Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

Study Overview
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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

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Combination Product: Platelet rich plasma
* Combination Product: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups will be included
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma group<br>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. | Combination Product: Platelet rich plasma<br>* platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine<br>* Other names: PRP group;|
| Experimental: Methylprednisolone group<br>participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline. | Combination Product: Methylprednisolone<br>* 1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine<br>* Other names: steroids group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain assesment | 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) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of rotator cuff tendon healing | assesment healing process of tendon using ultrasound technique | 4 months | 
| Assesment the failure rate after shoulder joint injection | failure of relief the symptoms after shoulder joint injection will be recorded | 4 months | 
| The reinjection rate recording | the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded | 4 months | 
| Assesment the rate of tear recurrence after shoulder joint injection | The rate of tear recurrence after 4 months of injection will be assessed using MRI or US | 4 months | 
| Simple shoulder assessment test | 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 | 4 months |