PRP Injections for Shoulder Osteoarthritis
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?
Is PRP injection generally safe for humans?
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.145910
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single injection of low-dose PRP, high-dose PRP, or saline into the glenohumeral joint
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
Treatment Details
Interventions
- High-dose PRP
- Low-dose PRP
- Saline
High-dose PRP is already approved in United States, European Union for the following indications:
- Orthopedic/musculoskeletal indications including osteoarthritis of the knee, ankle, hip, and shoulder
- Orthopedic/musculoskeletal indications including osteoarthritis of the knee, ankle, hip, and shoulder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital for Special Surgery, New York
Lead Sponsor