PRP Injections for Shoulder Osteoarthritis

Overseen By Jennifer Cheng

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Plavix, Steroids, Hyaluronic acid

Disqualifiers: Uncontrolled diabetes, HIV, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of platelet-rich plasma (PRP) injections for shoulder osteoarthritis, a condition causing joint pain and stiffness. It compares different doses of PRP to saline to determine the most effective option. Participants who have experienced shoulder pain for over three months, found no relief with treatments like physical therapy, and received temporary relief from specific injections might be suitable candidates. The goal is to determine if PRP offers a better treatment option for those struggling with this type of shoulder pain. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking non-steroidal anti-inflammatory drugs (like ibuprofen) for 2 weeks before and 1 month after the injection. If you have used steroid injections or hyaluronic acid recently, you may also need to wait before participating.

What is the safety track record for these treatments?

Research has shown that platelet-rich plasma (PRP) therapy has been studied for various joint issues, such as osteoarthritis (OA). Studies suggest that PRP can aid in tissue healing and symptom relief. However, safety considerations are important when evaluating treatments like PRP.

High-dose PRP has been associated with some side effects, including possible infections, swelling, allergic reactions, and small lumps. Despite these, PRP remains promising due to its potential benefits.

Low-dose PRP has shown similar side effects, such as infections and swelling. However, patients generally tolerate PRP treatments well. While these side effects can occur, not everyone experiences them.

This trial is in a later phase, indicating that more is known about the treatment's safety. PRP is already used for other conditions, suggesting it has been fairly safe for many patients. Prospective participants should discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using platelet-rich plasma (PRP) injections for shoulder osteoarthritis because they offer a potentially regenerative treatment option. Unlike standard treatments like NSAIDs or corticosteroid injections that mainly relieve pain and reduce inflammation, PRP harnesses the body's own healing properties. With PRP, especially the high-dose variant, a concentrated amount of platelets is introduced into the joint, which may help repair tissues and slow disease progression. This approach could provide longer-lasting relief and improved joint function compared to conventional therapies.

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

This trial will compare the effects of high-dose PRP, low-dose PRP, and a saline control for shoulder osteoarthritis. Research has shown that platelet-rich plasma (PRP) injections can help with various shoulder issues. In some cases of partial rotator cuff tears, PRP led to better results than corticosteroids. Studies also suggest that PRP can improve patient-reported outcomes more effectively than hyaluronic acid for joint problems. High-dose PRP, which participants in this trial may receive, is thought to aid in tissue healing. Low-dose PRP, another treatment option in this trial, has effectively reduced pain and improved function in muscle and joint conditions. Both high-dose and low-dose PRP appear promising for treating osteoarthritis by helping with pain relief and joint function. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 with shoulder osteoarthritis who've had pain for at least 3 months despite trying physical therapy and other conservative treatments. Participants need an email or network access, an MRI of the affected joint, and a pain score of at least 5/10 due to the condition. They must have experienced temporary relief from a diagnostic joint injection. Those on NSAIDs can't join, nor can those involved in workers' comp claims, recent recipients of certain injections or treatments, or individuals with uncontrolled illnesses.

Inclusion Criteria

MRI of the affected joint

I have had pain for over 3 months despite trying treatments like physical therapy.

Email address or network access

Exclusion Criteria

Hyaluronic acid within 6 months of the initial injection

Involved in workers' compensation or active litigation involving the affected joint

I have ongoing cervical health issues that aren't managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of low-dose PRP, high-dose PRP, or saline into the glenohumeral joint

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including ASES Shoulder Score, NRS pain score, PROMIS measures, medication use, and patient satisfaction

12 months

What Are the Treatments Tested in This Trial?

Interventions

• High-dose PRP
• Low-dose PRP
• Saline

Trial Overview

The study tests single injections of two different doses of PRP (Platelet-Rich Plasma) against saline to see which is more effective for shoulder osteoarthritis. Previous studies used low-dose PRP; this one includes both low-dose (~3X concentration) and high-dose PRP to compare outcomes.

How Is the Trial Designed?

Group I: Low-dose PRP Experimental Treatment 1 Intervention

Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).

Group II: High-dose PRP Experimental Treatment 1 Intervention

Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).

Group III: Saline control Placebo Group 1 Intervention

Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

High-dose PRP is already approved in United States, European Union for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• Orthopedic/musculoskeletal indications including osteoarthritis of the knee, ankle, hip, and shoulder

Approved in European Union as Platelet-Rich Plasma for:

• Orthopedic/musculoskeletal indications including osteoarthritis of the knee, ankle, hip, and shoulder

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

Intra-articular injections of platelet-rich plasma (PRP) are considered an effective symptomatic treatment for early to moderate knee osteoarthritis, supported by strong expert agreement and a high level of evidence (1A).

A recommended treatment sequence includes 1-3 PRP injections, and leucocyte-poor PRP is preferred for better outcomes, although many recommendations are based on expert opinion rather than high-level evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts. Eymard, F., Ornetti, P., Maillet, J., et al.[2022]

Autologous platelet-rich plasma (PRP) shows promise in reducing pain from osteoarthritis and may aid in cartilage repair, highlighting its potential therapeutic benefits.

PRP is derived from the patient's own blood and contains a variety of growth factors, but the commercial versions available can vary significantly in composition, which may affect their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial commentary: autologous platelet-rich plasma. Lubowitz, JH.[2018]

Platelet-rich plasma (PRP) significantly stimulates the proliferation of cells from human knee joint tissues and enhances the secretion of superficial zone protein (SZP), which is crucial for cartilage lubrication.

