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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulnar Neuropathy at Elbow
• Intervention / Treatment: Drug: PRP; Drug: Triamcinolone Acetonide 40mg/mL

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31511
      • Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): April 21, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Ulnar Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 34743/6/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No