An Early Phase 1 interventional study of Platelet rich plasma and Methylprednisolone in Shoulder Pain, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Alexandria University · Early Phase 1, Interventional, and Treatment
Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears
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
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.
Combination Product: Methylprednisolone
platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine
Also known as: PRP group
1ml methyl prednisolone 40mg\\ml mixed with normal saline and bupivacaine
Also known as: steroids group
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)
Time frame: 4 months
Assesment of rotator cuff tendon healing
assesment healing process of tendon using ultrasound technique
Time frame: 4 months
Assesment the failure rate after shoulder joint injection
failure of relief the symptoms after shoulder joint injection will be recorded
Time frame: 4 months
The reinjection rate recording
the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded
Time frame: 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
Time frame: 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
Time frame: 4 months
Measurement plasma C-Reactive Protein level
The plasma C- Reactive Protein level will be measured prior to injection and 4 months later on after the procedure
Time frame: 4 months
Measurement the fasting blood glucose level
The fasting blood glucose level will be measure prior to and one week later after injection
Time frame: one week
Assesment the complications after shoulder joint injection
Complications that might occur after shoulder joint injection such as infection, elevated blood sugar, allergy, nerve injury, nausea and vomiting will be recorded
Time frame: 4 months
Measurement the serum cortisol level
Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection
Time frame: one week
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Alexandria University