Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:18 - 99
Start Date:June 2011
End Date:May 2013

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Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study

Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved
Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and
psychological assessment. This non-invasive device is able to rapidly raise the core body
temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating
element. The change in body temperature may change the sympathetic nervous system's activity
and thereby reduce Fibromyalgia pain.

Inclusion Criteria:

- Fibromyalgia diagnosis

- Over the age of 18

- Understands English

- Not pregnant/planning to become pregnant

- Average pain of 4 or greater over the last week (10 point scale)

- Fibromyalgia pain lasting longer than 6 months

Exclusion Criteria:

- Pregnant/Planning to become pregnant

- Major unstable psychiatric illness

- Major, uncontrolled systemic illness for which you may be hospitalized in the next 6
We found this trial at
La Jolla, California 92093
La Jolla, CA
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