Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis

Study Overview
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Brief Summary
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This study aims to better understand the way in which painful osteoarthritis affects different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can help to modify this pain. The study will use questionnaires and tests of pain sensitivity to identify arthritis sufferers with more widespread, nerve-type pain and then to investigate whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these symptoms and improving functional movements. The study will also be comparing the same test results of a small group of subjects without knee pain.

Official Title
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A Randomised Placebo-controlled Trail of Mechanical and Cold Hyperalgesia in Subjects With Painful Knee Osteoarthritis, Compared With Matched Controls, & Whether This Hyperalgesia Can be Modified by a 2-week Course of Etoricoxib 60mg.

Conditions
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Osteoarthritis, Pain

Intervention / Treatment
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* Drug: Etoricoxib (Arcoxia)
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral diagnosis of Knee OA > 6 months knee pain > 4/10 on WOMAC pain subscale if pain in contralateral knee, no greater than mild no other significant joint involvement ARA functional Class I, II or III no arthroscopy or injections into index knee in last 6 months Exclusion Criteria: history of systemic inflammatory or chronic pain disorders (especially fibromyalgia) neurological deficit recent (< 6 months) lower limb surgery allergic reaction to NSAIDs or aspirin skin allergies, dermatitis contraindications to Cox-2 inhibitors: congestive heart failure (NYHA II-IV) unstable hypertension ischaemic heart disease peripheral artery disease cerebrovascular disease including CABG or angioplasty within 1 year severe hepatic dysfunction active GI bleeding or peptic ulceration reduced creatinine clearance < 30 mL/min current use of high dose (> 325 mg daily) aspirin

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib 60 mg<br> | Drug: Etoricoxib (Arcoxia)<br>* 60 mg, daily dose, oral delivery, 14 days duration<br>* Other names: Arcoxia;|
| Placebo Comparator: Sugar pill<br> | Drug: Sugar pill<br>* Daily dose (1 pill), oral delivery, 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold |  | 15 days, 3 days | 
| Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale |  | 15 days, 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold Pain Threshold |  | 15 days, 3 days | 
| Topical Cold Response |  | 15 days, 3 days | 
| Functional Measure (aggregated locomotor score, sit-to-stand time) |  | 15 days, 3 days | 
| WOMAC (knee) total |  | 15 days, 3 days | 
| SF-36v2 |  | 15 days, 3 days | 
| Pain Quality Assessment Scale |  | 15 days, 3 days | 
| PainDETECT questionnaire |  | 15 days, 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical hyperalgesia, cold hyperalgesia, chronic pain