Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-29 @ 9:31 PM
Study NCT ID:
NCT01102868
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2010-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMS-treatment and Canalis Carpi 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter of the Nervae medianus in the Carpal Tunnel', 'timeFrame': 'End 2011'}], 'secondaryOutcomes': [{'measure': 'Health complaints', 'timeFrame': 'End 2011'}, {'measure': 'Power of the hand grip', 'timeFrame': 'End 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '34391281', 'type': 'DERIVED', 'citation': 'Kvist KB, Hilland R, Enehaug R, Schjelderup J, Lie SA, Halse AK. The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. J Bodyw Mov Ther. 2021 Jul;27:522-528. doi: 10.1016/j.jbmt.2021.03.020. Epub 2021 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery.\n\nIn this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to release the tension of nervus medianus in the lower arm. The study will be performed by randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower arm.', 'detailedDescription': 'The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Canalis Carpi Syndrome verified by ultrasound and clinically\n* Both genders\n* Age from 18 to 67\n\nExclusion Criteria:\n\n* Negative neurophysiology result.\n* Epilepsy,\n* Heart disease,\n* Rheumatism\n* Unstable angina pectoris,\n* Metal -allergy,\n* Needle- phobia,\n* Infection\n* Hemophilia\n* Cognitive problems'}, 'identificationModule': {'nctId': 'NCT01102868', 'briefTitle': 'IMS-treatment and Canalis Carpi Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome', 'orgStudyIdInfo': {'id': 'IMS1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Needle in acupuncture point Li11', 'description': 'Acupuncture needle in the acupuncture point Li11', 'interventionNames': ['Device: Needle in acupuncture point Li11']}, {'type': 'EXPERIMENTAL', 'label': 'IMS of musculus pronator teres', 'description': 'Acupuncture needle in musculus pronator teres', 'interventionNames': ['Device: IMS of the musculus pronator teres']}], 'interventions': [{'name': 'Needle in acupuncture point Li11', 'type': 'DEVICE', 'otherNames': ['Needles'], 'description': 'Acupuncture needle in acupuncture point Li11', 'armGroupLabels': ['Needle in acupuncture point Li11']}, {'name': 'IMS of the musculus pronator teres', 'type': 'DEVICE', 'otherNames': ['Needles'], 'description': 'Acupuncture needle in musculus pronator teres', 'armGroupLabels': ['IMS of musculus pronator teres']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Uni Health, Uni Research', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Stein Atle Lie, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uni Health, University Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}