Vitamin B12 and Dextrose for Median Nerve Hydrodissection

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05423028
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 35.8
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Procedure: Ultrasound-guided nerve hydrodissection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
• Actual Study Start Date: Dec 7, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.)

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University	Tainan		Taiwan

Sponsors and Collaborators

• National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT05423028
• Other Study ID Numbers: NCKUH-11103036
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome

Study Results

No Results Posted as of Jun 21, 2022