Clinical trial NCT03802422: Vitamin B12 for Carpal Tunnel Syndrome
Official title: Perineural Injection Therapy With Vitamin B12 for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Hydrodissection
Vitamin B12
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary outcomes:
measure: Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
measure: Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
measure: Change from baseline of electrophysiological measurement on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.