ACTRN12613000840785尚未招募不适用
A randomized, blinded, comparator-controlled trial investigating a 28-day course of Lyrica in participants with knee osteoarthritis who exhibit neuropathic pain, compared with a 28-day course of acetaminophen.
Dr Robert Will0 个研究点目标入组 90 人开始时间: 2013年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Unilateral diagnosis of knee OA greater than 6 months duration, according to the American College of Rheumatology clinical classification system (diagnosis performed by an experienced Rheumatologist (Dr Will) based on radiological & clinical presentation); Pain in the index knee greater than or equal to 4 out of 10 with an additional 1-1.5 out of 10 increase in pain on walking when withdrawn from their usual analgesic medication; No additional clinically significant joint involvement and otherwise in good health; American Rheumatology Association functional Class I, II or III; No recent arthroscopy, injections with glucocorticoid or hyaluronan in last 6 months to index knee; No plan for joint replacement surgery during the study period.
排除标准
- •History of other systemic inflammatory conditions; neurological deficits (motor, cognitive or sensory); recent lower limb injury or surgery (< 6 months); history of other chronic pain disorders (eg fibromyalgia); skin allergies; history of allergic reaction to pregabalin / gabapentin / acetaminophen; ASA of IV; severe hepatic dysfunction (serum albumin <25g/l); congestive heart failure; chronic renal failure; pregnancy; breast feeding;
- •compromised creatinine clearance (<30mL/min); hereditary
- •problems with galactose metabolism; History of severe depression or currently on medication for depression or anxiety.
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