Mesotherapy In Lateral Epicondylitis

Phase 2

• Conditions: Lateral Epicondylitis
• Interventions: Device: Mesotherapy without drug administration; Drug: Piroxicam, lidocaine

• Registration Number: NCT04201249
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-18
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mesotherapy without piroxicam and lidocaine	Mesotherapy without drug administration	-
Mesotherapy with piroxicam and lidocaine	Piroxicam, lidocaine	-

Primary Outcome Measures

Name	Time	Method
Pain intensity: visual analogue scale score	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

Name	Time	Method
Clinical and functional evaluation	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)

Trial Locations

Locations (1)

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal