"AINE en la tendinopatía aquílea aguda: efecto sobre el control del dolor, la rigidez de la pierna y la recuperación funcional en deportistas"

CompletadoFase 4ClinicalTrials.gov

ID: NCT00792376Tipo: INTERVENTIONALInicio: 1 de ago de 2009Fin estimado: 1 de feb de 2012

Resumen

El propósito de este estudio es evaluar la eficacia de etoricoxib en el control del dolor, la rigidez de la pierna y la recuperación funcional de pacientes con tendinopatía aquílea aguda. Se plantea la hipótesis de que la eficacia de etoricoxib (120 mg oral/día/7 días) no es inferior a la de diclofenac (150 mg oral/día/7 días) para el control del dolor en sujetos con tendinopatía aquílea aguda.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 50 YearsSexo: MALE

Criterios de inclusión

Patients are eligible if they are male between 18 and 50 years of age and they suffer acute Achilles tendinopathy (\<2 weeks). Diagnosis of Achilles tendinopathy is made by means of activity-related achillodynia, morning stiffness or pain, painful one-legged jumping test, tenderness and decreased sports performance (26). Subjects' age, race, affected tendon (right, left), activity, height and weight will be recorded.

Criterios de exclusión

Patients are excluded from the study if they have:
Prior lower limb surgery or major trauma.
Bilateral Achilles tendinopathy.
History of lower limb radiculo-neuropathy or miopathy.
Hypersensitivity to any NSAIDs.
Used analgesic agents (NSAIDs, salicilates, narcotic) within 1 week
Concurrent medical/arthritic disease (e.g. gout, lupus, rheumatoid arthritis).
Other concurrent medical conditions including diabetes, hypertension, angina or congestive heart failure, ischaemic cardiopathy, malabsorption, morbid - Personal history of renal dysfunction, hepatic dysfunction or anemia
Used corticosteroids, clopidogrel bisulphate, rifampin, quinolon antibiotics, antiepileptics, muscle relaxants, warfarin, ticlopidine, glucosamine, condroitin sulphate for \< 6 months prior to the study start. Patients taking low dose aspirin (100 mg) for cardioprotective benefit will be also excluded. Any other medication consumption will be considered by the investigator and the Ethical Committee.
Any other condition which, in the opinion of the investigator, could confound the study results or pose a risk to the patient (for example, co-morbid conditions for which NSAIDs are contraindicated).
History of psychotic illness, dementia or depression
History of drug or alcohol abuse or dependence.
Participated in any previous NSAIDs study and received active treatment, or in an investigational trial within 30 days prior to the first visit.
Inability to communicate or to cooperate with the investigator.

Intervenciones

drug

etoricoxib

etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days

drug

diclofenac

diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.

Ubicaciones

Argentine Tennis Association

Buenos Aires, Argentina

Patrocinadores

PrincipalArgentine Tennis Association

ColaboradorMerck Sharp & Dohme LLC

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