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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.

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 14, 2012
Results First Submitted Date  ICMJE July 30, 2015
Results First Posted Date  ICMJE December 1, 2015
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
Improved Pain Ratings [ Time Frame: 1 month ]
Lower pain ratings after 1 month treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Official Title  ICMJE Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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])
Study Arms  ICMJE Experimental: Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
Intervention: Device: AVACEN Thermal Exchange System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2012)
15
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01619579
Other Study ID Numbers  ICMJE 110973
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avacen, Inc.
Study Sponsor  ICMJE Avacen, Inc.
Collaborators  ICMJE
  • University of California, San Diego
  • San Diego Veterans Healthcare System
Investigators  ICMJE Not Provided
PRS Account Avacen, Inc.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP