Pain Clinical Trial
Official title:
Urocortins and Musculoskeletal Hyperalgesia
The pathophysiology of pain related to fibromyalgia is not understood. This condition is
difficult to diagnose and to treat. One clue may be that tender points (areas which hurt
typical of fibromyalgia) are most densely located near the clavicles. This is also the area
where brown fat is located in humans. Brown fat is typically used to maintain body
temperature. Stress (such as cool temperature or special diets, i.e., high fat, low
carbohydrate) appears to worsen the pain seen in fibromyalgia. We hypothesize that a
mechanism for pain in this disease relates to activating brown fat through neural
mechanisms. The nerves to brown fat also go into adjacent muscle and skin. So, when brown
fat is turned on or increases in amount, collateral nerves may cause pain at the tender
points.
The central hypothesis is that stress such as temperature or diet will activate brown fat.
Patients with fibromyalgia will have greater activation or volume of brown fat. Neuralgia
related to stress may be the etiology of the pain. If this hypothesis is proven, there are
several drugs on the market that could be deployed to correct these patients' problems.
Therefore, this project, if successful, will lead to clinical trials of these drugs in
fibromyalgia patients.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Female - 18-50 years of age and premenopausal fibromyalgia or 30-50 years of age and premenopausal for healthy volunteers - Healthy volunteer or diagnosis of fibromyalgia - In follicular phase (Days 1-12) of menstrual cycle OR on contraceptives. - Able to comply with study procedures. - Capable of giving informed consent; consent obtained and form signed Exclusion Criteria: - Serious medical conditions (determined by investigator) - Some medicines that affect brain metabolism (determined by investigator) - Subjects who have participated in other studies with radioactivity may not be eligible depending on prior exposure - BMI more than 35 kg/m2 (i.e. severe obesity) - Pregnant or nursing females - Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body temperature | Body temperature was taken over a two hour interval at two different ambient temperatures. | 2 hours | No |
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