Mesotherapy In Lateral Epicondylitis

Last updated: December 16, 2019
Sponsor: Hospital de Santa Maria, Portugal
Overall Status: Active - Recruiting

Phase

2/3

Condition

Tennis Elbow

Treatment

N/A

Clinical Study ID

NCT04201249
MILES
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • other diseases that can alter clinical evaluation detected through history, clinicalexamination, ultrasound or other exams for comorbidities such as carpal tunnelsyndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies,previous elbow surgery or clinically significant or recent trauma, fibromyalgia andmajor 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 acombination 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 totake oral corticosteroids, NSAIDs or receive any other medical intervention during thetreatment period (physical therapy, bandage, mesotherapy and local corticosteroidinjection or a combination of these).

Study Design

Total Participants: 82
Study Start date:
December 01, 2019
Estimated Completion Date:
December 12, 2021

Connect with a study center

  • Hospital de Santa Maria

    Lisboa,
    Portugal

    Active - Recruiting

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