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High-dose PRP for Shoulder Osteoarthritis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Shoulder OsteoarthritisLow-dose PRP - Biological
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Shoulder Osteoarthritis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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Itacitinib
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JNJ-75348780
1
REGN5093-M114

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 12 months post-injection

3 months post-injection
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Month 12
Average numerical rating scale (NRS) pain score
Medication use
PROMIS Sleep Disturbance
PROMIS-Upper Extremity computer adaptive test (CAT)
Patient satisfaction
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Itacitinib
1
JNJ-75348780
1
REGN5093-M114

Trial Design

3 Treatment Groups

High-dose PRP
1 of 3
Low-dose PRP
1 of 3
Saline control
1 of 3

Experimental Treatment

Non-Treatment Group

135 Total Participants · 3 Treatment Groups

Primary Treatment: High-dose PRP · Has Placebo Group · Phase 4

High-dose PRP
Biological
Experimental Group · 1 Intervention: High-dose PRP · Intervention Types: Biological
Low-dose PRP
Biological
Experimental Group · 1 Intervention: Low-dose PRP · Intervention Types: Biological
Saline control
Other
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months post-injection

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
225 Previous Clinical Trials
60,619 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are within the age range of 18-100 years old.
You experience an average NRS pain score of 5/10 or higher as a consequence of glenohumeral osteoarthritis and/or chondral lesion or loss.
You have experienced persistent pain for a duration of at least 3 months following the initial onset of symptoms and failed to respond to conservative treatments, such as physical therapy.
An MRI of the affected joint has been performed.
You experience temporary relief of symptoms after a diagnostic injection into the joint.
You possess either an email address or access to a network.
References

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