ACTRN12614000683639已完成2 期
A randomised placebo controlled trial of nortriptyline for pain in knee osteoarthritis
Dr Ben Hudson0 个研究点目标入组 200 人开始时间: 2014年6月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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
- •1. Primary knee OA defined according to American College of Rheumatology (ACR) classification criteria (knee pain plus 3 of: age >50 years, stiffness <30 mins, crepitus, bony tenderness, bony enlargement, no palpable warmth).
- •2. Pain severity of >=20 points on the Western Ontario and McMaster Universities (WOMAC) numerical rating scale (range 0 to 50 points) at the study knee.
排除标准
- •01. Prior joint replacement surgery on the study knee
- •02. Intra-articular steroid injection within the previous 3 months
- •03. Secondary OA (OA due to inflammatory arthritis [eg gout, rheumatoid arthritis, juvenile arthritis], septic arthritis or trauma)
- •04. Known hypersensitivity to nortriptyline or history of adverse reaction to any tricyclic antidepressant
- •05. Current use of nortriptyline or other antidepressants, or amiodarone
- •06. Within 6 months of myocardial infarction
- •07. Heart block
- •08. Postural hypotension
- •09. Pregnancy
- •10. Hyperthyroidism or phaeochromocytoma under current investigation or treatment
- •11. History of epilepsy or other seizure
- •12. History of bipolar disorder or manic episode
- •13. History of increased intra-ocular pressure or history of angle-closure glaucoma
- •14. Chronic constipation
- •15. Urinary retention
研究者
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