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Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow: A Randomized Double-blind Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04264000
Enrollment
30
Registered
2020-02-11
Start date
2020-08-01
Completion date
2024-03-31
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulnar Neuropathy at Elbow

Keywords

Ulnar Neuropathy at Elbow, platelet-rich plasma, Perineural injection

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.

Interventions

DRUGplatelet-rich plasma

Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve

Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve

Sponsors

Yung-Tsan Wu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale (VAS)Change from baseline at 6 month after injectionDigital pain severity or paresthesia/dysthesia was evaluated using VAS. Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

Secondary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder and Hand (DASH)Change from baseline at 6 month after injectionTaiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.
Electrophysiological studyChange from baseline at 6 month after injectionNerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Cross-sectional area of ulnar nerveChange from baseline at 6 month after injectionUsing the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026