Piroxicam for Lateral epicondylitis

Inclusion criteria

• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- 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, intraarticular 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pain intensity measured by 0-100 Visual Analogue Scale (VAS); treatment considered effective if reduction of 20/100 in VAS score is achieved."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Three-point pain scale on resisted dorsiflexion (none/some/definite) measured at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. General health evaluated using SF-36 mental health domain at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months."}

Portugal

Earliest CTIS Part Ii Submission Date

07-01-2025

Latest Decision Or Authorization Date

09-01-2025

Processing Time Days

2

Number Of Sites

1

Number Of Participants

85

Primary sponsor

Full Name

Unidade Local De Saude De Santa Maria E.P.E.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Portugal

Co-sponsors

• Instituto De Medicina Molecular Joao Lobo Antunes