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Study on Mesotherapy with Piroxicam and Lidocaine for Treating Tennis Elbow in Patients

Verified siteRegistered drugNo placebo
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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 lateral epicondylitis, commonly known as tennis elbow. This condition is characterized by pain on the outer part of the elbow, often caused by overuse of the arm, forearm, and hand muscles. The study will compare two different treatments: mesotherapy using piroxicam and lidocaine hydrochloride, and a technique called intradermal dry needling. Mesotherapy involves injecting small amounts of medication just under the skin, while dry needling uses thin needles to target muscle pain.

The purpose of the study is to assess how effective mesotherapy with piroxicam and lidocaine is compared to dry needling in reducing pain associated with lateral epicondylitis. Participants will receive one of these treatments and will be monitored over a period of time to see how their pain levels change. The study will last for several months, with regular check-ins to evaluate pain reduction and overall health improvements.

Throughout the study, changes in pain intensity will be measured using a visual scale, and general health will be assessed using a questionnaire. The goal is to determine if the mesotherapy treatment can provide significant relief from the symptoms of lateral epicondylitis compared to the dry needling method. This research aims to offer insights into more effective ways to manage and treat this common elbow condition.

The research process

The trial runs in 5 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 specific criteria. Participants must be over 18 years old, have a clinical diagnosis of lateral epicondylitis (pain over the lateral epicondyle), a pain score greater than 40mm on a visual scale, and symptoms lasting more than 3 months.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish a baseline for pain intensity using a visual analogue scale (VAS) ranging from 0 to 100.

  3. Step 3

    Treatment administration

    Participants receive mesotherapy treatment with piroxicam and lidocaine hydrochloride administered intradermally. The treatment is compared to intradermal dry needling.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at 1 week, 2 weeks, 3 weeks, 1 month, and 3 months. These assessments measure changes in pain intensity and general health using a three-point scale and the short form-36 mental health evaluation.

  5. Step 5

    Final evaluation

    A final evaluation is conducted at 6 months to assess long-term changes in pain and general health.

Who can join the trial?

5 criteria

  • Patients must be **older than 18 years**.
  • Must have a **clinical diagnosis of lateral epicondylitis (LE)**, which is pain over the outer part of the elbow that gets worse when touched, when extending the wrist against resistance, or when gripping objects.
  • Must have a **pain score greater than 40mm** on a scale from 0 to 100mm, where 0 means no pain and 100 means the worst pain imaginable.
  • Must have had **symptoms for more than 3 months**.
  • Both **male and female** patients can participate.

Who cannot join the trial?

3 criteria

  • Individuals who are not experiencing lateral epicondylitis cannot participate. This is a condition that causes pain on the outer part of the elbow.
  • Participants must be within a certain age range, typically adults, to be eligible.
  • Both males and females can participate, but certain vulnerable groups are not included.
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Investigated drugs

  • Piroxicam

    is a medication used to reduce pain and inflammation. In this trial, it is delivered through mesotherapy, which involves injecting small amounts of the medication directly into the skin near the affected area. This method aims to provide targeted relief for lateral epicondylitis, a condition characterized by pain in the elbow.

  • Lidocaine

    is a local anesthetic used to numb tissue in a specific area. In this study, it is used alongside piroxicam in mesotherapy to help reduce pain and discomfort associated with lateral epicondylitis. By numbing the area, lidocaine can help provide immediate pain relief.

  • Intradermal Dry Needling

    is a technique that involves inserting thin needles into the skin without injecting any medication. This method is used to stimulate the body's natural healing processes and relieve pain. In this trial, it is compared to mesotherapy with piroxicam and lidocaine to evaluate its effectiveness in treating lateral epicondylitis.

What is already known about the treatment

  • Piroxicam

    Piroxicam is administered through mesotherapy, which involves injecting the medication directly into the skin. It is currently being studied for its effectiveness in treating lateral epicondylitis, commonly known as tennis elbow. The main therapeutic indication is to reduce inflammation and pain associated with this condition. At the molecular level, piroxicam works by inhibiting enzymes involved in the inflammatory process, specifically cyclooxygenase (COX), which reduces the production of substances that cause inflammation and pain. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

  • Lidocaine

    Lidocaine is also administered via mesotherapy, where it is injected into the skin. It is being evaluated for its role in managing lateral epicondylitis. The primary therapeutic use of lidocaine in this context is to provide local anesthesia and pain relief. Its mechanism of action involves blocking sodium channels in nerve cells, which prevents the transmission of pain signals. Lidocaine is classified as a local anesthetic.

Investigated diseases

Lateral Epicondylitis – This condition, often known as tennis elbow, is 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 radiate from the outside of the elbow into the forearm and wrist. Activities such as lifting, gripping, or twisting can exacerbate the discomfort. Over time, the pain can become more persistent and may interfere with daily activities. The condition is common among athletes, particularly those who play racquet sports, but it can also affect individuals who engage in repetitive arm movements in their work or hobbies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519158-34-00Protocol codeCIC-10Estimated enrolment85 patientsSponsorUnidade Local De Saude De Santa Maria E.P.E.

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