Vitamin B12 for Carpal Tunnel Syndrome

Sponsor

Tri-Service General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03802422

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Drug: Vitamin B12 Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Perineural Injection Therapy With Vitamin B12 for Carpal Tunnel Syndrome

Actual Study Start Date :

Apr 20, 2019

Actual Primary Completion Date :

Apr 8, 2020

Actual Study Completion Date :

Apr 8, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection [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.

Secondary Outcome Measures

Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection [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.
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection [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.
Change from baseline of electrophysiological measurement on 2nd week, 1st, 2nd, 3rd and 6th month after injection [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District	Taiwan	886

Sponsors and Collaborators

Tri-Service General Hospital

Investigators

Principal Investigator: Yung-Tsan Wu, MD, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

ClinicalTrials.gov Identifier:

NCT03802422

Other Study ID Numbers:

Vitamin for CTS

First Posted:

Jan 14, 2019

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Hydrodissection

Vitamin B12

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Vitamin B 12

Hydroxocobalamin

Study Results

No Results Posted as of Oct 8, 2020