Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT01081860
Status:
UNKNOWN
Last Update Posted:
2010-04-27
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stiffness of the Skin and Joints in Relation to 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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-26', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint stiffness', 'timeFrame': 'In the 1st month', 'description': 'The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.'}, {'measure': 'Stiffness of the skin', 'timeFrame': 'in the 1st month', 'description': 'Skinstiffness is measured with a suction cup'}], 'secondaryOutcomes': [{'measure': 'Physical activities', 'timeFrame': 'In the 1st month', 'description': 'Boston Questionairre'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carpal tunnel syndrome', 'CTS', 'Skinstiffness', 'Jointstiffness'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve.\n\nThe investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints.\n\nA relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with complaints of:\n\n* Carpal tunnel syndrome\n* Trigger finger\n* Dupuytren contracture\n* an acute trauma to the hand', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian\n* Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand\n\nExclusion Criteria:\n\n* Hypo-/hyperthyroidism\n* Diabetes\n* Arthritis\n* Pregnancy\n* Obesity (BMI \\>30)\n* Anatomical anomalies'}, 'identificationModule': {'nctId': 'NCT01081860', 'acronym': 'STIF-CTS', 'briefTitle': 'Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)', 'orgStudyIdInfo': {'id': 'STIF CTS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carpal tunnel syndrome', 'description': 'Patients with carpal tunnel syndrome'}, {'label': 'Trigger finger', 'description': 'Patients with trigger fingers'}, {'label': 'Dupuytren Contracture', 'description': 'Patients with Dupuytren'}, {'label': 'Trauma to the hand', 'description': 'Patients with an acute trauma to the hand'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3430EM', 'city': 'Nieuwegein', 'state': 'Utrecht', 'country': 'Netherlands', 'contacts': [{'name': 'Bo Verwer', 'role': 'CONTACT', 'email': 'b.verwer@antoniusziekenhuis.nl'}], 'facility': 'St Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'centralContacts': [{'name': 'Bo Verwer', 'role': 'CONTACT', 'email': 'b.verwer@antoniusziekenhuis.nl'}], 'overallOfficials': [{'name': 'A.B. Mink van der Molen, dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'dr. A.B. Mink van der Molen', 'oldOrganization': 'department of plastic surgery St Antonius Hospital'}}}}