Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02809261
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Perineural Injection Therapy in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.', 'timeFrame': 'Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.', 'timeFrame': 'Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment'}, {'measure': 'Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.', 'timeFrame': 'Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment', 'description': 'Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Perineural injection', 'Dextrose'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '21623291', 'type': 'RESULT', 'citation': 'Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.'}, {'pmid': '15138901', 'type': 'RESULT', 'citation': 'Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.'}, {'pmid': '15920223', 'type': 'RESULT', 'citation': 'Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.'}, {'pmid': '28778254', 'type': 'DERIVED', 'citation': 'Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.'}]}, 'descriptionModule': {'briefSummary': 'Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.', 'detailedDescription': 'After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-85 year-old.\n* Diagnosis was confirmed using an electrophysiological study and ultrasonography\n\nExclusion Criteria:\n\nCancer\n\n* Coagulopathy\n* Pregnancy\n* Inflammation status\n* Cervical radiculopathy\n* Polyneuropathy, brachial plexopathy\n* Thoracic outlet syndrome\n* Previously undergone wrist surgery or steroid injection for CTS'}, 'identificationModule': {'nctId': 'NCT02809261', 'briefTitle': 'The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel', 'orgStudyIdInfo': {'id': 'TSGHIRB No: 2-105-05-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perineural injection with 5% dextrose', 'description': 'Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.', 'interventionNames': ['Procedure: Ultrasound-guided perineural injection with 5% dextrose', 'Drug: 5% Dextrose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Perineural injection with normal saline', 'description': 'Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.', 'interventionNames': ['Procedure: Ultrasound-guided perineural injection with normal saline', 'Drug: Normal Saline']}], 'interventions': [{'name': 'Ultrasound-guided perineural injection with 5% dextrose', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.', 'armGroupLabels': ['Perineural injection with 5% dextrose']}, {'name': 'Ultrasound-guided perineural injection with normal saline', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.', 'armGroupLabels': ['Perineural injection with normal saline']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal saline is safe for perineural injection.', 'armGroupLabels': ['Perineural injection with normal saline']}, {'name': '5% Dextrose', 'type': 'DRUG', 'description': '5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.', 'armGroupLabels': ['Perineural injection with 5% dextrose']}]}, '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}}], 'overallOfficials': [{'name': 'Yung-Tsan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital'}]}, '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'}}}}