Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: AVACEN Thermal Exchange System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks. | Device: AVACEN Thermal Exchange System<br>* Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.<br>* Other names: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM]);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Widespread Pain Index (WPI) Score After 4 Weeks Treatment | 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. | 4 Weeks | 
| Tender Point Count (TPC) After 4 Weeks Treatment | 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. | 4 Weeks | 
| Symptom Severity (SS) Score After 4 Weeks Treatment | 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 moderate severe: continuous, life-disturbing | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Fibromyalgia, Non-Invasive, Arthritis, Rheumatoid Disease