Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
研究概览
简要总结
Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .
Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .
The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.
The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-65 years old
- •Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe 2010)
- •Sign the informed consent
- •Patients can take medication for chronic pain ( antidepressants , antiepileptics, for example), since there are at least two months
- •Exclusion criteria:
- •patients who did not understand the Portuguese
- •diagnosis of malignancies, severe psychiatric disorders , sleep disorders not related to fibromyalgia (apnea , sleepwalking , restless leg syndrome), Alzheimer's disease or any disease (rheumatologic, neurological, etc.) that can modify the evaluations or outcomes
- •alcohol abuse or drug addiction
- •patients who are performing acupuncture
- •BMI greater than 35 ( BMI = body mass index) .
- •Patients with history of allergy to amitriptyline or/and melatonin or any other contraindication for the use of these drugs
排除标准
- 未提供
研究组 & 干预措施
Melatonin and Placebo
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
干预措施: Melatonin and Placebo (Drug)
Amitriptyline and placebo
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
干预措施: Amitriptyline and Placebo (Drug)
Melatonin and Amitriptylin
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
干预措施: Melatonin and Amitriptylin (Drug)
结局指标
主要结局
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
时间窗: Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
时间窗: Baseline, week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Change from Baseline Brain-derived neurotrophic factor at week 6
时间窗: Baseline, week 6
次要结局
- Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6(Baseline, week 6)
- Change from Baseline of the Pain Catastrophizing Scale at week 6(Baseline; week 6)