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

Electrical Muscle Stimulation Effect Compared With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia; Electric Stimulation; Myofascial Release
• Intervention / Treatment: Device: Electrical myostimulation; Other: healthy diet; Device: Electronic cupping

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa Osman, physical therapist; Phone Number: 01112269937; Email: maha.m.azzam@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • out-patient clinic, new Cairo hospital
    • Contact: Maha Mostafa Osman, physical therapist; Phone Number: 01112269937; Email: maha.m.azzam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical Myostimulation; twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks .	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.; 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.
Active Comparator: Myofascial Release; twenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks .	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.; 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.
Active Comparator: Healthy diet; twenty females following healthy diet only for 6 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline and after 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Maha-004622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No