Efficacy of Ultrasound-Guided PRP Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow

NCT05567081 | Completed Phase 2

• 1 other identifier: 34743/6/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology \& Rehabilitation Department, Faculty of Medicine, Tanta University. Patients were be randomly divided into 2 groups: Group I: will undergo a single ultrasound-guided deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. PRP will be prepared by PRP method. Group II: will undergo a single ultrasound-guided deep perineural injection with 1ml corticosteroid (triamcinolone acetonide, 40mg/mL) mixed with 1ml lidocaine hydrochloride.

Conditions

Ulnar Neuropathy at Elbow

Outcome Measures

Primary Outcomes (2)

• Change in ultrasound cross sectional area of ulnar nerve at elbow after injection

  1, and 3 months after injection

• Change in nerve conduction parameters of ulnar nerve at elbow after injection

  Change in ulnar nerve conduction velocity and CMAP across elbow.

  1 and 3 months after injection

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 month after injection

Study Arms (2)

PRP group

EXPERIMENTAL

3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve.

Drug: PRP

Corticosteroid group

EXPERIMENTAL

Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve.

Drug: Triamcinolone Acetonide 40mg/mL

Interventions

Triamcinolone Acetonide 40mg/mL DRUG

Deep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride.

Also known as: Epirelefan 40 mg

Corticosteroid group

PRP DRUG

Deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve.

PRP group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography.

You may not qualify if:

• Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15
• Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.
• History of recent elbow trauma or operation.
• Malignant neoplasm.
• Pregnancy.
• Bleeding Disorders.
• Factors affecting nerve healing process e.g., tobacco use and systemic corticosteroid administration.
• Contraindications for PRP injection:
• Significant renal or hepatic dysfunction.
• Critical thrombocytopenia.
• Hemodynamic instability.
• Septicemia.
• Local infection at the site of the procedure.
• Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.
• Local injection at the suspected treatment site within the last month.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 31511, Egypt

Location

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: June 1, 2021
• Primary Completion: April 21, 2022
• Study Completion: July 11, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

EG (1)