Mesotherapy In Lateral Epicondylitis

Overview

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.

Full Title of Study: “MILES STUDY – Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 12, 2021

Interventions

  • Drug: Piroxicam, lidocaine
    • 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

Arms, Groups and Cohorts

  • Active Comparator: Mesotherapy with piroxicam and lidocaine
  • Sham Comparator: Mesotherapy without piroxicam and lidocaine

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Clinical and functional evaluation
    • Time Frame: 0, 1, 2, 3 weeks and 6 months
    • 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)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Santa Maria, Portugal
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vítor Teixeira, Vitor Teixeira – Hospital de Santa Maria, Portugal
  • Overall Contact(s)
    • Vitor AS Teixeira, 918219891, vitor.as.teixeira@gmail.com

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