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NCT Number: NCT05567081

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

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.

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Key information

Conditions

Ulnar Neuropathy at Elbow

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tanta University Hospital

Tanta, Gharbia Governorate, 31511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone Acetonide 40mg/mL

Drug

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

Other names: Epirelefan 40 mg

PRP

Drug

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

Primary outcomes

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

    Time frame: 1, and 3 months after injection

  2. Change in nerve conduction parameters of ulnar nerve at elbow after injection

    Time frame: 1 and 3 months after injection

    Change in ulnar nerve conduction velocity and CMAP across elbow.

Secondary outcomes

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

    Time frame: 1 month after injection

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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