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

November 18, 2024 updated by: Maha Mostafa Osman, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • out-patient clinic, new Cairo hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline and after 6 weeks
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.
at baseline and after 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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