Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

NCT ID: NCT05317624

Last Updated: 2023-04-04

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

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2023-02-01

Brief Summary

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Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears

Detailed Description

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The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups.

30 patient in each group will be included

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups will be included
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Platelet rich plasma group

participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type COMBINATION_PRODUCT

platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine

Methylprednisolone group

participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type COMBINATION_PRODUCT

1ml methyl prednisolone 40mg\\ml mixed with normal saline and bupivacaine

Interventions

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Platelet rich plasma

platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine

Intervention Type COMBINATION_PRODUCT

Methylprednisolone

1ml methyl prednisolone 40mg\\ml mixed with normal saline and bupivacaine

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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PRP group steroids group

Eligibility Criteria

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Inclusion Criteria

1. Patients with positive tests for rotator cuff pain
2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear

Exclusion Criteria

1. Patient refusal
2. Age less than 20 years.
3. Infection at injection site.
4. Prior surgery on the shoulder joint area.
5. Presence of other associated pathology in the shoulder joint
6. Patients using antiplatelet drugs (aspirin).
7. Contraindications to the use of platelet concentrate
8. Contraindications to the steroids injection
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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radwa saber

Radwa saber

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorreya Fikry

Role: PRINCIPAL_INVESTIGATOR

AlexandriaUniversity

Tarek Sarhan

Role: STUDY_DIRECTOR

AlexandriaUniversity

Locations

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Facility of medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0201491

Identifier Type: -

Identifier Source: org_study_id

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