Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Phase 2CompletedNCT01619579

Avacen, Inc.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

AVACEN Thermal Exchange SystemDEVICE

Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

VA San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 4 Weeks

Data from ClinicalTrials.gov

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