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NCT05423028 Clinical Trial

Vitamin B12 and Dextrose for Median Nerve Hydrodissection

Carpal Tunnel Syndrome Clinical Trial

Official title:
The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05423028
Other study ID # NCKUH-11103036
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date December 2024

Study information
Verified date March 2024
Source National Cheng-Kung University Hospital
Contact Yao-Hong Guo, MD, MSc
Phone 886-6-2353535
Email drprps@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Age between 20-80 year-old. - Diagnosis (carpal tunnel syndrome) was confirmed using an electrophysiological study. Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound-guided nerve hydrodissection
Peri- median nerve injection for hydrorelease and decompression

Locations
Country Name City State
Taiwan Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University Tainan

Sponsors (1)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Visual analog scale of pain and tingling Measure the pain and tingling scale before treatment and after treatment. (0 is for not at all pain/tingling, and 100 is for extremely pain/tingling.) Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Cross-sectional area of the median nerve Using the ultrasound to measure the cross-sectional area of the median nerve before and after treatment Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Median nerve elastography Using the ultrasound to measure the elastography of the median nerve before and after treatment Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Median nerve conduction velocity and amplitude Antidromic sensory nerve conduction velocity and amplitude of the median nerve before and after treatment Pre-treatment, 1st, 6th month after injection
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