Clinical trial NCT00927004: Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Pain
Keywords: mechanical hyperalgesia
cold hyperalgesia
chronic pain
Lead sponsor: Curtin University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: 15 days, 3 days
measure: Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale
timeFrame: 15 days, 3 days
Secondary outcomes:
measure: Cold Pain Threshold
timeFrame: 15 days, 3 days
measure: Topical Cold Response
timeFrame: 15 days, 3 days
measure: Functional Measure (aggregated locomotor score, sit-to-stand time)
timeFrame: 15 days, 3 days
measure: WOMAC (knee) total
timeFrame: 15 days, 3 days
measure: SF-36v2
timeFrame: 15 days, 3 days
measure: Pain Quality Assessment Scale
timeFrame: 15 days, 3 days
measure: PainDETECT questionnaire
timeFrame: 15 days, 3 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: Curtin University
name: Tony Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moss P, Benson HAE, Will R, Wright A. Fourteen days of etoricoxib 60 mg improves pain, hyperalgesia and physical function in individuals with knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2017 Nov;25(11):1781-1791. doi: 10.1016/j.joca.2017.07.009. Epub 2017 Aug 2.