Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia

NCT01322425 | Completed

• 1 other identifier: 1007M85352
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (1)

• Body temperature

  Body temperature was taken over a two hour interval at two different ambient temperatures.

  2 hours

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy or patients with fibromylgia

You may qualify if:

• Female
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice A. Larson, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (1)