Shoulder Osteoarthritis
Conditions
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.
Interventions
BIOLOGICALLow-dose PRP
Injection
BIOLOGICALHigh-dose PRP
Injection
OTHERSaline
Injection
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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-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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactJonathan Kirschner, MD
Backup ContactJennifer Cheng
Outcome results
None listed