PRP for Glenohumeral Osteoarthritis

October 1, 2025 updated by: Hospital for Special Surgery, New York

Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jennifer Cheng
  • Phone Number: 646-714-6870
  • Email: chengj@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-100 years old
  • Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss
  • At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy
  • MRI of the affected joint
  • Transient relief of symptoms after a diagnostic intra-articular injection into the joint
  • Email address or network access

Exclusion Criteria:

  • Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection
  • Prior platelet-rich plasma injection
  • Steroid injection within 3 months of the initial injection
  • Hyaluronic acid within 6 months of the initial injection
  • Involved in workers' compensation or active litigation involving the affected joint
  • History of Plavix use
  • Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
  • Presence of acute fractures or gross mechanical deformities
  • Concurrent "uncontrolled" cervical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-dose PRP
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).
Biological: Low-dose PRP
Injection
Experimental: High-dose PRP
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).
Biological: High-dose PRP
Injection
Placebo Comparator: Saline control
Patients will receive a single injection of 6 ml saline into the glenohumeral joint.
Other: Saline
Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: 3 months post-injection
The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.
3 months post-injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average numerical rating scale (NRS) pain score
Time Frame: Up to 12 months post-injection
Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.
Up to 12 months post-injection
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure
Time Frame: Up to 12 months post-injection
The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.
Up to 12 months post-injection
PROMIS-Upper Extremity computer adaptive test (CAT)
Time Frame: Up to 12 months post-injection
The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.
Up to 12 months post-injection
Medication use
Time Frame: Up to 12 months post-injection
Patients will be asked if they are using any of the following medications: non-steroidal anti-inflammatory drugs, opioids, selective serotonin reuptake inhibitors, or neuropathic medications.
Up to 12 months post-injection
PROMIS Sleep Disturbance
Time Frame: Up to 12 months post-injection
The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).
Up to 12 months post-injection
Patient satisfaction
Time Frame: Up to 12 months post-injection
Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".
Up to 12 months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0720

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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