A Phase 4 interventional study of Autologous Platelet-Rich Plasma (PRP) Injection in Elbow Tendinopathy, sponsored by CHA University. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by CHA University · Phase 4, Interventional, and Treatment
To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition.
This study focuses on evaluating the effectiveness and limitations of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a degenerative condition that includes lateral epicondylitis (tennis elbow) and medial epicondylitis (golfer's elbow). These conditions cause pain and reduced function in the elbow, with lateral epicondylitis being more common.
PRP, a regenerative treatment made from the patient's own blood, contains platelets concentrated 3-5 times higher than normal blood, releasing growth factors like TGF-β, PDGF, IGF, and EGF, which help tissue repair. PRP therapy was first introduced for elbow tendinopathy in 2006 and has since been recognized for its potential in pain relief and healing, becoming a reimbursable treatment in Korea since 2023.
However, inconsistent clinical outcomes have been reported due to differences in PRP preparation methods and platelet concentrations. Research suggests that higher platelet counts and specific growth factors may enhance PRP effectiveness. The International Society on Thrombosis \& Haemostasis classifies PRP based on platelet concentration, with some studies indicating that higher levels of TGF-β and IL-1β improve outcomes.
This study aims to identify the key components of PRP that influence treatment success, focusing on platelet concentration and growth factor levels. The goal is to establish optimal PRP preparation guidelines to ensure consistent and effective results for elbow tendinopathy, ultimately improving patient outcomes.
26 studies on the registry are indexed under Elbow Tendinopathy; 9 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 23 interventional studies indexed under Elbow Tendinopathy.
Browse Elbow Tendinopathy studies →CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
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Participants in this arm will receive autologous platelet-rich plasma (PRP) therapy for the treatment of elbow tendinopathy. The PRP is prepared from the patient's own blood and injected into the affected area to evaluate its clinical effectiveness. The study aims to analyze the relationship between PRP composition, including platelet concentration, white blood cell count, and specific growth factors, and treatment outcomes.
Biological: Autologous Platelet-Rich Plasma (PRP) Injection
Participants will receive autologous PRP injections prepared from their own blood to treat elbow tendinopathy. PRP is a plasma product with a 3-5 times higher platelet concentration than normal blood, containing growth factors such as TGF-β, PDGF, IGF, and EGF, which are known to promote tissue repair and regeneration. The PRP will be injected directly into the affected tendon area to evaluate its clinical effectiveness and the relationship between platelet concentration, growth factors, and treatment outcomes.
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
The PRTEE is a validated questionnaire used to assess pain and functional disability in patients with elbow tendinopathy. It consists of 15 items divided into pain (5 items) and function (10 items). Scores range from 0 to 100, with higher scores indicating more severe pain and functional impairment. A decrease in score reflects improvement in symptoms.
Time frame: Baseline, 1 week, 2 weeks and 4 weeks after the intervention
Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
CHA University