NCT04264000|CompletedDMC
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Sponsor study identifier
interventional
30
1 country
1
Study Start
August 1, 2020
Actual (reported)Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy after carpal tunnel syndrome (CTS). Although many conservative managements of UNE were found, their effectiveness were often unsatisfied without existed guideline. Recently, the perineural injection of 5% dextrose wate (D5W) is a novel management for CTS but its effect for UNE is not obviously as CTS. Hence, it is very important to find another novel injectate for UNE.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2020
Actual (reported)February 11, 2020
Actual (reported)August 1, 2020
Actual (reported)March 31, 2024
Actual (reported)March 31, 2024
Actual (reported)Visual analog scale (VAS)
Digital pain severity or paresthesia/dysthesia was evaluated using VAS. Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline at 6 month after injection
Disabilities of the Arm, Shoulder and Hand (DASH)
Change from baseline at 6 month after injection
Electrophysiological study
Change from baseline at 6 month after injection
Cross-sectional area of ulnar nerve
Change from baseline at 6 month after injection
The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy
The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy
Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve
Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve
Yung-Tsan Wu
Taipei, Neihu District, 886, Taiwan
Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Nov;13(11):2009-2017. doi: 10.1002/term.2950. Epub 2019 Aug 20.
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.
Yung-Tsan Wu
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2020
First Posted
February 11, 2020
Study Start
August 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Huang GS, Chen LC. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial. Sci Rep. 2017 Dec;7(1):94. doi: 10.1038/s41598-017-00224-6. Epub 2017 Mar 7.
Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)Last Updated
April 10, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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