Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 6:02 AM
Study NCT ID:
NCT06696651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Muscle Stimulation Effect Versus Myofascial Release on Quality of Life in Female Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072001', 'term': 'Diet, Healthy'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of change of body mass index', 'timeFrame': 'at baseline and after 6 weeks', 'description': 'to measure body weight and height to calculate BMI for characterizing the sample.'}, {'measure': 'Assessment of change of pressure pain threshold using algometry', 'timeFrame': 'at baseline and after 6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'assessment of fibromyalgia using Fibromyalgia Impact Questionnaire', 'timeFrame': 'at baseline and after 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electric Stimulation', 'Myofascial Release', 'Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': '1. Sixty females have diagnosed suffering from fibromyalgia syndrome.\n2. Their ages will be ranged from 45 to 55 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sixty females have diagnosed suffering from fibromyalgia syndrome.\n2. Their ages will be ranged from 45 to 55 years old.\n3. Their body mass index will be ranged from 25 to 34 ( overweight and obese type 1)\n4. They have willingness to participate in this study.\n\nExclusion Criteria:\n\n1. Peripheral vascular diseases.\n2. Drug abuse.\n3. Smokers.\n4. Chest disease. ( either obstructive or restrictive ).\n5. Clinical signs of sever cardiac events ( eg. Congestive heart disease).'}, 'identificationModule': {'nctId': 'NCT06696651', 'briefTitle': 'Electrical Muscle Stimulation Effect Versus Myofascial Release on Quality of Life in Female Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Electrical Muscle Stimulation Effect Compared With Myofascial Release on Quality of Life in Female Fibromyalgia', 'orgStudyIdInfo': {'id': 'Maha-004622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical Myostimulation', 'description': 'twenty females will receive EMS session per week ( 20mins / week ) and following healthy diet for 6 weeks .', 'interventionNames': ['Device: Electrical myostimulation', 'Other: healthy diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Myofascial Release', 'description': 'twenty female will receive myofascial release sessions ( 2 sessions / week) and following healthy diet for 6 weeks .', 'interventionNames': ['Device: Electronic cupping', 'Other: healthy diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy diet', 'description': 'twenty females following healthy diet only for 6 weeks.', 'interventionNames': ['Other: healthy diet']}], 'interventions': [{'name': 'Electrical myostimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Electrical Myostimulation']}, {'name': 'Electronic cupping', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Myofascial Release']}, {'name': 'healthy diet', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Electrical Myostimulation', 'Healthy diet', 'Myofascial Release']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Maha Mostafa Osman, physical therapist', 'role': 'CONTACT', 'email': 'maha.m.azzam@gmail.com', 'phone': '01112269937'}], 'facility': 'out-patient clinic, new Cairo hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maha Mostafa Osman, physical therapist', 'role': 'CONTACT', 'email': 'maha.m.azzam@gmail.com', 'phone': '01112269937'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maha Mostafa Osman', 'investigatorAffiliation': 'Cairo University'}}}}