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RecruitingNCT05423028Updated Mar 21, 2024

Vitamin B12 and Dextrose for Median Nerve Hydrodissection

An interventional study of Ultrasound-guided nerve hydrodissection in Carpal Tunnel Syndrome, sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Dec 2021, registered Jun 2022).
  • Started Dec 2021; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Dextrose

    Procedure: Ultrasound-guided nerve hydrodissection

  • Experimental
    Vitamin B12

    Procedure: Ultrasound-guided nerve hydrodissection

  • Experimental
    Dextrose + Vitamin B12

    Procedure: Ultrasound-guided nerve hydrodissection

Interventions

  • ProcedureUltrasound-guided nerve hydrodissection

    Peri- median nerve injection for hydrorelease and decompression

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
    Tainan, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05423028
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Jun 21, 2022
Start date
Dec 7, 2021
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 21, 2024

Study contacts

Yao-Hong Guo, MD, MSc
Contact
drprps@gmail.com
886-6-2353535 ext. 2666

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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