Immune-Pineal Axis Function in Fibromyalgia
Recruitment status was Recruiting
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.
Drug: Melatonin and Placebo
Drug: Amitriptyline and Placebo
Drug: Melatonin and Amitriptylin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects|
- Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
- Change from Baseline in Pain Pressure Threshold (PPT) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
- Change from Baseline of the Pain Catastrophizing Scale at week 6 [ Time Frame: Baseline; week 6 ] [ Designated as safety issue: No ]Catastrophic thinking related to pain
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Melatonin and Placebo
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
|Drug: Melatonin and Placebo|
Experimental: Amitriptyline and placebo
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
|Drug: Amitriptyline and Placebo|
Active Comparator: Melatonin and Amitriptylin
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
|Drug: Melatonin and Amitriptylin|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02041455
|Contact: Wolnei Caumo, PhDfirstname.lastname@example.org|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 900035-903|
|Contact: Simone de Azevedo Zanette, MD 555133598430|
|Principal Investigator: Wolnei Caumo, PhD|
|Study Director:||Wolnei d Caumo, PhD||Hospital de Clinicas de Porto Alegre|