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

• 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: Avacen, Inc.
• Collaborators: University of California, San Diego; San Diego Veterans Healthcare System
• Information provided by (Responsible Party): Avacen, Inc.

Tracking Information

• First Submitted Date: June 12, 2012
• First Posted Date: June 14, 2012
• Results First Submitted Date: July 30, 2015
• Results First Posted Date: December 1, 2015
• Last Update Posted Date: February 1, 2017
• Study Start Date: June 2011
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: June 13, 2012)

Improved Pain Ratings [ Time Frame: 1 month ]

Lower pain ratings after 1 month treatment

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fibromyalgia

Intervention

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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2015): 22
• Original Estimated Enrollment (submitted: June 13, 2012): 15
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01619579
• Other Study ID Numbers: 110973
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Avacen, Inc.
• Original Responsible Party: Tobias Moeller-Bertram, University of California, San Diego, Associate Clinical Professor of Anesthesiology
• Current Study Sponsor: Avacen, Inc.
• Original Study Sponsor: University of California, San Diego

Collaborators

• University of California, San Diego
• San Diego Veterans Healthcare System

• Investigators: Not Provided
• PRS Account: Avacen, Inc.
• Verification Date: December 2016