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

Ulnar Neuropathy at Elbow Clinical Trial

Official title:

Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567081
• Other study ID #: 34743/6/21
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2021
• Est. completion date: July 11, 2022

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 11, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15

2. Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.

3. History of recent elbow trauma or operation.

4. Malignant neoplasm.

5. Pregnancy.

6. Bleeding Disorders.

7. Factors affecting nerve healing process e.g., tobacco use and systemic corticosteroid administration.

8. Contraindications for PRP injection:

1. Significant renal or hepatic dysfunction.

2. Critical thrombocytopenia.

3. Hemodynamic instability.

4. Septicemia.

5. Local infection at the site of the procedure.

6. Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.

7. Local injection at the suspected treatment site within the last month.

8. Recent fever or illness.

9. Hemoglobin level <10 g/dL.

10. Platelet dysfunction disorders.

Related Conditions & MeSH terms

• Ulnar Neuropathies
• Ulnar Neuropathy at Elbow

Intervention

Drug:
• Triamcinolone Acetonide 40mg/mL
Deep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride.
• PRP
Deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ultrasound cross sectional area of ulnar nerve at elbow after injection		1, and 3 months after injection
Primary	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	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		1 month after injection