Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

Early Phase 1

Completed

• Conditions: Shoulder Pain
• Interventions: Combination Product: Methylprednisolone; Combination Product: Platelet rich plasma

• Registration Number: NCT05317624
• Lead Sponsor: Alexandria University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2021-07-19
• Study Start: 2021-08-10
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Status Verified: 2022-09
• Primary Completion: 2022-11-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone group	Methylprednisolone	participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.
Platelet rich plasma group	Platelet rich plasma	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.

Primary Outcome Measures

Name	Time	Method
Shoulder pain assesment	4 months	The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)

Secondary Outcome Measures

Name	Time	Method
Assesment of rotator cuff tendon healing	4 months	assesment healing process of tendon using ultrasound technique
Assesment the rate of tear recurrence after shoulder joint injection	4 months	The rate of tear recurrence after 4 months of injection will be assessed using MRI or US
Assesment the failure rate after shoulder joint injection	4 months	failure of relief the symptoms after shoulder joint injection will be recorded
The reinjection rate recording	4 months	the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded
Simple shoulder assessment test	4 months	Functional assessment of shoulder joint will be done using simple sholder assessment test 0= maximal disability 20% -40% = crippled 40% -60% = severe disability 60% -80% = moderate disability 100% = no disability

Trial Locations

Locations (1)

Facility of medicine; 🇪🇬 Alexandria, Egypt