Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Completed · Phase 2

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01619579

Run by

Avacen, Inc.

People needed

22

Starts

2011-06-01

Expected to finish

2013-05-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant/Planning to become pregnant
• Major unstable psychiatric illness
• Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months

Where it is running

• VA San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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