"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00792376
• Date of registration: 14/11/2008
• Prospective Registration: Yes
• Primary sponsor: Argentine Tennis Association
• Public title: "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
• Scientific title: "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
• Date of first enrolment: August 2009
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00792376
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Argentina

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Achilles Tendinopathy

Intervention(s)

Drug: diclofenac

Drug: etoricoxib

Primary Outcome(s)

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. [Time Frame: 1 week]

Secondary Outcome(s)

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. [Time Frame: 1 week]

Secondary ID(s)

00045-2008

1-47-12225-05-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.