MESOTHERAPY IN LATERAL EPICONDYLITIS, A RANDOMIZED, DOUBLE- BLIND STUDY TO COMPARE THE EFFICACY OF MESOTHERAPY WITH PIROXICAM AND LIDOCAINE VERSUS INTRADERMAL DRY NEEDLING, IN THE TREATMENT OF LATERAL EPICONDYLITIS.

MESOTHERAPY IN LATERAL EPICONDYLITIS, A RANDOMIZED, DOUBLE- BLIND STUDY TO COMPARE THE EFFICACY OF MESOTHERAPY WITH PIROXICAM AND LIDOCAINE VERSUS INTRADERMAL DRY NEEDLING, IN THE TREATMENT OF LATERAL EPICONDYLITIS. - MILES

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006462-20-PT

Enrollment

Registered

2022-07-22

Start date

2022-11-30

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lateral epicondylitis

Interventions

Product Name: Piroxicam Pharmaceutical Form: Solution for injection INN or Proposed INN: PIROXICAM CAS Number: 36322-90-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years with 1) clinical diagnosis of LE defined as pain over the lateral epicondyle provoked by palpation, resisted extension or gripping; 2) A visual analogue scale (VAS) score for pain greater than 40mm (0-100mm); 3) symptoms duration for more than 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1) 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; 2) VAS score for pain less than 40mm; 3) 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; 4) nonsteroidal anti-inflammatory drugs (NSAIDS) taken during the week previous to inclusion; 5) pregnancy; 6) allergy to any of the study drugs; 7) severely immunosuppressed patients; 8) known coagulopathies.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of mesotherapy with intradermal piroxicam and lidocaine delivered in comparison with dry needling for the treatment of lateral epicondylitis (LE).;Secondary Objective: Identify clinical, functional, ultrasonographic and biochemical predictors of treatment success/failure and clinical relapse.;Primary end point(s): Changes from baseline in pain intensity quantified by using a 0-100 VAS score. We will consider the treatment effective if a reduction of 20/100 in the VAS score is achieved.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To assess the efficacy of mesotherapy with intradermal piroxicam and lidocaine delivered in comparison with dry needling for the treatment of lateral epicondylitis (LE).;Secondary Objective: Identify clinical, functional, ultrasonographic and biochemical predictors of treatment success/failure and clinical relapse.;Primary end point(s): Changes from baseline in pain intensity quantified by using a 0-100 VAS score. We will consider the treatment effective if a reduction of 20/100 in the VAS score is achieved.;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): - Changes from baseline in a three-point scale that measures pain on resisted dorsiflexion of the wrist and third finger, registered as none, some or definite, at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. - Changes from baseline in general health evaluation with the short form-36 mental health (SF- 36 MH), at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months - Changes from baseline in frequency of professional and sports activities and sick-leave at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months -Changes from baseline of functional scoring evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE) at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. -Changes from baseline in strength and motion evaluated using the physician assessment section of the ASES-E score (American Shoulder and Elbow Surgeons - Elbow Assessment Form), at 1 week, 2 weeks, 3 weeks, 1 month and 3 months.;Timepoint(s) of evaluation of this end point: 1 week, 2 weeks, 3 weeks, 1 month and 3 months.	—

Measure

Time frame

Secondary end point(s): - Changes from baseline in a three-point scale that measures pain on resisted dorsiflexion of the wrist and third finger, registered as none, some or definite, at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. - Changes from baseline in general health evaluation with the short form-36 mental health (SF- 36 MH), at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months - Changes from baseline in frequency of professional and sports activities and sick-leave at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months -Changes from baseline of functional scoring evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE) at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. -Changes from baseline in strength and motion evaluated using the physician assessment section of the ASES-E score (American Shoulder and Elbow Surgeons - Elbow Assessment Form), at 1 week, 2 weeks, 3 weeks, 1 month and 3 months.;Timepoint(s) of evaluation of this end point: 1 week, 2 weeks, 3 weeks, 1 month and 3 months.

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Countries

Portugal

Contacts

Public ContactAna Lopes

Hospital Santa Maria

ana.f.r.lopes@chln.min-saude.pt

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026