Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

Shoulder Pain Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317624
• Other study ID #: 0201491
• Status: Completed
• Phase: Early Phase 1
• Start date: August 10, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Combination Product:
• Platelet rich plasma
platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine
• Methylprednisolone
1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine

Locations

Country	Name	City	State
Egypt	Facility of medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	4 months
Other	Measurement the fasting blood glucose level	The fasting blood glucose level will be measure prior to and one week later after injection	one week
Other	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	4 months
Other	Measurement the serum cortisol level	Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection	one week
Primary	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	Assesment of rotator cuff tendon healing	assesment healing process of tendon using ultrasound technique	4 months
Secondary	Assesment the failure rate after shoulder joint injection	failure of relief the symptoms after shoulder joint injection will be recorded	4 months
Secondary	The reinjection rate recording	the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded	4 months
Secondary	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
Secondary	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