Perineural Injection Therapy With Vitamin B12 for Carpal Tunnel Syndrome
| Registry | NCT03802422 |
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| Status | Withdrawn - It is hard to enroll patients due to Covid-19 pandemic. |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Sponsor | Tri-Service General Hospital (TSGH) (Other) |
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| Conditions | Carpal Tunnel Syndrome |
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| Interventions | Vitamin B12, Normal saline (Drug) |
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| Dates | start 2019-04-20, primary completion 2020-04-08, completion 2020-04-08, first posted 2019-01-14, last updated 2020-10-08 |
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| Locations | 1 site in Taiwan |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Vitamin B12 hydrodissection | Experimental | Drug: Vitamin B12 | Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve. |
| Normal saline hydrodissection | Placebo comparator | Drug: Normal saline | Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve. |
- Vitamin B12 (Drug): Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.
- Normal saline (Drug): Ultrasound-guided hydrodissection with 3cc 0.9% normal saline between carpal tunnel and median nerve.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
Sex: All, ages: 20 Years to 80 Years, accepts healthy volunteers
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
+Locations (1)
| Facility | City | Country | Status |
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| Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital | Taipei, Neihu District | Taiwan | |
+Publications
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
+Investigators
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital