Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-29 @ 3:15 PM
Study NCT ID:
NCT02801461
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of ESWT for Cubital Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020430', 'term': 'Cubital Tunnel Syndrome'}], 'ancestors': [{'id': 'D020424', 'term': 'Ulnar Neuropathies'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017769', 'term': 'Ulnar Nerve Compression Syndromes'}, {'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': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment', 'timeFrame': 'Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'Visual analog scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks', 'timeFrame': 'Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'Using the Disabilities of the Arm, Shoulder and Hand to measure the symptoms and functional status before treatment and multiple time frame after treatment.'}, {'measure': 'Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks', 'timeFrame': 'Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cubital Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '26610183', 'type': 'BACKGROUND', 'citation': 'Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10.'}, {'pmid': '21547883', 'type': 'BACKGROUND', 'citation': 'Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wustner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4.'}]}, 'descriptionModule': {'briefSummary': 'The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on cubital tunnel syndrome.', 'detailedDescription': 'Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.\n\nPatients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 20-80 year-old.\n2. Typical symptoms and signs of cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.\n\nExclusion Criteria:\n\n1. Cancer\n2. Coagulopathy\n3. Pregnancy\n4. Inflammation status\n5. Patients who had conditions mimicking cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome."}, 'identificationModule': {'nctId': 'NCT02801461', 'briefTitle': 'The Effect of ESWT for Cubital Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'TSGHIRB: 2-105-05-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Three-sessions of ESWT', 'description': 'ESWT was given once a week for 3 weeks.', 'interventionNames': ['Device: extracorporeal shock wave therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One-session of ESWT', 'description': 'Single ESWT was given.', 'interventionNames': ['Device: extracorporeal shock wave therapy']}], 'interventions': [{'name': 'extracorporeal shock wave therapy', 'type': 'DEVICE', 'description': 'Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\\< 10 ns) and short duration (10 μs).', 'armGroupLabels': ['One-session of ESWT', 'Three-sessions of ESWT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'state': 'Neihu District', 'country': 'Taiwan', 'facility': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician of physical medicine and rehabilitation', 'investigatorFullName': 'Yung-Tsan Wu', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}