Mesotherapy In Lateral Epicondylitis

NCT04201249 | Unknown Phase 2 DMC

• 1 other identifier: MILES
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical and functional evaluation

  0, 1, 2, 3 weeks and 6 months

Study Arms (2)

Mesotherapy with piroxicam and lidocaine

ACTIVE COMPARATOR

Drug: Piroxicam, lidocaine

Mesotherapy without piroxicam and lidocaine

SHAM COMPARATOR

Device: Mesotherapy without drug administration

Interventions

Piroxicam, lidocaine DRUG

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

Mesotherapy without drug administration DEVICE

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 without piroxicam and lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Hospital de Santa Maria, Portugal: lead

Study Sites (1)

Hospital de Santa Maria

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Piroxicam; Lidocaine; Mesotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Central Study Contacts

Vitor AS Teixeira

CONTACT

918219891; vitor.as.teixeira@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vitor Teixeira

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: December 1, 2019
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

PT (1)