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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tobias Moeller-Bertram, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01619579
First received: June 12, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

Hypothesis: Daily use of the AVACEN Thermal Exchange System for 1 month 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.


Condition Intervention Phase
Fibromyalgia
Device: AVACEN Thermal Exchange System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AVACEN for Fibromyalgia: Altering Core Body Temperature to Relieve Pain- An Open Label Study

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Improved Pain Ratings [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Lower pain ratings after 1 month treatment


Enrollment: 21
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
Device: AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia diagnosis
  • Over the age of 18
  • Understands English
  • Not pregrant/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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619579

Locations
United States, California
VA San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Tobias Moeller-Bertram, Associate Clinical Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01619579     History of Changes
Other Study ID Numbers: 110973
Study First Received: June 12, 2012
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Fibromyalgia
Pain
Non-Invasive

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014