Vitamin B12 and Dextrose for Median Nerve Hydrodissection

National Cheng-Kung University Hospital120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasound-guided nerve hydrodissectionPROCEDURE

Peri- median nerve injection for hydrorelease and decompression

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change of Boston Carpal Tunnel Syndrome Questionnaire

Measure the severity of symptoms and functional status before and after treatment

Time frame: Pre-treatment, 1st, 3rd, 6th month after injection

Secondary Outcomes

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.)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Pre-treatment, 1st, 6th month after injection

Central Contacts

Yao-Hong Guo, MD, MSc

CONTACT

886-6-2353535 drprps@gmail.com

Data from ClinicalTrials.gov

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