Mesotherapy In Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

— MILES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201249
• Other study ID #: MILES
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2019
• Est. completion date: December 12, 2021

Study information

• Verified date: December 2019
• Source: Hospital de Santa Maria, Portugal
• Contact: Vitor AS Teixeira
• Phone: 918219891
• Email: vitor.as.teixeira[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
Portugal	Hospital de Santa Maria	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Santa Maria, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical and functional evaluation	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)	0, 1, 2, 3 weeks and 6 months