Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-29 @ 1:21 PM
Study NCT ID:
NCT07167667
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Median Nerve Thickness of the Carpal Tunnel Syndrome After Two Different Physiotherapy Modalities
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': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Nerve Thickness', 'timeFrame': 'Baseline', 'description': 'Median nerve thickness will be measured by ultrasound'}, {'measure': 'Median Nerve Thickness', 'timeFrame': '5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention', 'description': 'Median nerve thickness will be measured by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Electromyography', 'timeFrame': 'Baseline', 'description': 'EMG will be used to diagnose carpal tunnel.'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Baseline', 'description': 'It will be used to assess pain intensity.'}, {'measure': 'Visual Analog Scale', 'timeFrame': '5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention', 'description': 'It will be used to assess pain intensity.'}, {'measure': 'Short Form-36', 'timeFrame': 'Baseline', 'description': "It will be used to evaluate patients' quality of life."}, {'measure': 'Short Form-36', 'timeFrame': '5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention', 'description': "It will be used to evaluate patients' quality of life."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Median Nerve Thickness', 'Ultrasound', 'Electromyograpy', 'Physiotherapy', 'ESWT', 'Paraffin'], 'conditions': ['Carpal Tunnel Syndrome (CTS)']}, 'descriptionModule': {'briefSummary': 'The study plans to include a total of 60 patients diagnosed with carpal tunnel syndrome. Patients will be divided into two groups according to the treatment they receive. One group will receive only paraffin treatment, while the other group will receive only ESWT treatment. ESWT will be applied for a total of 5 sessions. Paraffin will be applied for a total of 10 sessions. As assessment tools;\n\n* Measurement of median nerve thickness with ultrasound\n* Electromyography\n* Visual Analog Scale\n* Short Form-36\n\nEvaluations will be made twice by a specialist physician before and after the treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals between the ages of 30-60 who have been diagnosed with CTS by a specialist physician according to international criteria (Those between Stages 1-3),\n* Those who have complaints of numbness, tingling, and pain in the first three fingers and half of the fourth finger,\n* Phalen Test and Tinel sign or Durkan Test being positive\n* Patients who will receive 5 sessions of ESWT application prescribed by a Physical Medicine and Rehabilitation Specialist Physician (for the ESWT group)\n* Patients who have been recommended 10 sessions of Paraffin application by a Physical Medicine and Rehabilitation Specialist Physician (for the Paraffin group)\n\nExclusion Criteria:\n\n* Presence of atrophy in the thenar muscles,\n* Insufficient sensory and motor response in the median nerve,\n* History of hand and/or wrist injury or surgery,\n* Those with cervical stenosis, cervical spondylosis, or cervical radiculopathy,\n* Corticosteroids in the carpal tunnel area within the last six months those who have had an injection,\n* Pregnancy or diabetes, renal failure, rheumatoid arthritis or hypothyroidism'}, 'identificationModule': {'nctId': 'NCT07167667', 'briefTitle': 'Median Nerve Thickness of the Carpal Tunnel Syndrome After Two Different Physiotherapy Modalities', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Investigation of the Effects of Two Different Physiotherapy Modalities on Median Nerve Thickness, Electrophysiological Activity, Pain Intensity and Quality of Life in Patients With Carpal Tunnel Syndrome - An Observational Study', 'orgStudyIdInfo': {'id': '2024/145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paraffin', 'interventionNames': ['Other: Paraffin Bath']}, {'type': 'EXPERIMENTAL', 'label': 'ESWT', 'interventionNames': ['Other: Extracorporeal Shock Wave Therapy']}], 'interventions': [{'name': 'Paraffin Bath', 'type': 'OTHER', 'description': "Patients' hands will be dipped into the paraffin bath 8-10 times.", 'armGroupLabels': ['Paraffin']}, {'name': 'Extracorporeal Shock Wave Therapy', 'type': 'OTHER', 'description': 'The patients will be treated with a sound wave pulse frequency of 15 Hz, an intensity of 1.5 bar, and a total number of pulses of 2000 for one session.', 'armGroupLabels': ['ESWT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Sonbahar Bolat, Physican', 'role': 'CONTACT', 'email': 'esra.sonbahar@hotmail.com', 'phone': '+905052686709'}], 'facility': 'Baltalimani Metin Sabanci Bone Diseases Training and Research Hospita', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Esra Sonbahar Bolat, Physician', 'role': 'CONTACT', 'email': 'esra.sonbahar@hotmail.com', 'phone': '+9005052686709'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emre Şenocak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emre Şenocak', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}