Ongoing Clinical Trials for Epicondylitis
There are currently 2 ongoing clinical trials studying new treatments for epicondylitis, commonly known as tennis elbow. These trials are taking place in Portugal and Spain, testing different approaches including mesotherapy, platelet-based injections, and surgical procedures to help reduce pain and improve elbow function in patients with this condition.
Clinical trial locations
- Portugal
- Spain
Study on Mesotherapy with Piroxicam and Lidocaine for Treating Tennis Elbow in Patients
This trial is investigating a treatment approach called mesotherapy for lateral epicondylitis, which causes pain on the outer part of the elbow. The condition often results from overuse of the arm, forearm, and hand muscles, and is commonly seen in athletes and people whose work involves repetitive arm movements.
Who can participate: To join this study, you must be over 18 years old and have a confirmed diagnosis of lateral epicondylitis with pain over the outer part of the elbow. You need to have a pain score greater than 40 out of 100 on a visual scale, and your symptoms must have lasted for more than 3 months. Both men and women can participate.
Who cannot participate: People who do not have lateral epicondylitis cannot join this trial. There are also age restrictions, and certain vulnerable groups are not included in the study.
What the trial is studying: The main goal is to compare two different pain relief methods. The first is mesotherapy, which involves injecting small amounts of piroxicam (an anti-inflammatory medication) and lidocaine (a numbing medication) just under the skin near the affected area. The second method is intradermal dry needling, which uses thin needles to target muscle pain without injecting any medication. Researchers want to see which approach provides better pain relief over time.
What happens during the study: After joining, you will receive either the mesotherapy treatment or the dry needling technique. Your pain levels will be measured at the start using a scale from 0 to 100. You will then have follow-up assessments at 1 week, 2 weeks, 3 weeks, 1 month, 3 months, and finally at 6 months. During these visits, researchers will track changes in your pain levels and overall health using questionnaires.
Investigational drugs: Piroxicam works by blocking enzymes that cause inflammation and pain in the body. Lidocaine helps by numbing the area and blocking pain signals from reaching the brain. Both medications are delivered through mesotherapy, targeting the affected elbow area directly.
Study on Platelet Concentrate for Treating Tennis Elbow in Patients: Comparing Surgery and Injection Methods
This Spanish trial is comparing two different treatment approaches for chronic tennis elbow: a surgical procedure and an injection therapy using a special solution made from the patient’s own blood.
Who can participate: You must be over 18 years old with persistent elbow pain (rated greater than 5 out of 10 on a pain scale) that has lasted at least 3 months. You need a confirmed diagnosis of chronic lateral epicondylitis through ultrasound or MRI. You must be available for follow-up visits for up to 24 months, be able to understand the study details, agree to participate by signing a consent form, and have normal blood test results.
Who cannot participate: You cannot join if you have had previous surgery on the affected elbow, have other elbow conditions that could interfere with results, are currently in another clinical trial, have a known allergy to the study medication, have severe medical conditions, are pregnant or breastfeeding, or are unable to follow study procedures or attend follow-up visits.
What the trial is studying: Researchers are comparing arthroscopic debridement (a surgical procedure that removes damaged tissue through small incisions) with injections of cytokine-rich autologous serum, known as SARC. This serum is prepared from your own blood and contains proteins that may help reduce inflammation and promote healing. The study aims to determine which treatment is more effective at reducing pain over a six-month period.
What happens during the study: Participants are randomly assigned to receive either the surgical procedure or the injection treatment. If you receive SARC injections, you will typically have two injections spaced 14 to 21 days apart. If medical reasons prevent the second injection, you will still be monitored as planned. Throughout the study, you will be watched carefully for any side effects such as infections, fever, or allergic reactions. The entire study is designed to last up to 24 months, with an estimated completion date in September 2027.
Investigational treatments: SARC uses cytokines from your own blood to potentially reduce inflammation and support healing in the damaged tendon. The arthroscopic debridement procedure aims to remove damaged tissue and improve elbow function through minimally invasive surgery.
Summary
These two trials represent different approaches to treating epicondylitis. The Portuguese study focuses on comparing non-surgical injection methods using anti-inflammatory medication versus dry needling, with a follow-up period of 6 months. The Spanish trial takes a broader approach by comparing surgical intervention with a biological treatment derived from the patient’s own blood, with monitoring extending up to 24 months.
Both studies target patients who have experienced chronic symptoms for at least 3 months and require a minimum pain threshold for participation. The Spanish trial is notably more intensive, requiring longer participant commitment and normal blood test results. Both trials aim to provide evidence about which treatments offer the most effective pain relief for this common condition that affects people’s ability to perform daily activities and work tasks.
Patients interested in participating should note that the Portuguese trial uses established pain medications delivered in a targeted way, while the Spanish trial includes both a surgical option and a newer biological approach using the body’s own healing factors. The choice of trial may depend on your location, willingness to consider surgery, and ability to commit to the follow-up schedule.
