Vitamin B12 for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin B12
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Hydrodissection, Vitamin B12
Eligibility Criteria
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
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin B12 hydrodissection
Normal saline hydrodissection
Arm Description
Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Outcomes
Primary Outcome Measures
Change from baseline of severity of symptoms and functional status on 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
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
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
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Full Information
NCT ID
NCT03802422
First Posted
January 9, 2019
Last Updated
October 6, 2020
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03802422
Brief Title
Vitamin B12 for Carpal Tunnel Syndrome
Official Title
Perineural Injection Therapy With Vitamin B12 for Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
It is hard to enroll patients due to Covid-19 pandemic.
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Hydrodissection, Vitamin B12
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B12 hydrodissection
Arm Type
Experimental
Arm Description
Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.
Arm Title
Normal saline hydrodissection
Arm Type
Placebo Comparator
Arm Description
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Intervention Type
Drug
Intervention Name(s)
Vitamin B12
Intervention Description
Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Ultrasound-guided hydrodissection with 3cc 0.9% normal saline between carpal tunnel and median nerve.
Primary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
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.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
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.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Title
Change from baseline of electrophysiological measurement on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd , 3rd and 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
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
18809959
Citation
Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485.
Results Reference
result
PubMed Identifier
30339737
Citation
Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
Results Reference
result
PubMed Identifier
30187524
Citation
Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
Results Reference
result
PubMed Identifier
23566267
Citation
Xu G, Lv ZW, Feng Y, Tang WZ, Xu GX. A single-center randomized controlled trial of local methylcobalamin injection for subacute herpetic neuralgia. Pain Med. 2013 Jun;14(6):884-94. doi: 10.1111/pme.12081. Epub 2013 Apr 8.
Results Reference
result
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Vitamin B12 for Carpal Tunnel Syndrome
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