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

NCT06815042 | Not Yet Recruiting Phase 4

• 1 other identifier: Bundang_CHA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elbow Tendinopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 week, 2 weeks and 4 weeks after the intervention

Study Arms (1)

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.

Biological: Autologous Platelet-Rich Plasma (PRP) Injection

Interventions

Autologous Platelet-Rich Plasma (PRP) Injection 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.

PRP Treatment Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older
• Diagnosed with elbow tendinopathy
• Persistent pain despite receiving conservative treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

MeSH Terms

Conditions

Elbow Tendinopathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Kyunghoon Min, MD, PhD.

CONTACT

82-31-780-1892; minkhrm@gmail.com

Younji Kim, MD

CONTACT

82-10-2876-3662; yunji0114@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

KR (1)