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

NCT ID: NCT05567081

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-07-11

Brief Summary

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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.

Detailed Description

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Conditions

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Ulnar Neuropathy at Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP group

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

Group Type EXPERIMENTAL

PRP

Intervention Type DRUG

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

Corticosteroid group

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

Group Type EXPERIMENTAL

Triamcinolone Acetonide 40mg/mL

Intervention Type DRUG

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

Interventions

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Triamcinolone Acetonide 40mg/mL

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

Intervention Type DRUG

PRP

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

Intervention Type DRUG

Other Intervention Names

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Epirelefan 40 mg

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Hajar Anwer Elnagar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospital

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34743/6/21

Identifier Type: -

Identifier Source: org_study_id

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