Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-02 @ 2:22 AM
Study NCT ID:
NCT02038205
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2014-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Measurements of the Median Nerve Before and After Splinting for 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': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross sectional area of median nerve using ultrasound', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient-reported outcome measures using NeuroQOL and CTSAQ', 'timeFrame': '6 weeks'}, {'measure': 'Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study', 'timeFrame': '6 weeks'}, {'measure': 'cross sectional area, electrodiagnostic study, age, gender, height, weight, BMI, wrist circumference, wrist width. smoking and handedness as predictors of improvement (or no improvement) in the NeuroQOL and CTSAQ-measured clinical severity scale.', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Those with diagnosis of carpal tunnel syndrome, and healthy control subjects with no symptoms of CTS.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older and;\n* Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index \\> 0.9 where first line therapy is indicated to include nocturnal wrist bracing\n* Control subjects without symptoms of carpal tunnel syndrome.\n\nExclusion Criteria:\n\n* Evidence of severe CTS as seen with electromyographic changes in the body of the muscle\n* Untreated hypothyroidism, Rheumatologic disorders\n* Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles\n* Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.\n* Currently pregnant or \\< 3 months post partum\n* History of wrist, hand fracture or severe trauma to affected hand and/or wrist\n* Known tumor, mass or deformity of the hand/wrist\n* Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms\n* History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation\n* Diagnosed neuromuscular disorders which may complicate CTS diagnosis\n* Implanted electronic device (pacemaker, intrathecal pump/stimulator)\n* Any illness that makes it unsafe for the patient to participate in the study\n* Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation'}, 'identificationModule': {'nctId': 'NCT02038205', 'briefTitle': 'Ultrasonographic Measurements of the Median Nerve Before and After Splinting for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '336315'}}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Nanette Joyce, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}