Vitamin B12 and Dextrose for Median Nerve Hydrodissection

Study Overview
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Brief Summary
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Ultrasound-guided nerve hydrodissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |