Randomized, Double-Blind Study Comparing Mesotherapy with Piroxicam and Lidocaine to Intradermal Dry Needling in Lateral Epicondylitis Treatment

The primary objective of this study is to assess the **efficacy** of mesotherapy with intradermal **piroxicam** and **lidocaine** in comparison with dry needling for the treatment of **lateral epicondylitis**. This evaluation is clinically relevant as it aims to determine a potentially more effective treatment modality for lateral epicondylitis, a common condition that causes significant pain and functional impairment.

Secondary objectives include identifying clinical, functional, ultrasonographic, and biochemical predictors of treatment success or failure and clinical relapse. Additionally, the study aims to assess the safety of mesotherapy with intradermal piroxicam and lidocaine compared to dry needling for the treatment of lateral epicondylitis.

The clinical trial focuses on evaluating the efficacy of mesotherapy with intradermal piroxicam and lidocaine compared to dry needling for the treatment of **lateral epicondylitis**. The study population includes both male and female participants, all of whom are over the age of 18. Participants are required to have a clinical diagnosis of lateral epicondylitis, characterized by pain over the lateral epicondyle, and a visual analogue scale (VAS) score for pain greater than 40mm. Symptoms must have persisted for more than three months. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the efficacy of **mesotherapy** using **piroxicam** and **lidocaine hydrochloride** compared to intradermal dry needling in the treatment of **lateral epicondylitis**. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators are aware of the treatment allocations, thus minimizing bias. The trial is set to commence on October 22, 2024, with an estimated completion date of December 1, 2025, spanning a total duration of approximately 14 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (over 18 years), a clinical diagnosis of lateral epicondylitis, a visual analogue scale (VAS) score for pain greater than 40mm, and symptoms persisting for more than three months. Following successful screening, participants will be randomized into treatment groups. The primary endpoint is the change in pain intensity from baseline, measured by the VAS score, with a reduction of 20/100 considered effective. Secondary endpoints include changes in pain on resisted dorsiflexion and general health evaluation using the SF-36 MH scale at various intervals (1 week, 2 weeks, 3 weeks, 1 month, 3 months, and 6 months).

Participants are expected to be involved in the study for a maximum treatment period of four weeks, with follow-up visits scheduled to monitor progress and collect data on the primary and secondary endpoints. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial is conducted in accordance with ethical standards and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial involves the use of two **experimental medications**: **Piroxicam** and **Lidocaine Hydrochloride**, both administered via **intradermal use**. **Piroxicam** is provided in the form of a **tablet**. The maximum daily dose is 20 mg, with a total dose not exceeding 20 mg over a treatment period of up to 4 weeks. The active substance, **Piroxicam**, is of chemical origin and is utilized for its anti-inflammatory properties in the treatment of lateral epicondylitis.

**Lidocaine Hydrochloride** is administered as a **solution for injection**. The maximum daily dose is 1.5 ml, with a total dose not exceeding 1.5 ml over the same treatment period of up to 4 weeks. **Lidocaine Hydrochloride** is also of chemical origin and is used for its local anesthetic effects, contributing to pain relief in the management of lateral epicondylitis.

Both medications are part of a randomized, double-blind study comparing the efficacy of mesotherapy with these agents against intradermal dry needling. The trial aims to assess the therapeutic benefits of these treatments in patients with lateral epicondylitis. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the treatment protocol.

The efficacy of the clinical trial will be assessed by evaluating changes in pain intensity and general health outcomes in patients with **lateral epicondylitis**. The primary endpoint for efficacy is the change from baseline in pain intensity, measured using a 0-100 Visual Analogue Scale (VAS) score. The treatment will be considered effective if there is a reduction of at least 20 points on the VAS score.

Secondary endpoints include changes from baseline in a three-point scale assessing pain on resisted dorsiflexion of the wrist and third finger, categorized as none, some, or definite. These measurements will be taken at 1 week, 2 weeks, 3 weeks, 1 month, and 3 months. Additionally, changes in general health will be evaluated using the Short Form-36 Mental Health (SF-36 MH) questionnaire at 1 week, 2 weeks, 3 weeks, 1 month, 3 months, and 6 months.

The trial will compare the efficacy of mesotherapy with intradermal piroxicam and lidocaine against intradermal dry needling. The assessments will be conducted at specified intervals to monitor the progression and effectiveness of the treatment over time.