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Corticosteroid

PRP vs Corticosteroid Injections for Shoulder Osteoarthritis (PRP Trial)

Phase 3

Recruiting

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 18 to 70 years (inclusive)

Glenohumeral joint osteoarthritis that has been refractory to standard care treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Awards & highlights

PRP Trial Summary

This trial is testing whether a new treatment, platelet-rich plasma (PRP) derived from autologous blood, is effective in treating shoulder OA in young active duty and civilian populations.

Who is the study for?

This trial is for men and women aged 18-70 with shoulder pain from mild to moderate osteoarthritis that hasn't improved with standard treatments. They must not have had recent injections or surgery in the affected shoulder, be pregnant, or have conditions like diabetes, fibromyalgia, chronic fatigue syndrome, or a history of bad reactions to PRP or corticosteroids.Check my eligibility

What is being tested?

The study compares three non-surgical treatments for shoulder osteoarthritis: Platelet Rich Plasma (PRP) injection, Corticosteroid injection, and delayed PRP after Corticosteroid failure. It aims to find out which treatment might best help young active people avoid surgery by improving tissue healing.See study design

What are the potential side effects?

Possible side effects include pain at the injection site, infection risk increase due to the procedure itself. For corticosteroids specifically there's potential tendon weakening near the joint. PRP generally has fewer side effects as it uses patient's own blood components.

PRP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My shoulder arthritis hasn't improved with standard treatments.

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I have shoulder pain from mild to moderate arthritis.

PRP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in range of motion (ROM) from before injection to after injection

Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before injection to after injection

Change in the Single Assessment Numeric Evaluation (SANE) from before injection to after injection

+3 more

PRP Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Platelet Rich Plasma Injection GroupExperimental Treatment1 Intervention

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Group II: Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection FailureExperimental Treatment1 Intervention

If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection.

Group III: Corticosteroid Injection GroupActive Control1 Intervention

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma Injection

2016

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoFED

102 Previous Clinical Trials

22,116 Total Patients Enrolled

Brooke Army Medical CenterFED

119 Previous Clinical Trials

25,959 Total Patients Enrolled

Uniformed Services University of the Health SciencesFED

116 Previous Clinical Trials

91,013 Total Patients Enrolled

Media Library

Corticosteroid Injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05160441 — Phase 3

Shoulder Osteoarthritis Research Study Groups: Platelet Rich Plasma Injection Group, Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure, Corticosteroid Injection Group

Shoulder Osteoarthritis Clinical Trial 2023: Corticosteroid Injection Highlights & Side Effects. Trial Name: NCT05160441 — Phase 3

Corticosteroid Injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160441 — Phase 3

Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT05160441 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can octogenarians participate in this experiment?

"This trial is open to adults aged 18-70."

Answered by AI

If I meet the qualifications, could I enroll in this research project?

"To be eligible for this clinical trial, potential participants must experience pain and fall in the age demographic of 18 to 70. A total of 600 individuals are being enrolled in the study."

Answered by AI

Are PRP injections associated with high levels of risk?

"There is some efficacy data and multiple rounds of safety data, so on our scale at Power, we rate the Platelet Rich Plasma Injection as a 3."

Answered by AI

Are we currently enrolling patients for this research?

"The clinical trial in question, while no longer recruiting patients, was actively doing so at some point in the past. As it stands, 1007 other trials are still seeking participants."

Answered by AI

Who else is applying?

What state do they live in?

Virginia

Ohio

Pennsylvania

How old are they?

18 - 65

65+

What site did they apply to?

Walter Reed National Military Medical Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Prolonging ever needing a shoulder replacement and would like to gain full range of motion of arm/shoulder.

PatientReceived no prior treatments

I’ve had shoulder pain for more than 6 months with new improvement. Have had an mri that shows inflammation and fraying in my right shoulder.

PatientReceived 1 prior treatment

I have suffered from OA for many years and have tried all of conservative treatments (anti-inflamitorries, cortisone, REST, surgery on my left shoulder (that was not entirely helpful).

PatientReceived 2+ prior treatments