Mesotherapy In Lateral Epicondylitis

Study Overview
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Brief Summary
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Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.

Official Title
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MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Drug: Piroxicam, lidocaine
* Device: Mesotherapy without drug administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation; A visual analogue scale (VAS) score for pain greater than 40mm; symptoms duration for more than 1 month. Exclusion Criteria: other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions; VAS score for pain less than 40mm; any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion; pregnancy; allergy to any of the study drugs; severely immunosuppressed patients; known coagulopathies. During the study period, enrolled patients are not allowed to take oral corticosteroids, NSAIDs or receive any other medical intervention during the treatment period (physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesotherapy with piroxicam and lidocaine<br> | Drug: Piroxicam, lidocaine<br>* Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam<br>|
| Sham Comparator: Mesotherapy without piroxicam and lidocaine<br> | Device: Mesotherapy without drug administration<br>* Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: visual analogue scale score | pain intensity quantified by using a 0-100 visual analogue scale (VAS) score; a higher score means a higher pain intensity on the VAS | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and functional evaluation | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES-E) score, ranging from 0 to 5 in strenght assessment (0=no contraction; 1=flicker; 2=movement with gravity eliminated; 3=movement against gravity; 4=movement with some resistance; 5=normal power) and from 0-3 in the stability section (0=no instability; 1=mild laxity with good endpoint; 2=moderate laxity no endpoint;3=gross instability) | 0, 1, 2, 3 weeks and 6 months |