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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Avacen, Inc.
ClinicalTrials.gov Identifier:
NCT01619579
First received: June 12, 2012
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

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

Resource links provided by NLM:


Further study details as provided by Avacen, Inc.:

Primary Outcome Measures:
  • Widespread Pain Index (WPI) Score After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Tender Point Count (TPC) After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    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.


  • Symptom Severity (SS) Score After 4 Weeks Treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    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


Enrollment: 22
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.
Other Name: AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Avacen, Inc.
University of California, San Diego
  More Information

Additional Information:
Responsible Party: Avacen, Inc.
ClinicalTrials.gov Identifier: NCT01619579     History of Changes
Other Study ID Numbers: 110973 
Study First Received: June 12, 2012
Results First Received: July 30, 2015
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Avacen, Inc.:
Fibromyalgia
Pain
Non-Invasive
Arthritis
Rheumatoid Disease

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 December 09, 2016