Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia

Completed

Conditions studied: Fibromyalgia, Pain

In brief

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.

Key facts

Study ID

NCT01322425

Run by

University of Minnesota

People needed

24

Starts

2010-07-01

Expected to finish

2014-07-01

Last updated by the study team

2014-08-20

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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