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

Phase 2

Completed

• Conditions: Ulnar Neuropathy at Elbow
• Interventions: Drug: PRP; Drug: Triamcinolone Acetonide 40mg/mL

• Registration Number: NCT05567081
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-04-21
• Study Completion: 2022-07-11
• Study First Submitted: 2022-09-29
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-01
• Last Update Submitted: 2022-10-01
• Study First Posted: 2022-10-05
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP group	PRP	3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve.
Corticosteroid group	Triamcinolone Acetonide 40mg/mL	Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve.

Primary Outcome Measures

Name	Time	Method
Change in nerve conduction parameters of ulnar nerve at elbow after injection	1 and 3 months after injection	Change in ulnar nerve conduction velocity and CMAP across elbow.
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection	1, and 3 months after injection

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 month after injection

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Gharbia, Egypt