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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Saline control | Placebo Comparator | Patients will receive a single injection of 6 ml saline into the glenohumeral joint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose PRP | Biological | Injection |
| |
| High-dose PRP |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Kirschner, MD | Contact | 646-714-6327 | kirschnerj@hss.edu | |
| Jennifer Cheng | Contact | 646-714-6870 | chengj@hss.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Biological |
Injection |
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| Saline | Other | Injection |
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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 |
| D017670 |
| Sodium Compounds |