Fibromyalgia
Conditions
Keywords
salmon calcitonin, endorphins, treatment, fibromyalgia
Brief summary
The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.
Detailed description
Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. Fibromyalgia occurs in around 2% of the US general population, is more common in women and is associated with substantial morbidity and disability. Treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature. Pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role. Some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. Increasing endorphins levels may decrease pain. Then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia.
Interventions
daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
DRUGintranasal saline solution plus glycerol
daily intranasal (one shot) saline solution plus glycerol for a period of 14 days
Sponsors
Unidad de Investigacion en Enfermedades Cronico-Degenerativas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Female patients between 18 and 50 years * Fibromyalgia diagnosis (ACR criteria) * Must be able to apply the nasal medication * Must be able to comply with study visits * Must be able to understand informed consent * Must be able to answer self-administered questionnaires * Must have an active disease(VAS \> 60mm)
Exclusion criteria
* Comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.) * Any disturbance in the nasal tissue * Use of concomitant opioid analgesics * Contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia) * Other rheumatic diseases * Diagnosis of major depressive disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia | Day 0, Day 14, Day 28 and Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used | Day 0, Day 14, Day 28 and Day 56 |
Countries
Mexico
Outcome results
None listed