Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Melatonin and Placebo
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
Intervention: Melatonin and Placebo (Drug)
Amitriptyline and placebo
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
Intervention: Amitriptyline and Placebo (Drug)
Melatonin and Amitriptylin
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
Intervention: Melatonin and Amitriptylin (Drug)
Outcomes
Primary Outcomes
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Time Frame: Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Time Frame: Baseline, week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Change from Baseline Brain-derived neurotrophic factor at week 6
Time Frame: Baseline, week 6
Secondary Outcomes
- 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)