FibromyalgiaNCT01322425
Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia
An observational study of Fibromyalgia and Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Pain
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy or patients with fibromylgia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55108
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia, Pain
- Medical subject headings
- Fibromyalgia, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Body temperature was taken over a two hour interval at two different ambient temperatures.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice A. Larson, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322425
- Sponsor's protocol ID
- 1007M85352
- Status last verified
- Aug 2014
- First submitted
- 22 Mar 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urocortins and Musculoskeletal Hyperalgesia
- ClinicalTrials.gov ID
- NCT01322425
- Acronym / sponsor ID
- 1007M85352
- Conditions
- Fibromyalgia, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy or patients with fibromylgia
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body temperature
Time frame: 2 hours
Body temperature was taken over a two hour interval at two different ambient temperatures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice A. Larson, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.