Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
- Registration Number
- NCT00927004
- Lead Sponsor
- Curtin University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugar pill Sugar pill - Etoricoxib 60 mg Etoricoxib (Arcoxia) -
- Primary Outcome Measures
Name Time Method Pressure Pain Threshold 15 days, 3 days Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale 15 days, 3 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia