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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Clinic De Barcelona Barcelona Spain
Plit Trqvv Heysvzit Uhhwylgfvygo Sabadell Spain
Hbbcdhvw Vxfv dtrzpdwb Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
02.09.2024

Trial locations

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.

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 ID:
2024-515941-40-00
NCT ID:
NCT04194710
Trial Phase:
Therapeutic confirmatory (Phase III)

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