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?

Do subjects with symptomatic knee osteoarthritis demonstrate more widespread mechanical and cold hyperalgesia compared with matched controls, and can this hyperalgesia be better modified by a 2-week course of Arcoxia than placebo?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000524291

Enrollment

Registered

2009-07-01

Start date

2009-08-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

etoricoxib 60mg (oral) daily, 14 day intervention

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

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

Outcome results