2023-504033-44-00招募中3 期
Botulinumtoxin A as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders – a quality study associated to a new treatment routine.
Region Stockholm Folktandvarden1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年2月5日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Changes in pain and if the dose matters for pain relief is the primary outcome.
研究概览
简要总结
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent
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
- 否
入选标准
- •a) Female gender b) age 18-45 years c) diagnos of myalgia, myofacial pain or myofascial pain with refered pain according to DC/TMD d) an average pain due to NRS ≥ 3 for more than three months e) treatment for orofacial pain > three months ago.f) with adequate contraceptives and a negative pregnancy test. Patients will still be included even if they have one or more co-diagnoses 1) Discdisplacement with or without reduction according to DC/TMD 2) degenerative joint disease 3) arthralgia
排除标准
- •treatment with BTX during the last six months 2) treatment for orofacial pain within the last 3 months. 3) systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) 4) fibromyalgia 5) neuropathic pain 6) neurologic disease (myastenia gravis) 7) pain of dental origin 8) use of muscle relaxants or aminoglycoside antibiotics 9) pregnancy or nursing 10) hypersensitivity to BTX 11) neuropsychiatric conditions.12) difficulties understanding the Swedish language.13) Trauma to head, neck or face, including orthognatic surgery
结局指标
主要结局
Changes in pain and if the dose matters for pain relief is the primary outcome.
Changes in pain and if the dose matters for pain relief is the primary outcome.
次要结局
- Changes in quality of life according to OHIP. Treatment outcome in sub-groups of myogenous TMD. Maximum jaw opening with and without pain between doses and subgroups. The patient´s changes psychosocially, how the jawfunction is affected according to changes in Axis II and changes in PPT.
研究者
clinical trial information desk
Scientific
Region Stockholm Folktandvarden
研究点 (1)
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