Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)

Avacen

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Device: AVACEN Thermal Exchange System

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01619579

110973

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Treatment

Experimental group

Description:

Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.

Treatment:

Device: AVACEN Thermal Exchange System