Investigation of Avacen Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 1 month 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AVACEN for Fibromyalgia: Altering Core Body Temperature to Relieve Pain- An Open Label Study|
- Improved Pain Ratings [ Time Frame: 1 month ] [ Designated as safety issue: No ]Lower pain ratings after 1 month treatment
|Study Start Date:||June 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
Device: AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.