Vitamin B12 and Dextrose for Median Nerve Hydrodissection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Ultrasound-guided nerve hydrodissection

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yao-Hong Guo, MD, MSc; Phone Number: 2666 886-6-2353535; Email: drprps@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
    • Contact: Yao-Hong Guo, MD, MSc; Phone Number: 2666 886-6-2353535; Email: drprps@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextrose	Procedure: Ultrasound-guided nerve hydrodissection; Peri- median nerve injection for hydrorelease and decompression
Experimental: Vitamin B12	Procedure: Ultrasound-guided nerve hydrodissection; Peri- median nerve injection for hydrorelease and decompression
Experimental: Dextrose + Vitamin B12	Procedure: Ultrasound-guided nerve hydrodissection; Peri- median nerve injection for hydrorelease and decompression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: NCKUH-11103036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No