PRP for Glenohumeral Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Shoulder Osteoarthritis

Intervention / Treatment
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* Biological: Low-dose PRP
* Biological: High-dose PRP
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose PRP<br>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<br>* Injection<br>|
| Experimental: High-dose PRP<br>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<br>* Injection<br>|
| Placebo Comparator: Saline control<br>Patients will receive a single injection of 6 ml saline into the glenohumeral joint. | Other: Saline<br>* Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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. | Up to 12 months post-injection |