Actively Recruiting
Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral Osteoarthritis
Led by Hospital for Special Surgery, New York · Updated on 2025-10-06
135
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of platelet-rich plasma (PRP) injections in patients with glenohumeral osteoarthritis, a common joint condition causing pain and stiffness in the shoulder. This study compares single injections of low-dose PRP, high-dose PRP, and saline (placebo) to better understand their impact on shoulder function and pain. Previous studies focused only on low-dose PRP and lacked a comparison to saline, so this trial aims to fill that gap with a randomized controlled design. Participants will be randomly assigned to receive one injection of either low-dose PRP (3 times the platelet concentration of whole blood), high-dose PRP (12 times the platelet concentration), or saline directly into the glenohumeral joint. The injections are given once, and the study uses triple masking to maintain objectivity. This phase 4 trial monitors outcomes up to 12 months after the injection. During the study, participants will be assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 3 months and other measures like pain rating scales, global health questionnaires, upper extremity function tests, medication use, sleep disturbance, and patient satisfaction up to 12 months after injection. Researchers will track these outcomes to evaluate the treatment effects and safety under medical supervision. Participation involves regular follow-ups and assessments over the year-long observation period.
CONDITIONS
Brief Title
PRP for Glenohumeral Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 100 years
- Average pain score of 5 or higher due to glenohumeral osteoarthritis or related cartilage damage
- Shoulder pain lasting at least 3 months after symptom onset
- Pain that has not improved with conservative treatments including physical therapy
- MRI of the affected shoulder joint available
- Access to email or internet network for communication
You will not qualify if you...
- Unable to stop non-steroidal anti-inflammatory drugs for 2 weeks before and 1 month after injection
- Previous platelet-rich plasma injection in the affected joint
- Steroid injection within 3 months before the study injection
- Hyaluronic acid injection within 6 months before the study injection
- Involvement in workers' compensation or active legal cases related to the affected joint
- History of Plavix medication use
- Uncontrolled systemic illnesses such as diabetes, HIV, vasculitis, or autoimmune/autoinflammatory diseases
- Presence of acute fractures or significant mechanical deformities in the joint
- Uncontrolled cervical spine disorders affecting the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single injection of low-dose PRP, high-dose PRP, or saline into the glenohumeral joint.
1 injection visit (in-person)
Duration - Up to 12 months post-injection
Participants are monitored for outcomes including pain, shoulder function, medication use, sleep disturbance, and satisfaction for up to 12 months after the injection.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
J
Jonathan Kirschner, MD
J
Jennifer Cheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here