TCTR20210811001招募中3 期
A Comparative Study of 2 doses of Botulinum Toxin A in Post Traumatic Trigeminal Neuropathic Pain
euroscience Research and Development Group, Khon Kaen University0 个研究点目标入组 46 人开始时间: 2021年8月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Diagnosed with PPTTN according to the diagnostic criteria of International Classification of Orofacial Pain (ICOP, 2020)
- •2. Age of 20 to 65 years old
- •3. Pain located intraorally, occurring unilaterally at the side of injury and is located at trigeminal nerve division of V2 and V3.
- •4. Patients experiencing pain score of more than or equal to 4 as measured by the Visual Analogue Scale (VAS) with continuous daily pain and those who do not respond to conventional pharmacotherapy within 3 months of treatment or has developed intolerable adverse reaction or detrimental systemic effects from medication
- •5. Presence of other neuropathic symptoms such as allodynia and numbness are included.
- •6. Participants are required to be in good general health
- •7.Participants who can read, write and have understood the information regarding about the trial and the possible complications.
排除标准
- •1. Women who are pregnant or planning to be pregnant during the trial
- •2. The presence of other orofacial neuropathic conditions (e.g. Trigeminal neuralgia, Post herpetic neuralgia, etc) and headache.
- •3. Patients undergoing alternative treatment for PTTNP (e.g. acupuncture or herbal medicine)
- •4. Patients who have presence of infection at the injection site
- •5. Presence of medical conditions (e.g.motor neuropathic diseases and neuromuscular disorder) or use of any agent that might put patients at increased risk such as severe dysphagia and respiratory difficulties if exposed to BTX-A
- •6. Patients taking substances that might interfere with neuromuscular function
- •7. Having uncontrolled systemic condition such as those who suffer from coagulopathy or severe heart, liver, kidney, or other organ dysfunction
- •8. Patients with unstable mental illness and impaired cognitive.
研究者
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