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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin and Placebo | Experimental | Melatonin 10mg and placebo, once in the evening, for 6 weeks. |
|
| Amitriptyline and placebo | Experimental | Amitriptyline 25mg and placebo, once in the evening, for 6 weeks. |
|
| Melatonin and Amitriptylin | Active Comparator | Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin and Placebo | Drug |
| ||
| Amitriptyline and Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 | Baseline, week 6 | |
| Change from Baseline in Pain Pressure Threshold (PPT) at week 6 | Pain Pressure Threshold by Fischer algometer on the tender points. | Baseline, week 6 |
| Change from Baseline Brain-derived neurotrophic factor at week 6 | Baseline, week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Catastrophic thinking related to pain |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolnei Caumo, PhD | Contact | 555133598083 | caumo@cpovo.net |
| Name | Affiliation | Role |
|---|---|---|
| Wolnei d Caumo, PhD | Hospital de Clinicas de Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 900035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25052847 | Derived | de Zanette SA, Vercelino R, Laste G, Rozisky JR, Schwertner A, Machado CB, Xavier F, de Souza IC, Deitos A, Torres IL, Caumo W. Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial. BMC Pharmacol Toxicol. 2014 Jul 23;15:40. doi: 10.1186/2050-6511-15-40. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| Melatonin and Amitriptylin | Drug |
|
| Baseline; week 6 |
| D009422 |
| Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |