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The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy

The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815042
Enrollment
30
Registered
2025-02-07
Start date
2025-02-28
Completion date
2025-12-31
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elbow Tendinopathy

Keywords

Platelet Rich Plasma, Protein Array Analysis, Growth factor, Patient-Rated Tennis Elbow Evaluation

Brief summary

To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition.

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.

Interventions

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.

Sponsors

CHA University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) ScoreBaseline, 1 week, 2 weeks and 4 weeks after the interventionThe 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.

Countries

South Korea

Contacts

Primary ContactKyunghoon Min, MD, PhD.
minkhrm@gmail.com82-31-780-1892
Backup ContactYounji Kim, MD
yunji0114@naver.com82-10-2876-3662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026