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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Drug: etoricoxib; Drug: diclofenac

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Argentine Tennis Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etoricoxib; etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days	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.
Active Comparator: diclofenac; diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.	Drug: diclofenac; diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: Argentine Tennis Association
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 14, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: pain; stiffness; NSAID; Achilles; tendon
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Etoricoxib
• Other Study ID Numbers: 00045-2008; 1-47-12225-05-1