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Mesotherapy In Lateral Epicondylitis

NCT ID: NCT04201249

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-12

Brief Summary

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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

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Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Mesotherapy with piroxicam and lidocaine

Group Type ACTIVE_COMPARATOR

Piroxicam, lidocaine

Intervention Type 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 without piroxicam and lidocaine

Group Type SHAM_COMPARATOR

Mesotherapy without drug administration

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Santa Maria, Portugal

OTHER

Sponsor Role lead

Responsible Party

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Vítor Teixeira

Vitor Teixeira

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Santa Maria

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Vitor AS Teixeira

Role: CONTACT

Phone: 918219891

Email: [email protected]

Facility Contacts

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Vítor AS Teixeira

Role: primary

Other Identifiers

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MILES

Identifier Type: -

Identifier Source: org_study_id