PRP demonstrates effective lubricating properties on bovine articular cartilage, reducing friction to levels comparable to synovial fluid, which supports its potential efficacy in treating osteoarthritis in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. Sakata, R., McNary, SM., Miyatake, K., et al.[2022]

Intra-articular platelet-rich plasma (PRP) injections are likely a safe treatment for Japanese patients with mild-to-moderate knee osteoarthritis, with only minor adverse events reported that resolved quickly.

The treatment showed significant pain relief, with average Visual Analog Scale (VAS) pain scores dropping from 71.6 mm at baseline to 18.4 mm at 6 months, and 80% of patients experiencing a 50% or greater reduction in pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma (PRP) injections for treating knee pain associated with osteoarthritis of the knee in the Japanese population: a phase I and IIa clinical trial. Taniguchi, Y., Yoshioka, T., Kanamori, A., et al.[2018]

In a study involving 60 patients with adhesive capsulitis of the shoulder, a single intra-articular injection of platelet-rich plasma (PRP) was found to be more effective than corticosteroid (CS) injections in reducing pain and improving shoulder function over a 12-week period.

Patients receiving PRP showed greater improvements in pain scores and range of motion compared to those receiving corticosteroids, with no major complications reported, indicating that PRP may be a safer and more effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Intra-articular Platelet-Rich Plasma Versus Corticosteroid Injections in the Treatment of Adhesive Capsulitis of the Shoulder: A Cohort Study. Barman, A., Mukherjee, S., Sahoo, J., et al.[2020]

In a preliminary study of 14 patients with knee osteoarthritis, intraarticular platelet-rich plasma (PRP) injections showed significant improvements in pain and function, with no reported adverse events, indicating a favorable safety profile.

Patients experienced almost linear improvements in their Knee Injury and Osteoarthritis Outcome Scores over 12 months, suggesting that PRP may effectively relieve symptoms of osteoarthritis and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Sampson, S., Reed, M., Silvers, H., et al.[2022]

Autologous platelet-rich plasma (PRP) injections significantly improve pain relief and functional outcomes in patients with common shoulder diseases compared to placebo and corticosteroid injections, based on an analysis of 17 randomized controlled trials.

PRP injections also enhance quality of life (QoL) for patients, with the most effective results seen when PRP is prepared using specific techniques, such as double centrifugation and high platelet concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can platelet-rich plasma injections provide better pain relief and functional outcomes in persons with common shoulder diseases: a meta-analysis of randomized controlled trials. Barman, A., Mishra, A., Maiti, R., et al.[2022]

In a study involving 54 patients with knee osteoarthritis, adding growth hormone (Somatropin) to platelet rich plasma (PRP) injections significantly improved joint function in the first month compared to PRP alone, as measured by the WOMAC score.

Both treatment groups experienced a significant reduction in WOMAC scores after injections, and no complications were reported, indicating that the combined treatment is safe and effective for improving knee function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. Rahimzadeh, P., Imani, F., Faiz, SH., et al.[2022]

Activated platelet-rich plasma (PRP) significantly enhances the proliferation of dermal papilla (DP) cells and stimulates key signaling pathways (ERK and Akt), which are important for hair growth.

In an in vivo study with mice, injections of activated PRP led to a quicker transition from the resting phase (telogen) to the growth phase (anagen) of hair follicles compared to control mice, suggesting its potential effectiveness in promoting hair growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. Li, ZJ., Choi, HI., Choi, DK., et al.[2022]

Intra-knee-articular injections of platelet-rich plasma (PRP) significantly improved knee function and symptoms in patients with cartilage degeneration compared to sodium hyaluronate (SH) after 6 months, indicating better long-term efficacy of PRP.

Both PRP and SH injections were found to be safe, with similar rates of adverse reactions, but PRP showed sustained benefits in alleviating pain and improving quality of life beyond the initial months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. Li, M., Zhang, C., Ai, Z., et al.[2022]

Citations

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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.

sportsmed.org

sportsmed.org/membership/sports-medicine-update/spring-2024/platelet-rich-plasma-for-osteoarthritis-in-2024

Platelet-Rich Plasma for Osteoarthritis in 2024 – More Hype

A statistically significant improvement in patient-reported outcome scores was demonstrated with PRP over HA, while LP-PRP was associated with significantly ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666639125001403

Platelet rich plasma for treatment in the shoulder and elbow

PRP has been shown to be most effective in the management of adhesive capsulitis and lateral epicondylitis.

4.

bmcmusculoskeletdisord.biomedcentral.com

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

Platelet-rich plasma treatment for large joint osteoarthritis

Platelet-rich plasma (PRP) therapy has emerged as a potential treatment option for osteoarthritis (OA) due to its ability to promote tissue healing and anti- ...

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hss.edu

hss.edu/health-library/conditions-and-treatments/list/prp-injections

Platelet-Rich Plasma (PRP) Injection: How It Works

Learn how your own blood can help you heal with PRP injections. This can speed up the healing process in injured tendons & joints.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11295534/

Adverse events related to platelet-rich plasma therapy and ...

PRP therapy may involve several AEs, including postoperative infections, blindness, inflammation, allergic reactions, and nodule development.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11652557/

The Effect of Platelet Dose on Outcomes after Platelet Rich ...

This study aims to systematically review platelet dosage in platelet rich plasma (PRP) injections for common musculoskeletal conditions.