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Mesotherapy In Lateral Epicondylitis (MILES)

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ClinicalTrials.gov Identifier: NCT04201249
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Vítor Teixeira, Hospital de Santa Maria, Portugal

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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Drug: Piroxicam, lidocaine Device: Mesotherapy without drug administration Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 12, 2021
Estimated Study Completion Date : December 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mesotherapy with piroxicam and lidocaine 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

Sham Comparator: Mesotherapy without piroxicam and lidocaine 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201249


Contacts
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Contact: Vitor AS Teixeira 918219891 ext 00351 vitor.as.teixeira@gmail.com

Locations
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Portugal
Hospital de Santa Maria Recruiting
Lisboa, Portugal
Contact: Vítor AS Teixeira    918219891 ext 00351    vitor.as.teixeira@gmail.com   
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
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Responsible Party: Vítor Teixeira, Vitor Teixeira, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT04201249    
Other Study ID Numbers: MILES
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Piroxicam
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors