Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Not Applicable

Completed

• Conditions: Ulnar Neuropathy at Elbow
• Interventions: Drug: platelet-rich plasma; Drug: 5% dextrose

• Registration Number: NCT04264000
• Lead Sponsor: Yung-Tsan Wu

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.

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Start: 2020-08-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet-rich plasma	platelet-rich plasma	The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy
5% dextrose	5% dextrose	The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Change from baseline at 6 month after injection	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.

Secondary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand (DASH)	Change from baseline at 6 month after injection	Taiwan 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 study	Change from baseline at 6 month after injection	Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Cross-sectional area of ulnar nerve	Change from baseline at 6 month after injection	Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

Yung-Tsan Wu; 🇨🇳 Taipei, Neihu District, Taiwan