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

Primary Purpose

Ulnar Neuropathy at Elbow

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide 40mg/mL
PRP
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Neuropathy at Elbow

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PRP group

Corticosteroid group

Arm Description

3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve.

Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve.

Outcomes

Primary Outcome Measures

Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
Change in nerve conduction parameters of ulnar nerve at elbow after injection
Change in ulnar nerve conduction velocity and CMAP across elbow.

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2022
Last Updated
October 1, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05567081
Brief Title
Efficacy of Ultrasound-Guided PRP Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow
Official Title
Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
July 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathy at Elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve.
Arm Title
Corticosteroid group
Arm Type
Experimental
Arm Description
Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40mg/mL
Other Intervention Name(s)
Epirelefan 40 mg
Intervention Description
Deep perineural injection with 1cm corticosteroid mixed with 1ml lidocaine hydrochloride.
Intervention Type
Drug
Intervention Name(s)
PRP
Intervention Description
Deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve.
Primary Outcome Measure Information:
Title
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
Time Frame
1, and 3 months after injection
Title
Change in nerve conduction parameters of ulnar nerve at elbow after injection
Description
Change in ulnar nerve conduction velocity and CMAP across elbow.
Time Frame
1 and 3 months after injection
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
1 month after injection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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