NCT01333150Unknown不适用
Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The project's primary purpose is to test the hypothesis that oral administration of a low single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with masticatory muscle pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for myofascial TMD diagnosis corresponding to group 1a or 1b
- •Characteristic Pain Intensity (CPI) more than or equal to 20 (Axe II, RDC/TMD questionnaire)
- •Women of childbearing potential must use adequate contraception
- •Signed consent statement
排除标准
- •Other acute pain cause such as acute toothache or a pain condition the investigator estimates to be contraindicated for participation in the experiment
- •Recognized existing malignancy or within last 5 years
- •Known HIV
- •Abuse of drugs including alcohol
- •Recognized Raynaud's syndrome
- •Former sympathectomy
- •Known cardiovascular disease including abnormal EKG and blood pressure (ECG-12 is recorded before the first trial session and assessed by the physician)
- •Recognized lung insufficience, including bronchial asthma
- •Known severe hepatic or renal dysfunction
- •Known diabetes mellitus
- •Known severe depression
- •Pregnancy (tests performed in both sessions 1 and 2 before the start of a session)
- •Fertility Treatment
- •Lactation
- •Post-menopausal
- •Previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients
- •Patients who can not read and understand the written information
- •Patients who can not follow the protocol
- •Patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc.
研究组 & 干预措施
Propranolol
Experimental
干预措施: Propranololhydrochlorid (Drug)
Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity
时间窗: Participants will be asked to score their actual pain level in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions
Numeric Rating Scale 0-10
次要结局
- Haemodynamic parameters(Participants will be monitored during the entire session in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions)
研究者
研究点 (2)
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