The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of Boston Carpal Tunnel Syndrome Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dextrose
Intervention: Ultrasound-guided nerve hydrodissection (Procedure)
Vitamin B12
Intervention: Ultrasound-guided nerve hydrodissection (Procedure)
Dextrose + Vitamin B12
Intervention: Ultrasound-guided nerve hydrodissection (Procedure)
Outcomes
Primary Outcomes
Change of Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: Pre-treatment, 1st, 3rd, 6th month after injection
Measure the severity of symptoms and functional status before and after treatment
Secondary Outcomes
- Cross-sectional area of the median nerve(Pre-treatment, 1st, 3rd, 6th month after injection)
- Median nerve conduction velocity and amplitude(Pre-treatment, 1st, 6th month after injection)
- Visual analog scale of pain and tingling(Pre-treatment, 1st, 3rd, 6th month after injection)
- Median nerve elastography(Pre-treatment, 1st, 3rd, 6th month after injection)