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Mesotherapy In Lateral Epicondylitis (MILES)

Primary Purpose

Lateral Epicondylitis

Status
Unknown status
Phase
Phase 2
Locations
Portugal
Study Type
Interventional
Intervention
Piroxicam, lidocaine
Mesotherapy without drug administration
Sponsored by
Hospital de Santa Maria, Portugal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de Santa MariaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Mesotherapy with piroxicam and lidocaine

Mesotherapy without piroxicam and lidocaine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
December 11, 2019
Last Updated
December 16, 2019
Sponsor
Hospital de Santa Maria, Portugal
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1. Study Identification

Unique Protocol Identification Number
NCT04201249
Brief Title
Mesotherapy In Lateral Epicondylitis
Acronym
MILES
Official Title
MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 12, 2021 (Anticipated)
Study Completion Date
December 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Santa Maria, Portugal

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesotherapy with piroxicam and lidocaine
Arm Type
Active Comparator
Arm Title
Mesotherapy without piroxicam and lidocaine
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Piroxicam, lidocaine
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Mesotherapy without drug administration
Intervention Description
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 Measure Information:
Title
Pain intensity: visual analogue scale score
Description
pain intensity quantified by using a 0-100 visual analogue scale (VAS) score; a higher score means a higher pain intensity on the VAS
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical and functional evaluation
Description
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)
Time Frame
0, 1, 2, 3 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitor AS Teixeira
Phone
918219891
Ext
00351
Email
vitor.as.teixeira@gmail.com
Facility Information:
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vítor AS Teixeira
Phone
918219891
Ext
00351
Email
vitor.as.teixeira@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mesotherapy In Lateral Epicondylitis

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