Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 4:47 AM
Study NCT ID:
NCT05387135
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2022-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': '3 months', 'description': 'to describe pain on 0 to 10 scale'}], 'secondaryOutcomes': [{'measure': 'Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '3 months', 'description': 'for function and activity assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vagus nerve stimulation, knee osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '39828740', 'type': 'DERIVED', 'citation': 'Elsehrawy GG, Ibrahim ME, A Moneim NH, Hefny MA, El Shaarawy NK. Transcutaneous vagus nerve stimulation as a pain modulator in knee osteoarthritis: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2025 Jan 20;26(1):68. doi: 10.1186/s12891-025-08288-6.'}]}, 'descriptionModule': {'briefSummary': 'a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). The electrode was placed in the left cymba concha with direct contact on the skin. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 25 Hz. All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions.', 'detailedDescription': 'The included study population is 68.\n\n* Group (1): (tVNS group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to tVNS.\n* Group (2): (sham group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to sham treatment.\n\nDESCRIPTION OF THE TECHNIQUE\n\nActive treatment:\n\nAfferents of the Auricular branch of vagus nerve were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz.\n\nSham procedure:\n\nFor sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.\n\nAll participants initially will be evaluated before and after intervention and 3 months after the end of the sessions by the following:\n\nOUTCOME MEASURES AND ASSESSMENT QUESTIONNAIRES\n\n1. Visual analogue scale (VAS)\n2. PainDETECT questionnaire\n3. DN4 questionnaire\n4. Radiological Imaging\n5. Knee injury and Osteoarthritis Outcome Score\n6. Hospital Anxiety Depression Scale\n7. Physical Function Tests\n8. Quantitative sensory testing\n9. The Central Sensitization Inventory'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders.\n* Adult over 18 years.\n* People who were diagnosed.\n* Reported pain on visual analogue scale (VAS)\\>4/10.\n* Able to understand the informed consent.\n\nExclusion Criteria:\n\n* Peptic ulcer\n* Pace maker\n* Asthma or severe chronic obstructive pulmonary disease\n* Pregnancy.\n* Cellulites, skin ulceration at area of therapy application.\n* Inability to fulfill follow-up criteria.'}, 'identificationModule': {'nctId': 'NCT05387135', 'briefTitle': 'Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '3905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham Transcutaneous Vagus Nerve Stimulation', 'description': 'For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transcutaneous Vagus Nerve Stimulation', 'description': 'Afferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM) made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz.', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation']}], 'interventions': [{'name': 'Transcutaneous Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': 'Afferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000).', 'armGroupLabels': ['Transcutaneous Vagus Nerve Stimulation', 'sham Transcutaneous Vagus Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'Mohammed A Hefny, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor of physical medicine, rheumatology and rehabilitation'}, {'name': 'Nashwa K Elshaarawy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assisstant professor of physical medicine, rheumatology and rehabilitation'}, {'name': 'Nermeen H Abdelmoneam, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer of physical medicine, rheumatology and rehabilitation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Gehad Gamal Elsehrawy', 'investigatorAffiliation': 'Suez Canal University'}}}}