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

NCT ID: NCT06815042

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elbow Tendinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Autologous Platelet-Rich Plasma (PRP) Injection

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CHA University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kyunghoon Min, MD, PhD.

Role: CONTACT

82-31-780-1892

Younji Kim, MD

Role: CONTACT

82-10-2876-3662

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kyunghoon Min, MD, PhD.

Role: primary

82-31-780-1892

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bundang_CHA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.