[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05675527":3,"trial-entities:NCT05675527":115,"trial-summary:NCT05675527":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":88,"locations":91,"central_contacts":105,"overall_officials":112,"references":113,"see_also_links":114},"NCT05675527","2022-0720","PRP for Glenohumeral Osteoarthritis","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","RECRUITING","2026-09-01","2025-09","2025-10-06","2023-05-02","Hospital for Special Surgery, New York","OTHER",false,"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.",null,[19],"Shoulder Osteoarthritis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},135,"ESTIMATED",[29,34,37],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","Low-dose PRP","Injection",[31],{"type":30,"name":35,"description":32,"armGroupLabels":36},"High-dose PRP",[35],{"type":14,"name":38,"description":32,"armGroupLabels":39},"Saline",[40],"Saline control",[42],{"measure":43,"description":44,"timeFrame":45},"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\u002Fhigher function.","3 months post-injection",[47,51,54,57,60,63],{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"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.",{"measure":55,"description":56,"timeFrame":50},"PROMIS-Upper Extremity computer adaptive test (CAT)","The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.",{"measure":58,"description":59,"timeFrame":50},"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.",{"measure":61,"description":62,"timeFrame":50},"PROMIS Sleep Disturbance","The PROMIS sleep disturbance measures sleep impairment\u002Fdisturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).",{"measure":64,"description":65,"timeFrame":50},"Patient satisfaction","Patient satisfaction is assessed on a 0-10 scale, with 0 meaning \"not satisfied at all\" and 10 meaning \"very satisfied\".","ALL","18 Years","100 Years",{"inclusion":70,"exclusion":77,"raw_text":87},[71,72,73,74,75,76],"18-100 years old","Average NRS pain greater than or equal to 5\u002F10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and\u002For 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",[78,79,80,81,82,83,84,85,86],"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\u002Fautoinflammatory disease)","Presence of acute fractures or gross mechanical deformities","Concurrent \"uncontrolled\" cervical disorders","Inclusion Criteria:\n\n* 18-100 years old\n* Average NRS pain greater than or equal to 5\u002F10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and\u002For chondral lesion or loss\n* At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy\n* MRI of the affected joint\n* Transient relief of symptoms after a diagnostic intra-articular injection into the joint\n* Email address or network access\n\nExclusion Criteria:\n\n* Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection\n* Prior platelet-rich plasma injection\n* Steroid injection within 3 months of the initial injection\n* Hyaluronic acid within 6 months of the initial injection\n* Involved in workers' compensation or active litigation involving the affected joint\n* History of Plavix use\n* Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune\u002Fautoinflammatory disease)\n* Presence of acute fractures or gross mechanical deformities\n* Concurrent \"uncontrolled\" cervical disorders",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"status":8,"city":94,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":102},"Hospital for Special Surgery","New York","10021","United States",[98],{"name":99,"role":100,"email":101},"Jonathan Kirschner, MD","CONTACT","kirschnerj@hss.edu",{"lat":103,"lon":104},40.71427,-74.00597,[106,108],{"name":99,"role":100,"phone":107,"email":101},"646-714-6327",{"name":109,"role":100,"phone":110,"email":111},"Jennifer Cheng","646-714-6870","chengj@hss.edu",[],[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Osteoarthritis of glenohumeral joint",[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This interventional study plans to enroll 135 participants. It compares the effects of low-dose PRP, high-dose PRP, and saline injections.","completed","PRP for Shoulder Osteoarthritis","This study is looking at how effective Platelet-Rich Plasma (PRP) injections are for shoulder osteoarthritis. Researchers are comparing single injections of low-dose PRP, high-dose PRP, and saline (saltwater) to see which works best. You might be able to join if you are 18 to 100 years old, have shoulder pain from osteoarthritis that's at least 5 out of 10, and your pain has lasted for at least 3 months despite other treatments like physical therapy. Success in this study will be measured by changes in your shoulder pain and function using a score called the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, 3 months after the injection. The current status of this study is unclear.","Participants will be followed for 3 months after their injection to measure their ASES Shoulder Score.",116,"Not specified in the trial record.","Not stated in the trial record.",[31,35,38],"v2"]