Vitamin B12 for Carpal Tunnel Syndrome

October 6, 2020 updated by: Yung-Tsan Wu, Tri-Service General Hospital

Perineural Injection Therapy With Vitamin B12 for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the Vitamin B12 was considered to be beneficial for peripheral neuropathy and pain relief. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection with Vitamin B12 in patients with CTS.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

After obtaining written informed consent, patients with mild to moderate CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with 3cc Vitamin B12 and control side received one-dose ultrasound-guided injection 3cc normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu District
      • Taipei, Neihu District, Taiwan, 886
        • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin B12 hydrodissection
Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.
Drug: Vitamin B12
Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.
Placebo Comparator: Normal saline hydrodissection
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Drug: Normal saline
Ultrasound-guided hydrodissection with 3cc 0.9% normal saline between carpal tunnel and median nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Change from baseline of electrophysiological measurement on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2019

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin for CTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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