Elbow TendinopathyPhase 4NCT06815042
The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP) Injection in people with Elbow Tendinopathy, run by CHA University at 1 site in South Korea.
Trial summary
To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Elbow Tendinopathy
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Diagnosed with elbow tendinopathy
- Persistent pain despite receiving conservative treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, 13496
Kyunghoon Min, MD, PhD., 82-31-780-1892, minkhrm@gmail.com
About this study
To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition.
Read the 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.
- Conditions
- Elbow Tendinopathy
- Being tested
- Autologous Platelet-Rich Plasma (PRP) Injection
- Keywords
- Platelet Rich Plasma, Protein Array Analysis, Growth factor, Patient-Rated Tennis Elbow Evaluation
- Medical subject headings
- Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP) InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment Arm | Experimental | 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. Receives: Biological: Autologous Platelet-Rich Plasma (PRP) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 2 weeks and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815042
- Sponsor's protocol ID
- Bundang_CHA
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT06815042
- Acronym / sponsor ID
- Bundang_CHA
- Conditions
- Elbow Tendinopathy
- Keywords
- Platelet Rich Plasma, Protein Array Analysis, Growth factor, Patient-Rated Tennis Elbow Evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment Arm | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP) InjectionParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 19 years or older
- Diagnosed with elbow tendinopathy
- Persistent pain despite receiving conservative treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP) InjectionParticipants 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. | Biological | PRP Treatment Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP) Injection in people with Elbow Tendinopathy, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyunghoon Min, MD, PhD. (82-31-780-1892, minkhrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Score (time frame: Baseline, 1 week, 2 weeks and 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.