Clinical trial NCT04264000: Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow
Official title: Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow: A Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathy at Elbow
Keywords: Ulnar Neuropathy at Elbow
platelet-rich plasma
Perineural injection
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 30
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: 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.

Detailed description: The platelet-rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Our previous research shown single injection with PRP was superior to D5W for CTS. However there is no study investigating the effect of PRP for UNE now. Hence, the purpose of this study was to assess the effect of perineural PRP injection for UNE.

Eligibility criteria: Inclusion Criteria:

1. Age between 20-80 year-old.
2. Diagnosis as ulnar neuropathy at elbow at least one month

Exclusion Criteria:

1. Cancer
2. Coagulopathy
3. Pregnancy

3. Any active infection status 4. Polyneuropathy of upper extremity 5. Brachial plexopathy 6. Thrombocytopenia Previously undergone wrist surgery or steroid injection for ulnar neuropathy

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Change from baseline at 6 month after injection
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Change from baseline at 6 month after injection
measure: Electrophysiological study
timeFrame: Change from baseline at 6 month after injection
measure: Cross-sectional area of ulnar nerve
timeFrame: Change from baseline at 6 month after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yung-Tsan Wu
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Yung-Tsan Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 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.