PRP for Glenohumeral Osteoarthritis

Shoulder Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675527
• Other study ID #: 2022-0720
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Hospital for Special Surgery, New York
• Contact: Jonathan Kirschner, MD
• Phone: 646-714-6327
• Email: kirschnerj[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: February 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

Biological:
• Low-dose PRP
Injection
• High-dose PRP
Injection

Other:
• Saline
Injection

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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