Vitamin B12 and Dextrose for Median Nerve Hydrodissection

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Ultrasound-guided nerve hydrodissection

• Registration Number: NCT05423028
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-07
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose	Ultrasound-guided nerve hydrodissection	-
Vitamin B12	Ultrasound-guided nerve hydrodissection	-
Dextrose + Vitamin B12	Ultrasound-guided nerve hydrodissection	-

Primary Outcome Measures

Name	Time	Method
Change of Boston Carpal Tunnel Syndrome Questionnaire	Pre-treatment, 1st, 3rd, 6th month after injection	Measure the severity of symptoms and functional status before and after treatment

Secondary Outcome Measures

Name	Time	Method
Cross-sectional area of the median nerve	Pre-treatment, 1st, 3rd, 6th month after injection	Using the ultrasound to measure the cross-sectional area of the median nerve before and after treatment
Median nerve conduction velocity and amplitude	Pre-treatment, 1st, 6th month after injection	Antidromic sensory nerve conduction velocity and amplitude of the median nerve before and after treatment
Visual analog scale of pain and tingling	Pre-treatment, 1st, 3rd, 6th month after injection	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.)
Median nerve elastography	Pre-treatment, 1st, 3rd, 6th month after injection	Using the ultrasound to measure the elastography of the median nerve before and after treatment

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University; 🇨🇳 Tainan, Taiwan