Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
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|ClinicalTrials.gov Identifier: NCT01619579|
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : December 1, 2015
Last Update Posted : February 1, 2017
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|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|
|Actual Primary Completion Date :||May 2012|
|Actual 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
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Pregnant/Planning to become pregnant
- Major unstable psychiatric illness
- Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||Avacen, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 14, 2012 Key Record Dates|
|Results First Posted:||December 1, 2015|
|Last Update Posted:||February 1, 2017|
|Last Verified:||December 2016|
Myofascial Pain Syndromes
Nervous System Diseases