Release
  • Fibromyalgia

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03

In context

Fibromyalgia

1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Peripheral vascular diseases.
  2. Drug abuse.
  3. Smokers.
  4. Chest disease. ( either obstructive or restrictive ).
  5. Clinical signs of sever cardiac events ( eg. Congestive heart disease).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Electrical Myostimulation

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

    Device: Electrical myostimulation · Other: healthy diet

  • Active comparator
    Myofascial Release

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

    Device: Electronic cupping · Other: healthy diet

  • Active comparator
    Healthy diet

    twenty females following healthy diet only for 6 weeks.

    Other: healthy diet

Interventions

  • DeviceElectrical 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.

  • DeviceElectronic 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.

  • Otherhealthy 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.

06

What researchers measure

Primary outcomes

  1. Assessment of change of body mass index

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

    Time frame: at baseline and after 6 weeks

  2. Assessment of change of pressure pain threshold using algometry

    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.

    Time frame: at baseline and after 6 weeks

Secondary outcomes

  1. assessment of fibromyalgia using Fibromyalgia Impact Questionnaire

    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.

    Time frame: at baseline and after 6 weeks

07

Study locations

1 site
  • out-patient clinic, new Cairo hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06696651
Lead sponsor
Cairo University
Responsible party
Maha Mostafa Osman (principal investigator, Cairo University) — Principal investigator
First posted
Nov 20, 2024
Start date
Dec 15, 2024 (estimated)
Primary completion
Feb 15, 2025 (estimated)
Completion
Mar 15, 2025 (estimated)
Last update
Nov 20, 2024

Study contacts

Maha Mostafa Osman, physical therapist
Contact
maha.m.azzam@gmail.com
01112269937

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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