search
Back to results

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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AVACEN Thermal Exchange System
Sponsored by
Avacen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Non-Invasive, Arthritis, Rheumatoid Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.

Outcomes

Primary Outcome Measures

Widespread Pain Index (WPI) Score After 4 Weeks Treatment
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
December 5, 2016
Sponsor
Avacen, Inc.
Collaborators
University of California, San Diego, San Diego Veterans Healthcare System
search

1. Study Identification

Unique Protocol Identification Number
NCT01619579
Brief Title
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Acronym
AVACEN: TES
Official Title
Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avacen, Inc.
Collaborators
University of California, San Diego, San Diego Veterans Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain, Non-Invasive, Arthritis, Rheumatoid Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
Intervention Type
Device
Intervention Name(s)
AVACEN Thermal Exchange System
Other Intervention Name(s)
AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])
Intervention Description
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Primary Outcome Measure Information:
Title
Widespread Pain Index (WPI) Score After 4 Weeks Treatment
Description
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.
Time Frame
4 Weeks
Title
Tender Point Count (TPC) After 4 Weeks Treatment
Description
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.
Time Frame
4 Weeks
Title
Symptom Severity (SS) Score After 4 Weeks Treatment
Description
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
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
VA San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.avacen.com
Description
Device manufacturer's website
URL
http://www.sandiego.va.gov/
Description
VA San Diego website. Location study is conducted.

Learn more about this trial

Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

We'll reach out to this number within 24 hrs