Shoulder OsteoarthritisPhase 4NCT05675527
PRP for Glenohumeral Osteoarthritis
A Phase 4 study testing Low-dose PRP, High-dose PRP and Saline in people with Shoulder Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Low-dose PRP, High-dose PRP and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 1 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
- Presence of acute fractures or gross mechanical deformities
- Concurrent "uncontrolled" cervical disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Jonathan Kirschner, MD, kirschnerj@hss.edu
About this study
Official title: 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.
- Conditions
- Shoulder Osteoarthritis
- Being tested
- Low-dose PRP, High-dose PRP, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose PRPBiological
Injection
High-dose PRPBiological
Injection
SalineOther
Injection
| Study group | Role | What they receive |
|---|---|---|
| Low-dose PRP | Experimental | 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). Receives: Biological: Low-dose PRP |
| High-dose PRP | Experimental | 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). Receives: Biological: High-dose PRP |
| Saline control | Placebo comparator | Patients will receive a single injection of 6 ml saline into the glenohumeral joint. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
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.
Measured: 3 months post-injection
Secondary outcomes (6)
Average numerical rating scale (NRS) pain score
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.
Measured: Up to 12 months post-injection
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure
The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.
Measured: Up to 12 months post-injection
PROMIS-Upper Extremity computer adaptive test (CAT)
The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.
Measured: Up to 12 months post-injection
Medication use
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.
Measured: Up to 12 months post-injection
PROMIS Sleep Disturbance
The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).
Measured: Up to 12 months post-injection
Patient satisfaction
Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".
Measured: Up to 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start2 May 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675527
- Sponsor's protocol ID
- 2022-0720
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05675527
- Acronym / sponsor ID
- 2022-0720
- Conditions
- Shoulder Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose PRP | Experimental | Biological: Low-dose PRPPatients 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). |
| High-dose PRP | Experimental | Biological: High-dose PRPPatients 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). |
| Saline control | Placebo comparator | Other: SalinePatients will receive a single injection of 6 ml saline into the glenohumeral joint. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose PRPInjection | Biological | Low-dose PRP |
| High-dose PRPInjection | Biological | High-dose PRP |
| SalineInjection | Other | Saline control |
Primary outcome
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.
6 secondary outcomes
Average numerical rating scale (NRS) pain score
Time frame: 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
PROMIS-Upper Extremity computer adaptive test (CAT)
Time frame: Up to 12 months post-injection
Medication use
Time frame: Up to 12 months post-injection
PROMIS Sleep Disturbance
Time frame: Up to 12 months post-injection
Patient satisfaction
Time frame: Up to 12 months post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose PRP, High-dose PRP and Saline in people with Shoulder Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Kirschner, MD (646-714-6327, kirschnerj@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: 3 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.