Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-01 @ 2:18 PM
Study NCT ID:
NCT00803257
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lumbrical Stretching on 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Splint', 'Hand exercises'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '23925936', 'type': 'DERIVED', 'citation': 'Baker NA, Moehling KK, Desai AR, Gustafson NP. Effect of carpal tunnel syndrome on grip and pinch strength compared with sex- and age-matched normative data. Arthritis Care Res (Hoboken). 2013 Dec;65(12):2041-5. doi: 10.1002/acr.22089.'}, {'pmid': '22200381', 'type': 'DERIVED', 'citation': 'Baker NA, Moehling KK, Rubinstein EN, Wollstein R, Gustafson NP, Baratz M. The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Arch Phys Med Rehabil. 2012 Jan;93(1):1-10. doi: 10.1016/j.apmr.2011.08.013.'}]}, 'descriptionModule': {'briefSummary': 'Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Individuals with CTS tend to have tight lumbrical muscles which increase this incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion of the lumbrical muscles should have an effect on the symptoms of CTS.\n\nThe purpose of this study is to systematically examine the effect of an intensive lumbrical muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle exercises, on the symptoms of CTS. This project will be a randomized clinical trial to evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive a home program of lumbrical muscle stretches combined with a night wrist cock-up splint; Group 3 will receive a home program of general stretches combined with a lumbrical positioning splint; and Group 4 will receive a home program of general stretches combined with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be compared to determine if there is a significant reduction in symptoms between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 yo\n* Clinical symptoms of Carpal tunnel syndrome (CTS)\n* Positive Tinel's, Phalen's, or Durkin's test\n* Absence of thenar atrophy\n* 2 pt discrimination of 5mm or less\n\nExclusion Criteria:\n\n* Persons needing immediate CTS surgery\n* Pregnancy\n* Compressive neuropathy in the ipsilateral arm\n* Diabetes\n* prior CTS release\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT00803257', 'briefTitle': 'Effect of Lumbrical Stretching on Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Effect of Lumbrical Stretching on Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '07030166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lumbrical splint and lumbrical stretches', 'interventionNames': ['Other: Lumbrical splint and Lumbrical exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Lumbrical Splint and regular exercises', 'interventionNames': ['Other: Lumbrical splint and Lumbrical exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Regular splint and lumbrical exercises', 'interventionNames': ['Other: Lumbrical splint and Lumbrical exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Regular splint and regular exercises', 'interventionNames': ['Other: Lumbrical splint and Lumbrical exercises']}], 'interventions': [{'name': 'Lumbrical splint and Lumbrical exercises', 'type': 'OTHER', 'description': 'Subjects receive one of four possible interventions - Dose and Frequency are the same for each', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthritis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nancy Baker', 'investigatorAffiliation': 'University of Pittsburgh'}}}}