Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | May 2013 |
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.
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
months
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