Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

Sponsor

Alexandria University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05317624

Collaborator

(none)

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Combination Product: Platelet rich plasma Combination Product: Methylprednisolone	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups will be included2 groups will be included

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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.

Combination Product: Platelet rich plasma

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

Other Names:

PRP group

Experimental: Methylprednisolone group

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

Combination Product: Methylprednisolone

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

Other Names:

steroids group

Outcome Measures

Primary Outcome Measures

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

Assesment of rotator cuff tendon healing [4 months]
assesment healing process of tendon using ultrasound technique
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
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
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

Other Outcome Measures

Measurement plasma C-Reactive Protein level [4 months]
The plasma C- Reactive Protein level will be measured prior to injection and 4 months later on after the procedure
Measurement the fasting blood glucose level [one week]
The fasting blood glucose level will be measure prior to and one week later after injection
Assesment the complications after shoulder joint injection [4 months]
Complications that might occur after shoulder joint injection such as infection, elevated blood sugar, allergy, nerve injury, nausea and vomiting will be recorded
Measurement the serum cortisol level [one week]
Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection