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NCT01322425 · ClinicalTrials.gov registry record
Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia
A clinical trial of Pain and Fibromyalgia, sponsored by University of Minnesota.
- Completed
- Registry status
- 24
- Enrollment target
- 1
- Study location
NCT01322425: Completed study of Pain and Fibromyalgia, sponsored by University of Minnesota.
NCT01322425 is a study of Pain and Fibromyalgia that has completed, run by University of Minnesota. The registered enrollment target is 24 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01322425, a study of Pain and Fibromyalgia, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Body temperature was taken over a two hour interval at two different ambient temperatures.
Conditions Studied
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-07 |
What the finished NCT01322425 record still lists
NCT01322425 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 0 interventions.
NCT01322425 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01322425 about?
NCT01322425 is a clinical study titled "Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia". 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 ...
What is the current status of trial NCT01322425?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2010-07. Estimated completion is 2014-07.
What conditions does trial NCT01322425 study?
This clinical trial studies the following conditions: Pain, Fibromyalgia.
Who is sponsoring clinical trial NCT01322425?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01322425 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01322425's enrollment target sits among peer trials
24 325th of 374 higher than 42 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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