ACTRN12622000111774尚未招募未知
Evaluation of a novel topical gel for hand osteoarthritis pain: An exploratory trial
niversity of Canberra0 个研究点目标入组 60 人开始时间: 2022年1月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
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. Adults of any age over 18 years.
- •2. Have been diagnosed with hand osteoarthritis
- •3. Have at least two inter/distal phalangeal and/or one first carpometacarpal joint pain
- •4. Have at least two or three painful flare-ups of pain in a finger joint during the previous 12 months
- •5. Discontinuation of all analgesic (prescription or over the counter) at least 3 days prior to first application.
- •6. Able and willing to provide informed consent
排除标准
- •1.Allergies to NSAIDs or any of either of the gel’s ingredients
- •2.Inflamed or broken skin in area to be treated
- •3.Signs or symptoms of systemic infection (such as fever, and chills, nausea and vomiting, blotchy or discoloured skin, weakness, or diarrhoea) as this is not indicated for local osteoarthritis pain
- •4.Systemic conditions (i.e. rheumatoid arthritis, Buerger’s disease, mucous cyst, dactylitis, pyogenic granuloma) and/or taking anti-rheumatic drugs (i.e. methotrexate, cyclosporine)
- •5.Autoimmune diseases: lupus, multiple sclerosis
- •6.Have chronic kidney disease/acute kidney injury
- •7.Use of non-prescription topical or oral analgesic treatment within the last 48 hours
- •8.Current use of a prescription topical or oral analgesic treatment and unable to stop this for the duration of the trial
- •9. History of stomach ulcers
- •10. Asthma
- •11. Anticoagulation/antithrombotic therapies such as aspirin and warfarin
- •12. Antidepressant therapies such as Sertraline (Zoloft), citalopram, fluoxetine and paroxetine
- •13. Taking blood pressure medications
- •14. Acute injury or trauma to either hand in the previous 2 months
- •15. Anyone with loss of sensation in their hands
- •16. Pregnancy
- •17. Scheduled surgery within 2 weeks as there may be a low risk for post-operative bleeding.
研究者
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