EUCTR2021-002784-21-SE进行中（未招募）1 期
Botulinum toxin type A as treatment for chronic myogenous orofacial pain - a radomized controlled, double-blind clinical trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age at least 18years
- •Written consent
- •Adequate communicative skills in Swedish
- •Myalgia as defined by DC/TMD
- •Prior conservative treatment for at least 6months with a minimum of information on diagnosis and prognosis, patient councelling, instruction in resting the jaw, biofeedback training and jaw exercise
- •Subjective degree of pain = 40mm on a 100mm VAS scale
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Pain of dental origin
- •Athritis as defined by DC/TMD expanded taxonomy
- •Rheumatic disease diagnosed by physician (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis / Bechterew's disease, reactive arthritis, juvenile idiopathic arthritis)
- •Neuropathic pain, diagnosed by physician, of central / peripheral genesis or infectious / inflammatory genesis (eg stroke, multiple sclerosis, brain damage, traumatic or surgically triggered facial injury, tumor-induced nerve involvement, postherpetic neuralgia, trigeminal neuralgia, neuroborreliosis
- •Impaired neuromuscular transmission e.g. myasthenia gravis or Eaton Lambert's syndrome or peripheral motor neuropathic and neurological diseases (eg amyotrophic lateral sclerosis or motor neuropathy), diagnosed by physician
- •Hypersensitivety or allergy to any botulinum toxin product or to any of the components in the formulation
- •Pregnancy / breastfeeding or planned pregnancy. Women of childbearing potential must use highly effective contraceptives i.e oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception, oral, injectable or implantablie progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS) 2, bilateral tubal occlusion, vasectomised partner. CE- approved pregnancy tests are handed to the patient for monthly tests up to 6 months after the last injection (a total of 11 tests).
- •Infection at site of injection
- •Ongoing treatment with aminoglycosides, cholinesterase inhibitors or muscle relaxants
- •Prior or ongoing treatment with botulinum toxin A of any serotype
研究者
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