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Study on Platelet Concentrate for Treating Tennis Elbow in Patients: Comparing Surgery and Injection Methods

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of tennis elbow, a condition medically known as lateral epicondylitis. This condition causes pain around the outside of the elbow. The study compares two treatments: a surgical procedure called debridement arthroscopic, which involves cleaning out damaged tissue from the elbow, and an injection treatment using cytokine-rich autologous serum. This serum is a special protein-rich solution made from the patient's own blood.

The purpose of the study is to evaluate how effective these treatments are in reducing pain over a medium-term period of six months. Participants in the study will be randomly assigned to receive either the surgical procedure or the serum injections. Those receiving the serum treatment will have two injections spaced 14 to 21 days apart. If only one injection is given due to medical reasons, the participant will still be monitored as if they had received both injections.

Throughout the study, participants will be closely monitored for any unexpected side effects, such as infections or severe allergic reactions. The study aims to provide valuable information on which treatment is more effective in managing pain for individuals with chronic tennis elbow.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age over 18, persistent pain at the lateral epicondyle for at least 3 months, and a confirmed diagnosis of chronic lateral epicondylitis.

    Informed consent is required, and normal blood test results are necessary.

  2. Step 2

    Treatment with platelet concentrate

    The treatment involves the use of platelet concentrate, which is a component derived from your own blood.

    This is administered through infiltration, which means it is injected directly into the affected area.

  3. Step 3

    Infiltration schedule

    The treatment consists of two infiltrations, spaced 14 to 21 days apart.

    If only one infiltration is performed due to medical reasons, the treatment is considered incomplete, but monitoring and control visits will continue as planned.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring and follow-up visits are scheduled to assess the effectiveness of the treatment and to check for any side effects.

    The main goal is to evaluate pain reduction over a medium-term period of 6 months.

  5. Step 5

    Potential side effects

    Possible side effects include unexpected infections, fever, or serious allergic reactions.

    In case of any side effects, treatment may be adjusted based on medical advice.

  6. Step 6

    Study duration

    The study is designed to last up to 24 months, with the estimated end date being September 3, 2027.

    Participants are expected to be available for the entire duration to ensure comprehensive follow-up.

Who can join the trial?

6 criteria

  • Must be **over 18 years** old.
  • Must have **persistent pain** with a pain level greater than 5 on a scale (VAS > 5) at the side of the elbow, lasting for at least 3 months.
  • Must have a confirmed diagnosis of **chronic lateral epicondylitis**, which is a condition affecting the elbow, confirmed by tests like an ultrasound (ECO) or MRI.
  • Must be available to participate in the study and follow the study plan for up to 24 months.
  • Must be able to understand the study details and agree to participate by signing a consent form.
  • Must have **normal blood test results**.

Who cannot join the trial?

7 criteria

  • Patients who have had surgery on the affected elbow in the past.
  • Patients with other elbow conditions that could affect the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients with a known allergy to the study medication or its components.
  • Patients with severe medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
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Investigated drugs

  • SARC

    is a treatment that uses a special serum made from the patient's own blood. This serum is rich in cytokines, which are proteins that can help reduce inflammation and promote healing. In this trial, SARC is being tested to see if it can effectively reduce pain in patients with chronic lateral epicondylitis, a condition that causes pain in the elbow.

  • Arthroscopic Debridement

    is a surgical procedure used to treat lateral epicondylitis. During this procedure, a surgeon uses small instruments to remove damaged tissue from the elbow joint. This is done through tiny incisions, which helps to reduce pain and improve function in the affected area. The trial is comparing this surgical method to the SARC treatment to determine which is more effective in reducing pain over a six-month period.

What is already known about the treatment

Cytokine-Rich Autologous Serum – This treatment is administered through injection directly into the affected area. It is currently being studied in clinical trials for its effectiveness in treating lateral epicondylitis, commonly known as tennis elbow. The main therapeutic indication is to reduce pain associated with this condition. The mechanism of action involves using the body's own cytokines to promote healing and reduce inflammation. It is classified as a biological therapy.

Investigated diseases

Epicondylitis – Epicondylitis, commonly known as tennis elbow, is a condition characterized by pain and tenderness on the outer part of the elbow. It occurs when the tendons in the elbow are overloaded, usually by repetitive motions of the wrist and arm. The pain may also spread into the forearm and wrist. Over time, the condition can lead to a weakened grip and difficulty in performing tasks that require hand and wrist movements. The progression of epicondylitis can vary, with some individuals experiencing persistent discomfort, while others may notice improvement with rest and changes in activity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515941-40-00Estimated enrolment86 patientsSponsorParc Tauli Hospital Universitari

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).