PRP for Glenohumeral Osteoarthritis
- Conditions
- Shoulder Osteoarthritis
- Interventions
- Biological: Low-dose PRPOther: SalineBiological: High-dose PRP
- Registration Number
- NCT05675527
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose PRP Low-dose PRP 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). Saline control Saline Patients will receive a single injection of 6 ml saline into the glenohumeral joint. High-dose PRP High-dose PRP 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).
- Primary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeons (ASES) Shoulder Score 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 Outcome Measures
Name Time Method PROMIS-Upper Extremity computer adaptive test (CAT) Up to 12 months post-injection The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.
Medication use 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.
Average numerical rating scale (NRS) pain score 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.
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure 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.
PROMIS Sleep Disturbance 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).
Patient satisfaction 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".
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States