Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-28 @ 9:26 AM
Study NCT ID:
NCT04491058
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Subsynovial Connective Tissue Thickness 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound', 'timeFrame': 'baseline', 'description': 'To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.'}, {'measure': 'Baseline subsynovial connective tissue thickness', 'timeFrame': 'Baseline', 'description': 'To determine correlations between SSCT thickness and participant characteristics (e.g., age, gender) in patients with carpal tunnel syndrome and healthy subjects. To obtain normative data for SSCT thickness in healthy subjects and patients with carpal tunnel syndrome.'}, {'measure': 'Change in subsynovial connective tissue thickness after 3, 6 and 12 months', 'timeFrame': '3, 6, 12 months', 'description': 'To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).'}, {'measure': 'Change in subsynovial connective tissue thickness after treatment', 'timeFrame': '3, 6, 12 months', 'description': 'To evaluate the effect of treatment (i.e., surgery or infiltration) on SSCT thickness in patients with carpal tunnel syndrome. Orthopedic surgeon decides independently if and which treatment is necessary for the patient. If possible, to subgroup patients according to the correlation between their response to treatment, assessed with electrodiagnostic testing and clinical variables, and (change in) SSCT thickness.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Subsynovial Connective Tissue', 'Ultrasound'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The general aim of this research is to gain insight in the role of SSCT in the etiology and progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and biomechanical characteristics. This eventually may lead to damage of the median nerve. To examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used First, the reliability of the US technique to characterize morphology of the SSCT will be investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS patients to provide descriptive parameters and to describe differences between patients and controls. In the final part a prospective study will be conducted to look at changes of SSCT thickness over time and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with and without carpal tunnel syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For CTS patients\n* Human adults, 18 years and older\n* Complaints compatible with CTS (Katz Hand Diagram\\[31\\] rating of 'classic', 'probable' or 'possible' or typical clinical signs)\n* Indication for electrodiagnostic testing\n* Informed consent to participate\n* For Healthy subjects\n* Human adults, 18 years and older\n* Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram\n* Informed consent to participate\n\nExclusion Criteria:\n\n* Pregnancy\n* History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease\n* Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb"}, 'identificationModule': {'nctId': 'NCT04491058', 'briefTitle': 'Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'S63134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carpal tunnel syndrome patients', 'description': 'Subjects with unilateral or bilateral carpal tunnel syndrome', 'interventionNames': ['Diagnostic Test: SSCT thickness measurement']}, {'label': 'Healthy', 'description': 'Subjects without carpal tunnel syndrome', 'interventionNames': ['Diagnostic Test: SSCT thickness measurement']}], 'interventions': [{'name': 'SSCT thickness measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Thickness measurement with ultrasound', 'armGroupLabels': ['Carpal tunnel syndrome patients', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Elise Robben', 'investigatorAffiliation': 'KU Leuven'}}}}