Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study|
- Widespread Pain Index (WPI) Score After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.
- Tender Point Count (TPC) After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.
Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points.
- Symptom Severity (SS) Score After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).
The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:
0 = no problem
- slight or mild
- severe: continuous, life-disturbing
|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.
Other Name: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619579
|United States, California|
|VA San Diego|
|La Jolla, California, United States, 92093|