2024-514739-12-00招募中2 期
Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
Karolinska Institutet, Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月20日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle
研究概览
简要总结
To investigate if treatment with BTX alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle of patients with TMDM
研究设计
- 分配方式
- Randomized
- 主要目的
- Pr1
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I
- •Female aged 20 – 45 years
- •A characteristic pain intensity of > 40/100
- •Pain upon digital palpation of at least one of the masseter muscles
排除标准
- •Difficulties understanding the Swedish language
- •Known allergy to botulinum toxin or antibiotics
- •Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs
- •Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy
- •Previous treatment with BTX during the last 12 months
- •Infection at the injection site
- •Systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) c) widespread pain (e.g. fibromyalgia)
- •Widespread pain (e.g. fibromyalgia)
- •Neuromuscular disorders (e.g. craniomandibular dystonia, myasthenia gravis)
- •Diagnosed or severe psychiatric disease (e.g. schizophrenia, bipolar disorder)
- •Neuropathic pain
- •Pain of dental origin
- •History of trauma to the face, head or neck (incl. orthognathic surgery)
- •Pregnancy or nursing
研究组 & 干预措施
-
Active Comparator
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
The change of gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle
The change of gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle
次要结局
- The change of jaw muscle pain intensity after treatment
研究者
Malin Ernberg
Scientific
Karolinska Institutet
研究点 (1)
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