NCT06696651

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 18, 2024

Last Update Submit

November 18, 2024

Conditions

Electric StimulationMyofascial ReleaseFibromyalgia

Outcome Measures

Primary Outcomes (2)

  • Assessment of change of body mass index

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

    at baseline and after 6 weeks

  • 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.

    at baseline and after 6 weeks

Secondary Outcomes (1)

  • assessment of fibromyalgia using Fibromyalgia Impact Questionnaire

    at baseline and after 6 weeks

Study Arms (3)

Electrical Myostimulation

EXPERIMENTAL

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

Device: Electrical myostimulationOther: healthy diet

Myofascial Release

ACTIVE COMPARATOR

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

Device: Electronic cuppingOther: healthy diet

Healthy diet

ACTIVE COMPARATOR

twenty females following healthy diet only for 6 weeks.

Other: healthy diet

Interventions

Electrical myostimulationDEVICE

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.

Electrical Myostimulation
Electronic cuppingDEVICE

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.

Myofascial Release
healthy dietOTHER

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.

Electrical MyostimulationHealthy dietMyofascial Release

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details1. Sixty females have diagnosed suffering from fibromyalgia syndrome. 2. Their ages will be ranged from 45 to 55 years old.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, new Cairo hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Maha Mostafa Osman, physical therapist

CONTACT

01112269937maha.m.azzam@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

December 15, 2024

Primary Completion

February 15, 2025

Study Completion

March 15, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)