The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Kyunghoon Min, MD, PhD.
- Phone Number: 82-31-780-1892
- Email: minkhrm@gmail.com
Study Contact Backup
- Name: Younji Kim, MD
- Phone Number: 82-10-2876-3662
- Email: yunji0114@naver.com
Study Locations
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
- Bundang CHA Medical Center
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Contact:
- Kyunghoon Min, MD, PhD.
- Phone Number: 82-31-780-1892
- Email: minkhrm@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 19 years or older
- Diagnosed with elbow tendinopathy
- Persistent pain despite receiving conservative treatment
Exclusion Criteria:
- Individuals with systemic infection at the time of study participation
- Patients with rheumatic diseases or inflammatory disorders
- Individuals with unstable systemic conditions affecting the cardiovascular, gastrointestinal, respiratory, or endocrine systems
- Any other cases deemed inappropriate for study participation by the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP Treatment Arm
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
Time Frame: Baseline, 1 week, 2 weeks and 4 weeks after the intervention
|
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.
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Baseline, 1 week, 2 weeks and 4 weeks after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bundang_CHA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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