Health TrialsbyHealthPanel

PRP for Glenohumeral Osteoarthritis

ConditionShoulder Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHospital for Special Surgery, New York

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-dose PRP

    Biological/Vaccine

    Injection

  • High-dose PRP

    Biological/Vaccine

    Injection

  • Saline

    Other intervention

    Injection

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: Low-dose PRPExperimental treatment 1 intervention
Group B: High-dose PRPExperimental treatment 1 intervention
Group C: Saline controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months post-injection

Secondary outcomes

1

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.

Time frame
Up to 12 months post-injection
2

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.

Time frame
Up to 12 months post-injection
3

PROMIS-Upper Extremity computer adaptive test (CAT)

The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.

Time frame
Up to 12 months post-injection
4

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.

Time frame
Up to 12 months post-injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Source ClinicalTrials.gov
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