We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01619579
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : December 1, 2015
Last Update Posted : February 1, 2017
Sponsor:
Collaborators:
University of California, San Diego
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Avacen, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Device: AVACEN Thermal Exchange System Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
Study Start Date : June 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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])


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619579


Locations
Layout table for location information
United States, California
VA San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Avacen, Inc.
University of California, San Diego
San Diego Veterans Healthcare System
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Avacen, Inc.
ClinicalTrials.gov Identifier: NCT01619579    
Other Study ID Numbers: 110973
First Posted: June 14, 2012    Key Record Dates
Results First Posted: December 1, 2015
Last Update Posted: February 1, 2017
Last Verified: December 2016
Keywords provided by Avacen, Inc.:
Fibromyalgia
Pain
Non-Invasive
Arthritis
Rheumatoid Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases