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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulnar Neuropathy at Elbow

Intervention / Treatment
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* Drug: Triamcinolone Acetonide 40mg/mL
* Drug: PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography. Exclusion Criteria: 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. Recent fever or illness. Hemoglobin level <10 g/dL. Platelet dysfunction disorders.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve. | Drug: PRP<br>* Deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve.<br>|
| Experimental: Corticosteroid group<br>Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve. | Drug: Triamcinolone Acetonide 40mg/mL<br>* Deep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride.<br>* Other names: Epirelefan 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 1 month after injection |