Vitamin B12 and Dextrose for Median Nerve Hydrodissection

NCT ID: NCT05423028

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dextrose

Group Type ACTIVE_COMPARATOR

Ultrasound-guided nerve hydrodissection

Intervention Type PROCEDURE

Peri- median nerve injection for hydrorelease and decompression

Vitamin B12

Group Type EXPERIMENTAL

Ultrasound-guided nerve hydrodissection

Intervention Type PROCEDURE

Peri- median nerve injection for hydrorelease and decompression

Dextrose + Vitamin B12

Group Type EXPERIMENTAL

Ultrasound-guided nerve hydrodissection

Intervention Type PROCEDURE

Peri- median nerve injection for hydrorelease and decompression

Interventions

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Ultrasound-guided nerve hydrodissection

Peri- median nerve injection for hydrorelease and decompression

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yao-Hong Guo, MD, MSc

Role: CONTACT

886-6-2353535 ext. 2666

Facility Contacts

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Yao-Hong Guo, MD, MSc

Role: primary

886-6-2353535 ext. 2666

Other Identifiers

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NCKUH-11103036

Identifier Type: -

Identifier Source: org_study_id

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