Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 7:07 AM
Study NCT ID:
NCT03802435
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Sessions of Perineural Injection With Dextrose 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection', 'description': 'Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of pain on 1st, 3rd, 6th, 9th month and one year after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection', 'description': 'Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.'}, {'measure': 'Change from baseline of cross-sectional area of the median nerve on 1st, 3rd, 6th, 9th month and one year after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection', 'description': 'Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.'}, {'measure': 'Change from baseline of electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection', 'timeFrame': 'Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection', 'description': 'Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perineural injection therapy', 'nerve hydrodissection'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '30339737', 'type': 'RESULT', 'citation': 'Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.'}, {'pmid': '28778254', 'type': 'RESULT', '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.'}, {'pmid': '30187524', 'type': 'RESULT', 'citation': 'Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However, the evidence and reference of PIT and nerve hydrodissection are very seldom until our series researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection. However, the accumulative effect and long-term effect (more than 6 months) of PIT is still unknown. Hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is to evaluate the long-term effect and safety of PIT (one year follow-up).', 'detailedDescription': 'After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were includes and randomized into three groups. Group A, patients received two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, nerve conduction velocity of the median nerve, and Global assessment of treatment. The evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-80 year-old.\n* Diagnosis was confirmed using an electrophysiological study\n\nExclusion Criteria:\n\n* Cancer\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': 'NCT03802435', 'briefTitle': 'Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Comparison of Long-term Effect in Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'Different PIT for CTS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two-sessions of ultrasound-guided PIT', 'description': 'two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)', 'interventionNames': ['Procedure: two-sessions of ultrasound-guided PIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One-session of ultrasound-guided PIT', 'description': 'one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)', 'interventionNames': ['Procedure: One-sessions of ultrasound-guided PIT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Two-session of ultrasound-guided nerve hydrodissection', 'description': 'two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).', 'interventionNames': ['Procedure: Placebo ultrasound-guided injection with nerve hydrodissection']}], 'interventions': [{'name': 'two-sessions of ultrasound-guided PIT', 'type': 'PROCEDURE', 'description': 'two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)', 'armGroupLabels': ['Two-sessions of ultrasound-guided PIT']}, {'name': 'One-sessions of ultrasound-guided PIT', 'type': 'PROCEDURE', 'description': 'One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)', 'armGroupLabels': ['One-session of ultrasound-guided PIT']}, {'name': 'Placebo ultrasound-guided injection with nerve hydrodissection', 'type': 'PROCEDURE', 'description': 'Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).', 'armGroupLabels': ['Two-session of ultrasound-guided nerve hydrodissection']}]}, '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 Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Yung-Tsan Wu', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}