Electric StimulationNCT06696651
Electrical Muscle Stimulation Effect Versus Myofascial Release on Quality of Life in Female Fibromyalgia
A study testing Electrical myostimulation, Electronic cupping and healthy diet in people with Electric Stimulation and Myofascial Release, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Electric Stimulation, Myofascial Release, Fibromyalgia
- What is being tested?
- Electrical myostimulation, Electronic cupping and healthy diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Peripheral vascular diseases.
- Drug abuse.
- Smokers.
- Chest disease. ( either obstructive or restrictive ).
- Clinical signs of sever cardiac events ( eg. Congestive heart disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
out-patient clinic, new Cairo hospital
Cairo
Maha Mostafa Osman, physical therapist, 01112269937, maha.m.azzam@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Electric Stimulation, Myofascial Release, Fibromyalgia
- Being tested
- Electrical myostimulation, Electronic cupping, healthy diet
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Myostimulation | Experimental | twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks . Receives: Device: Electrical myostimulation; Other: healthy diet |
| Myofascial Release | Active comparator | twenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks . Receives: Device: Electronic cupping; Other: healthy diet |
| Healthy diet | Active comparator | twenty females following healthy diet only for 6 weeks. Receives: Other: healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of body mass index
to measure body weight and height to calculate BMI for characterizing the sample.
Measured: 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.
Measured: 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.
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric StimulationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Osman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696651
- Sponsor's protocol ID
- Maha-004622
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Muscle Stimulation Effect Compared With Myofascial Release on Quality of Life in Female Fibromyalgia
- ClinicalTrials.gov ID
- NCT06696651
- Acronym / sponsor ID
- Maha-004622
- Conditions
- Electric Stimulation, Myofascial Release, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrical Myostimulation | Experimental | Device: Electrical myostimulation, Other: healthy diettwenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks . |
| Myofascial Release | Active comparator | Device: Electronic cupping, Other: healthy diettwenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks . |
| Healthy diet | Active comparator | Other: healthy diettwenty females following healthy diet only for 6 weeks. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Peripheral vascular diseases.
- Drug abuse.
- Smokers.
- Chest disease. ( either obstructive or restrictive ).
- Clinical signs of sever cardiac events ( eg. Congestive heart disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical myostimulationElectrical 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 | Electrical Myostimulation |
| Electronic cuppingTwenty 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. | Device | Myofascial Release |
| healthy dietThe 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. | Other | Electrical Myostimulation, Healthy diet, Myofascial Release |
Primary outcome
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.
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.
1 secondary outcome
assessment of fibromyalgia using Fibromyalgia Impact Questionnaire
Time frame: at baseline and after 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical myostimulation, Electronic cupping and healthy diet in people with Electric Stimulation and Myofascial Release, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Mostafa Osman, physical therapist (01112269937, maha.m.azzam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of body mass index (time frame: at baseline and after 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.