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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05567081
Other study ID # 34743/6/21
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02986906 - Perineural Injection Therapy for Ulnar Neuropathy at Elbow N/A
Completed NCT04264000 - Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow N/A