Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 11:53 AM
Study NCT ID:
NCT06649461
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-18
First Post:
2024-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Carpal Tunnel Syndrome Questionnaire', 'timeFrame': '10 minutes', 'description': 'As the score obtained from the survey increases, the improvement increases.'}, {'measure': 'visual analog scale', 'timeFrame': '1 minute', 'description': 'As the score approaches 10, the intensity of pain felt increases.'}, {'measure': 'electromyography (EMG)', 'timeFrame': '10 minutes', 'description': 'In the electrophysiological examination, median sensory nerve conduction studies and median motor nerve conduction studies will be measured. Median motor nerve latency, median motor nerve conduction velocity, and compound muscle action potential amplitude will be measured and recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['splint', 'ozone therapy', 'rehabilitation'], 'conditions': ['Carpal Tunnel Syndrome (CTS)']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months\n\nExclusion Criteria:\n\n* hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability)."}, 'identificationModule': {'nctId': 'NCT06649461', 'briefTitle': 'Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Splint with Ozone Injection for Mild and Moderate Carpal Tunnel: an Electrodiagnostic Study', 'orgStudyIdInfo': {'id': '2024/10.6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ozone injections', 'interventionNames': ['Procedure: ozone injections', 'Other: Splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'splint', 'interventionNames': ['Other: Splint']}], 'interventions': [{'name': 'ozone injections', 'type': 'PROCEDURE', 'description': 'Ozone injections (5 mL/10 μg/dL) were administered under aseptic conditions, with the wrist fixed in dorsiflexion, and with the insulin injector, a 23-gauge needle was inserted between the palmaris longus and flexor carpi radialis muscles at a 45-degree angle from the palmar distal line (Salutem/19147884379).', 'armGroupLabels': ['ozone injections']}, {'name': 'Splint', 'type': 'OTHER', 'description': 'hand splint for night', 'armGroupLabels': ['ozone injections', 'splint']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'Emine Cihan', 'investigatorAffiliation': 'Selcuk University'}}}}