Do people with painful knee osteoarthritis have greater pain sensitivity than similar aged healthy people, and can this pain sensitivity be altered by a 2-week course of the anti-inflammatory Arcoxia?

Phase 4

• Conditions: osteoarthritis; chronic pain; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12609000524291
• Lead Sponsor: Curtin University of technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

i) unilateral diagnosis of Knee Osteoarthritis (OA) >6 months
ii) knee pain >4/10 on WOMAC pain subscale
iii) if pain in contralateral knee, no greater than mild
iv) no other significant joint involvement
v) American Rheumatology Association (ARA) functional Class I, II or III
vi) no athroscopy or injections into index knee in last 6 months.

Exclusion Criteria

i) history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)
ii) neurological deficit
iii) recent (<6 months) lower limb surgery
iv) allergic reaction to Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin
v) skin allergies, dermatitis
vi) contraindications to Cox-2 inhibitors: congestive heart failure (New York Heart Association Classifications II-IV); unstable hypertension; ischaemic heart disease, peripheral artery disease, cerebrovascular disease including coronary artery bypass graft or angioplasty within 1 year; severe hepatic dysfunction; active gastro-intestinal tract bleeding or peptic ulceration; reduced creatinine clearance <30mL/min
vii) current use of high dose (>325mg daily) aspirin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure Pain Threshold, assessed using an electronic algometer (Somedic, AB), 1cm square tip, applied at 90 degrees to test site at a rate of 40kPa/sec. Subjects press switch to record pressure when pain is first perceived.[Primary Timepoint: 2 weeks post start of intervention (15th day)<br>Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention];Western Ontario and McMaster University Osteoarthritis Index (knee) (WOMAC) - pain subscale[Primary Timepoint: 2 weeks post start of intervention (15th day)<br>Secondary Timepoint (analysed if Primary Timepoint significant): 2 days post start of intervention]