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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Etoricoxib 60 mg
干预措施: Etoricoxib (Arcoxia) (Drug)
Sugar pill
干预措施: Sugar pill (Drug)
结局指标
主要结局
Pressure Pain Threshold
时间窗: 15 days, 3 days
Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale
时间窗: 15 days, 3 days
次要结局
- 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)