Trial | NCT04201249  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    82
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.
Study Started
Dec 01
2019
Primary Completion
Dec 12
2021
Anticipated
Study Completion
Dec 12
2021
Anticipated
Last Update
Dec 18
2019

Drug Piroxicam, lidocaine [piroxicam (feldene), lidocaine (xylocaine)]

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

Device Mesotherapy without drug administration

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

Mesotherapy with piroxicam and lidocaine Active Comparator

Mesotherapy without piroxicam and lidocaine Sham Comparator

Criteria 

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).
No Results Posted