Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
|ClinicalTrials.gov Identifier: NCT01619579|
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : December 1, 2015
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: AVACEN Thermal Exchange System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study|
|Study Start Date :||June 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2013|
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])
- Widespread Pain Index (WPI) Score After 4 Weeks Treatment [ Time Frame: 4 Weeks ]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 ]
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 ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619579
|United States, California|
|VA San Diego|
|La Jolla, California, United States, 92093|