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Platelet-rich Plasma

PRP Injections for Shoulder Osteoarthritis

Phase 4
Recruiting
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-100 years old
Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis and/or chondral lesion or loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-injection
Awards & highlights

Study Summary

This trial will compare treatments for glenohumeral OA: physical activity, injections, medications, low-dose PRP, high-dose PRP and saline injections. Results will determine which is most effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
PRP may cause side effects such as pain at the injection site, tissue damage, infection risk increase due to needle insertion into the joint space, allergic reactions or increased inflammation within the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 100 years old.
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My shoulder pain from arthritis or cartilage loss averages 5/10 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Secondary outcome measures
Average numerical rating scale (NRS) pain score
Medication use
PROMIS Sleep Disturbance
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-dose PRPExperimental Treatment1 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 PRPExperimental Treatment1 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 controlPlacebo Group1 Intervention
Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,767 Total Patients Enrolled

Media Library

High-dose PRP (Platelet-rich Plasma) Clinical Trial Eligibility Overview. Trial Name: NCT05675527 — Phase 4
Shoulder Osteoarthritis Research Study Groups: Low-dose PRP, High-dose PRP, Saline control
Shoulder Osteoarthritis Clinical Trial 2023: High-dose PRP Highlights & Side Effects. Trial Name: NCT05675527 — Phase 4
High-dose PRP (Platelet-rich Plasma) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675527 — Phase 4
Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT05675527 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial accept subjects under 45 years of age?

"This medical study is open to individuals aged 18 and over, up until their centenarian year."

Answered by AI

What safety concerns should be taken into account when utilizing Low-dose PRP treatments?

"As this is a Phase 4 trial, indicating that Low-dose PRP has been approved thus far and so it was given a safety rating of 3."

Answered by AI

Who meets the criteria necessary to join this trial?

"To be eligible for this research study, patients should possess shoulder osteoarthritis and must fall between 18-100 years old. The total expected participants is 135 individuals."

Answered by AI

Are any additional participants being admitted to participate in this research?

"According to the data published on clinicaltrials.gov, this research is not currently accepting patients due to its most recent update being made at the end of December 2022. Nevertheless, there are 594 different medical trials actively recruiting participants presently."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have tried other treatments such PT, NSAIDs without improvement.
PatientReceived 1 prior treatment
~12 spots leftby May 2024