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OpenTrials
Completed

NCT Number: NCT01619579

Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

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.

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Key information

Conditions

Fibromyalgia Arthritis Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVACEN Thermal Exchange System

Device

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

Other names: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])

Primary outcomes

  1. 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.

  2. 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.

  3. 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
    • moderate
    • severe: continuous, life-disturbing

Sponsors and collaborators

Lead sponsor

Avacen, Inc.

Industry

Collaborators

  • San Diego Veterans Healthcare System
  • University of California, San Diego

Registry information

Official study title

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

Acronym: AVACEN: TES

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 14, 2012
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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