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Clinical Trials/NCT05317624
NCT05317624
Completed
Early Phase 1

Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears

Alexandria University1 site in 1 country60 target enrollmentAugust 10, 2021
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ConditionsShoulder Pain

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
Alexandria University
Enrollment
60
Locations
1
Primary Endpoint
Shoulder pain assesment
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
August 10, 2021
End Date
February 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

radwa saber

Radwa saber

Alexandria University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Patient refusal
  • •Age less than 20 years.
  • •Infection at injection site.
  • •Prior surgery on the shoulder joint area.
  • •Presence of other associated pathology in the shoulder joint
  • •Patients using antiplatelet drugs (aspirin).
  • •Contraindications to the use of platelet concentrate
  • •Contraindications to the steroids injection

Outcomes

Primary Outcomes

Shoulder pain assesment

Time Frame: 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 Outcomes

  • Assesment of rotator cuff tendon healing(4 months)
  • Assesment the rate of tear recurrence after shoulder joint injection(4 months)
  • Assesment the failure rate after shoulder joint injection(4 months)
  • The reinjection rate recording(4 months)
  • Simple shoulder assessment test(4 months)

Study Sites (1)

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