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

Trial Summary

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 data supports the effectiveness of PRP injections for shoulder osteoarthritis?

Research suggests that platelet-rich plasma (PRP) injections can help reduce pain and improve joint function in conditions like knee osteoarthritis, which may indicate potential benefits for shoulder osteoarthritis as well. ^{1 2 3 4 5}

Is PRP injection generally safe for humans?

Research on PRP injections, particularly for knee osteoarthritis, shows that they are generally safe, with only minor side effects that resolve within 48 hours. ^{1 5 6 7 8}

How is PRP treatment for shoulder osteoarthritis different from other treatments?

PRP (platelet-rich plasma) treatment is unique because it uses a patient's own blood components, specifically platelets, which are rich in growth factors that may help repair cartilage and reduce pain. Unlike standard treatments like corticosteroids, PRP aims to promote healing rather than just alleviate symptoms. ^{1 4 5 9 10}

What is the purpose of this trial?

The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (\~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. [2022]

2. Netherlands 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. [2022]

4. Korea (South) 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Japan 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts. [2022]

10. United States 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. [2020]