Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-11 @ 12:36 PM
Study NCT ID:
NCT07002892
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'İnvestigator, out comes assessor and participants will be blind to which procedure is performed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Our study was designed as a prospective, triple-blind, randomized study. Patients who applied to our hospital's PMR outpatient clinic and were diagnosed with moderate carpal tunnel syndrome by EMG will be included in the study."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2025-05-25', 'studyFirstSubmitQcDate': '2025-05-25', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale(VAS)', 'timeFrame': 'This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.', 'description': "Global pain:The VAS used for pain assessment consists of a line drawn in the form a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'' ) were asked to score."}], 'secondaryOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire', 'timeFrame': 'This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.', 'description': 'symptom severity and functional status scale'}, {'measure': 'Electromyography', 'timeFrame': 'This evaluation will be made and recorded at the beginning and at 24th weeks', 'description': 'Distal motor latency and sensory nerve conduction velocity'}, {'measure': 'Dynamometer', 'timeFrame': 'This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.', 'description': 'Hand grip strength measurement test'}, {'measure': 'Ultrasound', 'timeFrame': 'This evaluation will be made and recorded at the baseline, at the 4th, 12th and 24th weeks after the procedure.', 'description': 'Median nerve cross-sectional area measurement at the pisiform level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ozone therapy', 'corticosteroid injection', '%5 dextrose injection', 'median nerve', 'carpal tunnel syndrome'], 'conditions': ['Carpal Tunnel Syndrome Treatment']}, 'referencesModule': {'references': [{'pmid': '32732745', 'type': 'BACKGROUND', 'citation': 'Forogh B, Mohamadi H, Fadavi HR, Madani SP, Aflakian N, Ghazaie F, Babaei-Ghazani A. Comparison of Ultrasound-Guided Local Ozone (O2-O3) Injection Versus Corticosteroid Injection in Patients With Mild to Moderate Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2021 Feb 1;100(2):168-172. doi: 10.1097/PHM.0000000000001546.'}, {'pmid': '34213870', 'type': 'BACKGROUND', 'citation': 'Elawamy A, Hassanien M, Talaat EA, Ali AM, Roushdy ASI, Kamel EZ. Intra-Carpal Injection of Ozone versus Methylprednisolone in Carpal Tunnel Syndrome of Systemic Sclerosis Patients: A Randomized Single-Blind Clinical Trial. Pain Physician. 2021 Jul;24(4):E453-E458.'}, {'pmid': '31123423', 'type': 'BACKGROUND', 'citation': 'Bahrami MH, Raeissadat SA, Nezamabadi M, Hojjati F, Rahimi-Dehgolan S. Interesting effectiveness of ozone injection for carpal tunnel syndrome treatment: a randomized controlled trial. Orthop Res Rev. 2019 May 6;11:61-67. doi: 10.2147/ORR.S202780. eCollection 2019.'}, {'pmid': '35848821', 'type': 'BACKGROUND', 'citation': 'Babaei-Ghazani A, Moradnia S, Azar M, Forogh B, Ahadi T, Chaibakhsh S, Khodabandeh M, Eftekharsadat B. Ultrasound-guided 5% dextrose prolotherapy versus corticosteroid injection in carpal tunnel syndrome: a randomized, controlled clinical trial. Pain Manag. 2022 Sep;12(6):687-697. doi: 10.2217/pmt-2022-0018. Epub 2022 Jul 18.'}, {'pmid': '36617808', 'type': 'BACKGROUND', 'citation': 'Nasiri A, Rezaei Motlagh F, Vafaei MA. Efficacy comparison between ultrasound-guided injections of 5% dextrose with corticosteroids in carpal tunnel syndrome patients. Neurol Res. 2023 Jun;45(6):554-563. doi: 10.1080/01616412.2022.2164453. Epub 2023 Jan 8.'}, {'pmid': '30187524', 'type': 'BACKGROUND', 'citation': 'Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Effectiveness of corticosteroid and 5% dextrose versus USG-guided ozone injections in patients with carpal tunnel syndrome: Three blind randomized studies', 'detailedDescription': 'Patients who were diagnosed with moderate CTS by EMG after clinically diagnosing CTS in our hospital\'s PTR clinic will be included in our study. At the beginning of the study, based on the study conducted by Wu et al. (1) who evaluated the effectiveness of dextrose prolotherapy in the treatment of patients diagnosed with carpal tunnel syndrome, the minimum number of patients required for each group was determined as 20 with a mean pain VAS change of 20%, a significance level of 0.05 and a power analysis of 95%. Considering that there may be a 20% loss during the study, it was decided to include a total of 72 patients, at least 24 patients for each group.