Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 3:31 AM
Study NCT ID:
NCT06237634
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroid And Ozone Injection In Patıents With 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'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D010126', 'term': 'Ozone'}], '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'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Carpal Tunnel Syndrome Questionnaire', 'timeFrame': 'at baseline, week 6, week 12', 'description': 'The BCTQ comprises two subscales. The Symptom Severity Scale yields PRO data on the level of symptoms, while the Functional Status Scale assesses the level of hand function. The Symptom Severity Scale consists of 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms, and difficulty of grasping. The Functional Status Scale contains eight items, which assess functional deficits in the following domains: writing, buttoning clothes, holding a book while reading, gripping a telephone handle, opening jars, performing household chores, carrying grocery bags, bathing and dressing. Each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function. A Finnish version of the BCTQ, which was used in this study, has been previously validated'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'at baseline, week 6, week 12', 'description': 'Visual analog scale A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.\n\nUsing a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}, {'measure': 'ultrasound measurements', 'timeFrame': 'at baseline, week 6, week 12', 'description': 'median nerve diameter measurement'}, {'measure': 'EMG measurements', 'timeFrame': 'at baseline, week 6, week 12', 'description': 'median nerve latancy,amplitud, velocity measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ozone injection', 'corticosteroid injection', 'carpal tunnel sendromu', 'ultrasound guided injection'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients..\n\n106 patients included in the study were randomized and divided into three groups. During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.', 'detailedDescription': '106 patients included in the study were randomized and divided into three groups.\n\nDuring the follow-up, a total of 90 patients, 30 patients in each group, completed the study.\n\nNeutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group.\n\nIn addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under USG guidance to 30 patients included in the corticosteroid group.\n\nIn addition to splint and exercise therapy, 3 cc ozone (O2-O3), 10 micrograms were injected under USG guidance to 30 patients in the ozone group.\n\nPatients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment.\n\nEvaluation methods include provocative tests (Tinnel, Phallen, Flick tests), visual analogue scale (VAS) numbness day/night and VAS pain scores, sensory tests (two-point discrimination and Semmes Weinstein monofilament test (SWMT)), hand and finger grip strengths. measurement, Boston carpal tunnel syndrome questionnaire (BCTA), median nerve cross-sectional area (MSCA) measurement with USG and electrophysiological parameters were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-70, male or female.\n* Clinically and electrophysiologically diagnosed with mild or moderate CTS\n* Having symptoms for 1 month or longer\n* No contraindications for corticosteroid and ozone application\n* Patients whose consent was obtained to participate in the study\n\nExclusion Criteria:\n\n* Under 18 years old and over 70 years old\n* Having a severe CTS\n* Having thenar atrophy\n* Those with diabetes, thyroid and kidney disease and CTS developing secondary to this\n* Those with previous traumatic nerve injury, peripheral nerve injury or surgery\n* Those with a diagnosis of polyneuropathy\n* Having rheumatic disease\n* With known radiculopathy\n* are pregnant\n* Known G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability\n* Those who have infection, burns, cuts or skin integrity in the skin area to be treated\n* Cognitive disorder, severe psychiatric illness\n* Those with diabetes, thyroid and kidney disease and CTS developing secondary to this\n* Patients who have not received corticosteroid or ozone injection in the last 3 months'}, 'identificationModule': {'nctId': 'NCT06237634', 'briefTitle': 'Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'Kayseri CH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'First group (30 people): A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side..', 'interventionNames': ['Other: splint and exercise and advices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'corticosteroid group', 'description': 'Second group (30 people): In addition to the treatment and recommendations given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected into the wrist under ultrasound guidance.', 'interventionNames': ['Other: splint and exercise and advices', 'Other: Triamsinolon Asetonid ozone']}, {'type': 'EXPERIMENTAL', 'label': 'ozone group', 'description': 'Third group (30 people): In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.', 'interventionNames': ['Other: splint and exercise and advices', 'Other: ozone']}], 'interventions': [{'name': 'splint and exercise and advices', 'type': 'OTHER', 'description': 'A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.', 'armGroupLabels': ['control group', 'corticosteroid group', 'ozone group']}, {'name': 'Triamsinolon Asetonid ozone', 'type': 'OTHER', 'description': "40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance.", 'armGroupLabels': ['corticosteroid group']}, {'name': 'ozone', 'type': 'OTHER', 'description': 'In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.', 'armGroupLabels': ['ozone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'health sciences university Kayseri medicine faculty', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': '38080', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'HAVVA TALAY CALIS, PROF. DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Havva Talay Calıs', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}