Vitamin B12 and Dextrose for Median Nerve Hydrodissection
The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
1 other identifier
interventional
120
1 country
1
Brief Summary
Carpal tunnel syndrome is the most common peripheral entrapment neuropathy of the upper limb. Previous experiments found that ultrasound-guided median nerve hydrodissection with 5% dextrose water could ameliorate the condition of carpal tunnel syndrome. Oral administration of vitamin B 12 had been reported to reduce the discomfort from peripheral neuropathy although the level of evidence is not strong. This prospective, double-blind randomized control trial aims to compare the effects of different kinds of the injection agents on carpal tunnel syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2021
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 21, 2024
March 1, 2024
3 years
June 6, 2022
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Boston Carpal Tunnel Syndrome Questionnaire
Measure the severity of symptoms and functional status before and after treatment
Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Outcomes (4)
Visual analog scale of pain and tingling
Pre-treatment, 1st, 3rd, 6th month after injection
Cross-sectional area of the median nerve
Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve elastography
Pre-treatment, 1st, 3rd, 6th month after injection
Median nerve conduction velocity and amplitude
Pre-treatment, 1st, 6th month after injection
Study Arms (3)
Dextrose
ACTIVE COMPARATORVitamin B12
EXPERIMENTALDextrose + Vitamin B12
EXPERIMENTALInterventions
Peri- median nerve injection for hydrorelease and decompression
Eligibility Criteria
You may qualify if:
- Age between 20-80 year-old.
- Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study.
You may not qualify if:
- Previously undergone wrist surgery or steroid injection for CTS
- Thrombocytopenia
- Coagulopathy
- Inflammation status
- Polyneuropathy
- Brachial plexopathy
- Cervical radiculopathy
- Autoimmune disease
- Malignancy
- Pregnancy
- Thoracic outlet syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 21, 2022
Study Start
December 7, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share