\n\nPatients who meet the inclusion criteria and fill out the "Informed Volunteer Consent Form" will be numbered according to their application order to the PTR clinic and will be randomized into three groups of 24 people using the "Research Randomizer" computer program, with the first group being the Ozone Group (OG), the second group being the Dextrose Group (DG) and the third group being the Corticosteroid Group (SG). Initial evaluations of the participants will be made before the injection. Each patient will receive one session of perineural injection of 1 ml betamethasone dipropionate mixed with 1 ml physiological serum to the first group; 2 ml 5% dextrose to the second group; and 2 ml 10 pg/ml ozone to the third group. The solutions to be administered will be prepared by one person in syringes that are taped shut from the outside, and then applied with a 27-gauge needle by a specialist physician who has no role in the evaluation of the results of the randomization section, from the proximal entrance of the carpal tunnel (scaphoid-psiform plane) under ultrasound guidance. In addition, each patient will wear a wrist splint for 8 hours daily during the post-treatment follow-up period. Treatment follow-up evaluations will be evaluated blindly by another specialist physician who has no role in the randomization, outcome evaluation and injection. Pre-treatment Visual Analog Scale (Global Pain), Boston Carpal Tunnel Questionnaire (Symptom Severity Scale and Functional Status Scale), Ultrasound (Measurement of median nerve cross-sectional area at pisiform level), EMG (Distal motor latency and sensory nerve conduction velocity), Hand grip strength measurement test (Dynamometer), VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 4th week, VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 12th week and VAS, Boston Carpal Tunnel Questionnaire, Ultrasound, Hand grip strength measurement test at the 24th week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-65 years old\n* Have been clinically diagnosed with carpal tunnel syndrome\n* Confirmation of moderate CTS diagnosis with EMG\n* Having typical CTS symptoms for at least 3 months\n* Not having benefited from splinting and rest\n\nExclusion Criteria:\n\n* History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome or wrist surgery\n* History of inflammatory arthritis, hypothyroidism, pregnancy, rheumatologic disorders or pacemaker\n* Current warfarin use, previous corticosteroid injection for CTS, trauma or neoplasm at the injection site, hypersensitivity to corticosteroids or skin infection(injection site)\n* G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability and those receiving ACE inhibitors'}, 'identificationModule': {'nctId': 'NCT07002892', 'briefTitle': 'Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Effectiveness of Corticosteroid and 5% Dextrose Versus USG-guided Ozone Injections in Patients With Carpal Tunnel Syndrome: Three Blind Randomized Studies', 'orgStudyIdInfo': {'id': '2024/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ozon treatment group', 'description': 'Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.', 'interventionNames': ['Drug: Ozon treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '%5 dextrose injection group', 'description': 'Each patient will receive 2 ml 5% dextrose perineural injection into the median nerve under US guidance, for 1 session.', 'interventionNames': ['Drug: Dextrose 5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'corticosteroid injection group', 'description': 'Each patient will receive 2 ml:(1 ml betamethasone dipropionate+1 ml saline) perineural injection into the median nerve under US guidance, for 1 session.', 'interventionNames': ['Drug: Steroid treatment']}], 'interventions': [{'name': 'Ozon treatment', 'type': 'DRUG', 'description': 'Each patient will receive 2 ml 10 μg/ml ozon perineural injection into the median nerve under US guidance, for 1 session.', 'armGroupLabels': ['ozon treatment group']}, {'name': 'Steroid treatment', 'type': 'DRUG', 'description': 'Each patient will receive 2 ml:(1 ml betamethasone dipropionate+1ml saline) perineural injection into the median nerve under US guidance, for 1 session.', 'armGroupLabels': ['corticosteroid injection group']}, {'name': 'Dextrose 5%', 'type': 'DRUG', 'otherNames': ['perineural dextrose injection'], 'description': 'Each patient will receive 2 ml %5 dextrose perineural injection into the median nerve under US guidance, for 1 session.', 'armGroupLabels': ['%5 dextrose injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'YUNUS BURAK BAYIR, SPECİALİST', 'role': 'CONTACT', 'email': 'yunusburakbayir@gmail.com', 'phone': '+905058083317'}, {'name': 'YUNUS BURAK BAYIR, SPECİALİST', 'role': 'CONTACT', 'email': 'yunusburakbayir@gmail.com', 'phone': '05058083317'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'YUNUS BURAK BAYIR, SPECİALİST', 'role': 'CONTACT', 'email': 'yunusburakbayir@gmail.com', 'phone': '+905058083317'}, {'name': 'AYŞEGÜL YAMAN, SPECİALİST', 'role': 'CONTACT', 'phone': '05052423917'}], 'overallOfficials': [{'name': 'BAŞAK MANSIZ KAPLAN, ASSOC. PROF.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara Etlik City Hospital'}, {'name': 'DAMLA CANKURTARAN, ASSOC. PROF.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara Etlik City Hospital'}, {'name': 'SELİN ÇELEBİER, ASSİSTANT DOCTOR', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yunus Burak Bayır', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Yunus Burak Bayır, Principal İnvestigator ,specialist doctor', 'investigatorFullName': 'Yunus Burak Bayır', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}