Vitamin B12 for Carpal Tunnel Syndrome

NCT03802422 | Withdrawn DMC

• 1 other identifier: Vitamin for CTS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Hydrodissection; Vitamin B12

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Vitamin B12 hydrodissection

EXPERIMENTAL

Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.

Drug: Vitamin B12

Normal saline hydrodissection

PLACEBO COMPARATOR

Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.

Drug: Normal saline

Interventions

Vitamin B12 DRUG

Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.

Vitamin B12 hydrodissection

Normal saline DRUG

Ultrasound-guided hydrodissection with 3cc 0.9% normal saline between carpal tunnel and median nerve.

Normal saline hydrodissection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 18809959 RESULT

• 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.

  PMID: 30339737 RESULT

• 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.

  PMID: 30187524 RESULT

• 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.

  PMID: 23566267 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Vitamin B 12; Saline Solution

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 14, 2019
• Study Start: April 20, 2019
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)