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Vitamin B12 and Dextrose for Median Nerve Hydrodissection

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound-guided nerve hydrodissection
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Dextrose

Vitamin B12

Dextrose + Vitamin B12

Arm Description

Outcomes

Primary Outcome Measures

Change of Boston Carpal Tunnel Syndrome Questionnaire
Measure the severity of symptoms and functional status before and after treatment

Secondary Outcome Measures

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.)
Cross-sectional area of the median nerve
Using the ultrasound to measure the cross-sectional area of the median nerve before and after treatment
Median nerve elastography
Using the ultrasound to measure the elastography of the median nerve before and after treatment
Median nerve conduction velocity and amplitude
Antidromic sensory nerve conduction velocity and amplitude of the median nerve before and after treatment

Full Information

First Posted
June 6, 2022
Last Updated
June 14, 2022
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05423028
Brief Title
Vitamin B12 and Dextrose for Median Nerve Hydrodissection
Official Title
The Effects of Vitamin B12 and Dextrose on the Ultrasound-guided Median Nerve Hydrodissection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dextrose
Arm Type
Active Comparator
Arm Title
Vitamin B12
Arm Type
Experimental
Arm Title
Dextrose + Vitamin B12
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided nerve hydrodissection
Intervention Description
Peri- median nerve injection for hydrorelease and decompression
Primary Outcome Measure Information:
Title
Change of Boston Carpal Tunnel Syndrome Questionnaire
Description
Measure the severity of symptoms and functional status before and after treatment
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Outcome Measure Information:
Title
Visual analog scale of pain and tingling
Description
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
Title
Cross-sectional area of the median nerve
Description
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
Title
Median nerve elastography
Description
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
Title
Median nerve conduction velocity and amplitude
Description
Antidromic sensory nerve conduction velocity and amplitude of the median nerve before and after treatment
Time Frame
Pre-treatment, 1st, 6th month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao-Hong Guo, MD, MSc
Phone
886-6-2353535
Ext
2666
Email
drprps@gmail.com
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao-Hong Guo, MD, MSc
Phone
886-6-2353535
Ext
2666
Email
drprps@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Vitamin B12 and Dextrose for Median Nerve Hydrodissection

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