Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 4:31 AM
Study NCT ID:
NCT06539793
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
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': 'D015444', 'term': 'Exercise'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Numeric Pain Rating Scale', 'timeFrame': '4 weeks', 'description': 'Assessment of pain intensity (0-no pain, 10-most intense pain)'}, {'measure': 'Biochemical analysis', 'timeFrame': '4 weeks', 'description': 'Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment.'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '4 weeks', 'description': 'Assess functional outcome'}, {'measure': 'Pressure Pain Thresholds', 'timeFrame': '4 weeks', 'description': 'Assess pain sensitivity through pressure algometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'NEUROMODULATION', 'Centralization', 'PAIN BIOMARKERS', 'FUNCTIONAL OUTCOME'], 'conditions': ['Fibromyalgia Syndrome']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.', 'detailedDescription': 'Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.\n\nGroup B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients fibromyalgia from both genders.\n2. The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.\n3. Their ages will be ranged from 25-35 years old.\n4. They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) \\>26.\n\nExclusion Criteria:\n\n1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease\n2. Pacemaker\n3. Spinal fusion-cervical or lumbar\n4. Metal implants in the spine\n5. Pregnancy\n6. Epilepsy\n7. Severe psychiatric disorder or alcohol and drug abuse.\n8. Unstable medical condition which could compromise the participant's welfare or confound the study results.\n9. Uncontrolled blood pressure or diabetes\n10. Visual or auditory problems.\n11. Active inflammatory conditions"}, 'identificationModule': {'nctId': 'NCT06539793', 'briefTitle': 'Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'AlRyada University for Science & Technology'}, 'officialTitle': 'Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group (A)', 'description': 'Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.', 'interventionNames': ['Other: Aerobic Exercises', 'Other: Transcutaneous electrical nerve stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Control group (B)', 'description': 'Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.', 'interventionNames': ['Other: Aerobic Exercises']}], 'interventions': [{'name': 'Aerobic Exercises', 'type': 'OTHER', 'description': 'Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool.', 'armGroupLabels': ['Control group (B)', 'Study group (A)']}, {'name': 'Transcutaneous electrical nerve stimulation', 'type': 'OTHER', 'description': 'will be applied for all patients, which uses an asymmetrical biphasic alternating current in the continuous mode (pulse duration 100 µs, low frequency). TENS intensity will increase slowly, and patients will be instructed to indicate sensory threshold (ST); then, the intensity are going to increase until the sensation perceived as "strong but comfortable" (SC1). The duration will be for 30 minutes, 3times/ week for 4 weeks', 'armGroupLabels': ['Study group (A)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sadat', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Alshimy, PHD', 'role': 'CONTACT', 'email': 'ahmed.alshimy@rst.edu.eg', 'phone': '0201115116030'}], 'facility': 'Al Ryada University for Science and Technology', 'geoPoint': {'lat': 31.22371, 'lon': 34.20837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Alshimy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Lecturer and Consultant in Physical Therapy at Department of Neurology and it's Surgery. Faculty of Physical Therapy Al Ryada University for Science and Technology, Egypt", 'investigatorFullName': 'Ahmed Alshimy', 'investigatorAffiliation': 'AlRyada University for Science & Technology'}}}}