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

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What is this study about?

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.

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 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 treatment administration

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

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 final evaluation

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

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

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

Trial status

Country Status Recruitment Start
Portugal Portugal
Recruiting
22.10.2024

Trial locations

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.

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 ID:
2024-519158-34-00
Protocol code:
CIC-10
Trial Phase:
Therapeutic exploratory (Phase II)

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