Clincosm LogoSign in Get a demo

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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05567081
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13.3
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triamcinolone Acetonide 40mg/mL
  • Drug: PRP
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Apr 21, 2022
Actual Study Completion Date :
Jul 11, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in ultrasound cross sectional area of ulnar nerve at elbow after injection [1, and 3 months after injection]

    2. 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.

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    9. Significant renal or hepatic dysfunction.

    10. Critical thrombocytopenia.

    11. Hemodynamic instability.

    12. Septicemia.

    13. Local infection at the site of the procedure.

    14. Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.

    15. Local injection at the suspected treatment site within the last month.

    16. Recent fever or illness.

    17. Hemoglobin level <10 g/dL.

    18. Platelet dysfunction disorders.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospital Tanta Gharbia Egypt 31511

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hajar Anwer Elnagar, Doctor, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05567081
    Other Study ID Numbers:
    • 34743/6/21
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Oct 5, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ulnar Neuropathies
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    Triamcinolone diacetate

    Study Results

    No Results Posted as of Oct 5, 2022