Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Ulnar Neuropathy at Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264000
• Other study ID #: PRP for ulnar neuropathy
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Ulnar Neuropathies
• Ulnar Neuropathy at Elbow

Intervention

Drug:
• platelet-rich plasma
Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve
• 5% dextrose
Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve

Locations

Country	Name	City	State
Taiwan	Yung-Tsan Wu	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Yung-Tsan Wu

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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 Me — View 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 M — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH)	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.	Change from baseline at 6 month after injection
Secondary	Electrophysiological study	Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.	Change from baseline at 6 month after injection
Secondary	Cross-sectional area of ulnar nerve	Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.	Change from baseline at 6 month after injection