Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief (PRP)

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

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

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Combination product: Platelet rich plasma; Combination product: Methylprednisolone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21519
    • Facility of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measurement the fasting blood glucose level	The fasting blood glucose level will be measure prior to and one week later after injection	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	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	one week

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 0201491

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No