"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Information source: Argentine Tennis Association
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Achilles Tendinopathy
Intervention: etoricoxib (Drug); diclofenac (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Argentine Tennis Association Overall contact:
Javier Maquirriain, MD, Phone: 54 9 11 4478 8367, Email: jmaquirriain@yahoo.com
Summary
The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness
and functional recovery of patients suffering acute Achilles tendinopathy.
It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to
diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles
tendinopathy.
Clinical Details
Official title: "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The pre-defined primary efficacy endpoint of the study is a 100-mm pain visual analog scale (P-VAS), where 0= no pain; 100= extreme pain.
Secondary outcome: The secondary study endpoints includes: the VISA-A Questionnaire, the Achilles Tendinopathy Scoring System (ATSS), PGART using a 5-point Likert scale and leg functional stiffness.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Javier Maquirriain, MD, Phone: 54 9 11 4478 8367, Email: jmaquirriain@yahoo.com
Argentine Tennis Association, Buenos Aires, Argentina
Additional Information
Starting date: January 2009
Ending date: April 2010
Last updated: November 14, 2008
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