Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Fibromyalgia Clinical Trial

— AVACEN: TES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619579
• Other study ID #: 110973
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2012
• Last updated: November 30, 2015
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: Avacen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

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.

Locations

Country	Name	City	State
United States	VA San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Avacen, Inc.	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Weeks	No
Primary	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.	4 Weeks	No
Primary	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	4 Weeks	No

External Links

•   Device manufacturer's website
•   Primary Investigator Profile
•   VA San Diego website. Location study is conducted.