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NCT Number: NCT05675527

PRP for Glenohumeral Osteoarthritis

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.

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Key information

Conditions

Shoulder Osteoarthritis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Jonathan Kirschner, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose PRP

Biological

Injection

High-dose PRP

Biological

Injection

Saline

Other

Injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Cheng

CONTACT

[email protected]

646-714-6870

Jonathan Kirschner, MD

CONTACT

[email protected]

646-714-6327

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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