PRP vs Corticosteroid Injections for Shoulder Osteoarthritis

(PRP Trial)

Overseen By Kelly Kilcoyne, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Narcotics

Disqualifiers: Diabetes, Inflammatory arthropathies, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for shoulder osteoarthritis: platelet-rich plasma (PRP) injections, which may aid tissue healing, and corticosteroid injections (also known as steroid or cortisone injections), which can reduce pain in the short term. Researchers aim to determine which treatment is more effective for active individuals with ongoing shoulder pain from mild to moderate osteoarthritis that hasn't improved with standard care. Participants must not have had recent shoulder injections or surgeries and should not have diabetes or other specific health conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking narcotics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that platelet-rich plasma (PRP) injections are generally safe and can improve joint movement and reduce pain in people with osteoarthritis (OA). Some studies suggest that PRP might be more effective than other treatments, like hyaluronic acid, for easing symptoms over time. Most people tolerate PRP well, though some side effects can occur. The most common is an infection at the injection site, but this is rare.

Corticosteroid injections also manage pain and swelling in shoulder OA. They provide short-term relief but do not address the root cause of joint problems. Risks include possible damage to nearby tendons.

Overall, both treatments have been studied for safety, but PRP shows promise for longer-lasting benefits in joint health compared to corticosteroids. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about platelet-rich plasma (PRP) injections for shoulder osteoarthritis because they offer a regenerative approach, using components from your own blood to potentially repair tissues. Unlike the standard corticosteroid injections, which primarily reduce inflammation and pain temporarily, PRP leverages growth factors to stimulate healing at the cellular level. Furthermore, PRP may provide longer-lasting relief with fewer side effects, making it an appealing alternative for those seeking more sustainable outcomes.

What evidence suggests that this trial's treatments could be effective for shoulder osteoarthritis?

Research shows that platelet-rich plasma (PRP) injections can reduce pain and improve movement in people with joint problems. Studies have found that PRP significantly eases pain and boosts mobility for those with shoulder arthritis. One study showed pain levels improved by about 49% after six months and 45% after a year. In this trial, participants will receive either PRP injections or corticosteroid injections. PRP has proven more effective than steroid injections for improving shoulder function in the short term. PRP contains substances that help repair tissues, which might explain its positive effects. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to give voluntary informed consent to participate in this investigation

My shoulder arthritis hasn't improved with standard treatments.

I have shoulder pain from mild to moderate arthritis.

Exclusion Criteria

I do not have any serious health conditions that could affect my participation.

Patients with planned deployment or separation from the military within 12 months

I had shoulder surgery within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either corticosteroid or platelet-rich plasma injections

6 weeks

1 visit (in-person) for injection, follow-up visits at 3 weeks and 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up assessments at 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid Injection
• Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure
• Platelet Rich Plasma Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Platelet Rich Plasma Injection Group Experimental Treatment 1 Intervention

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Group II: Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure Experimental Treatment 1 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 Group Active Control 1 Intervention

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

Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in United States as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in Canada as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155124/

The role of platelet-rich plasma in shoulder pathologies In a level 1 study by Kwong et al., P-PRP had superior functional outcomes over CS in the short term (3 months) in 99 patients with partial rotator cuff tears.

2. academic.oup.com academic.oup.com/qjmed/article/116/Supplement_1/hcad069.080/7247805

Effect of Platelet Rich Plasma Therapy for Shoulder ... This study aims to evaluate the efficacy of platelet-rich plasma as a treatment for primary and secondary shoulder osteoarthritis pain.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08663-3

Platelet-rich plasma treatment for large joint osteoarthritis We observed clinically significant improvements in pain (VAS improvement 49% at 6 months, 45% at 12 months) and function (Single Assessment ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424000804

Effectiveness of platelet-rich plasma in partial-thickness ... The findings of our study demonstrated that PRP treatment resulted in a statistically significant reduction in pain compared to the control groups during the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05160441

Comparing Platelet Rich Plasma and Corticosteroid for ... Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424001329

Adverse events related to platelet-rich plasma therapy and ... A meta-analysis showed that, compared with hyaluronic acid, intra-articular injection of PRP could improve pain and function for up to 12 months in patients ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2786501

Effect of Intra-articular Platelet-Rich Plasma vs Placebo ... This randomized trial assesses the effect of injections of platelet-rich plasma vs saline placebo on 12-month changes in knee pain scores and medial.

8. link.springer.com link.springer.com/article/10.1007/s12178-024-09922-x

The Effect of Platelet Dose on Outcomes after ... Clinical studies indicate that a higher dosage may lead to improved outcomes concerning pain relief, functional improvement, and ...