Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01322425
First received: March 22, 2011
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition
Fibromyalgia
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Urocortins and Musculoskeletal Hyperalgesia

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

The initial study phase will involve five subjects - one healthy volunteer and four women with fibromyalgia. These five subjects will each have one visit that will include several hours in both the warm room and the cold room. Nociceptive flexion reflex (NFR) testing will be conducted while they are in each of the temperature-controlled rooms. We anticipate conducting the initial phase in the last two weeks of November 2010.

The main study project will entail three visits for each of 20 subjects (10 healthy control subjects and 10 women with fibromyalgia. No treatments are planned for this project.

Procedures include: a) screening interview, diagnostic interview, analog rating scales, and psychological and psychiatric rating scales; b) review of medical records if the diagnosis of fibromyalgia is not certain; c) pain will be measured by palpation at tender points and by measurement of biceps reflex that objectively measures amount of pain both before and after visits, d) Visit A will include a special diet for breakfast at 8 AM and resting at room temperature for 2.5 hours (both known to turn off brown fat) before receiving FDG (radioactive sugar) and a PET/CT scan to measure metabolism e) Visit B requires another diet and resting for 2.5 hours at ~62°F (both known to turn on brown fat) along with the PET/CT scan to measure metabolism and a structural MRI to examine brain structure and to measure volume of brown fat in chest; f) blood samples will be collected to measure stress hormones before and after each warm or cold period; g) pregnancy testing before PET/CT and MRI.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy or patients with fibromylgia

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322425

Contacts
Contact: Robert C. Larson, B.S. 612-716-1398 fms@umn.edu
Contact: Alice A. Larson, Ph.D. 612-624-3650 larso011@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55108
Contact: Robert C. Larson, B.S.    612-716-1398    fms@umn.edu   
Principal Investigator: Alice A. Larson, Ph.D.         
Principal Investigator: Jose V. Pardo, M.D., Ph.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Alice A. Larson, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01322425     History of Changes
Other Study ID Numbers: 1007M85352
Study First Received: March 22, 2011
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014