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

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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 Type Interventional
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
Enrollment 22
Recruitment Details The design and the associated protocols were approved by the Institutional Review Boards of the University of California San Diego and the U.S. Department of Veteran Affairs. Pre- and post-treatment evaluations were conducted at the UCSD Pain Medicine Clinic in San Diego, CA.
Pre-assignment Details Participants enrolled were diagnosed with FMS according to the 2010 ACR diagnostic criteria and were advised to refrain from stopping, changing, or starting any new treatment programs other than the study intervention. Patients who recently started, stopped, or changed pain or mood treatment were ineligible to enroll until three months had elapsed.
Arm/Group Title Treatment Group A Treatment Group B
Hide Arm/Group Description Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
Period Title: Overall Study
Started 5 17
Completed 5 14
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             3
Arm/Group Title Treatment Group A Treatment Group B Total
Hide Arm/Group Description Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home. Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home. Total of all reporting groups
Overall Number of Baseline Participants 5 17 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 5 participants 17 participants 22 participants
41
(21 to 62)
52
(31 to 76)
48
(21 to 76)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 17 participants 22 participants
Female
5
 100.0%
15
  88.2%
20
  90.9%
Male
0
   0.0%
2
  11.8%
2
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 17 participants 22 participants
5 17 22
Widespread Pain Index (WPI)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 17 participants 22 participants
15.4
(13 to 18)
15.0
(8 to 19)
15.1
(8 to 19)
[1]
Measure Description:

BASELINE SCORE DESCRIPTION:

Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Full Baseline Range of Group A Results: 13 to 18 points. Full Baseline Range of Group B Results: 8 to 19 points. 15.4 was the Baseline Average WPI Score for Treatment Group A. 15.0 was the Baseline Average WPI Score for Treatment Group B. 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)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 17 participants 22 participants
15.4
(12 to 18)
14.07
(6 to 18)
14.4
(6 to 18)
[1]
Measure Description:

BASELINE SCORE 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. Full Baseline Range of Group A Results: 12 to 18 points. Full Baseline Range of Group B Results: 6 to 18 points. 15.4 was the Baseline Average TPC Score for Group A. 14.07 was the Baseline Average TPC Score for Group B.

Symptom Severity (SS) Score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 5 participants 17 participants 22 participants
9.0
(5 to 12)
9.3
(6 to 12)
9.2
(5 to 12)
[1]
Measure Description:

BASELINE SCORE 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

  1. = slight or mild
  2. = moderate
  3. = severe: continuous, life-disturbing

Full Baseline Range of Group A: 5 to 12 points. Full Baseline Range of Group B: 6 to 12 points. 9.0= Baseline Average for Group A. 9.3= Baseline Average for Group B.

1.Primary Outcome
Title Widespread Pain Index (WPI) Score After 4 Weeks Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.
Arm/Group Title Treatment Group A Treatment Group B
Hide Arm/Group Description:
Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
Overall Number of Participants Analyzed 5 14
Mean (Full Range)
Unit of Measure: units on a scale
13.0
(8 to 17)
8.9
(3 to 18)
2.Primary Outcome
Title Tender Point Count (TPC) After 4 Weeks Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.
Arm/Group Title Treatment Group A Treatment Group B
Hide Arm/Group Description:
Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
Overall Number of Participants Analyzed 5 13
Mean (Full Range)
Unit of Measure: units on a scale
12.6
(6 to 18)
10.0
(2 to 18)
3.Primary Outcome
Title Symptom Severity (SS) Score After 4 Weeks Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.
Arm/Group Title Treatment Group A Treatment Group B
Hide Arm/Group Description:
Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
Overall Number of Participants Analyzed 5 14
Mean (Full Range)
Unit of Measure: units on a scale
8.4
(5 to 11)
7.4
(4 to 11)
Time Frame 4-week data collection period: No adverse events related to use of the ATM device or the ATM warming therapy were reported by any of the participants during the study.
Adverse Event Reporting Description No adverse events related to use of the ATM device or the ATM warming therapy were reported by any of the participants during the study.
 
Arm/Group Title Treatment Group A Treatment Group B
Hide Arm/Group Description Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home. Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
All-Cause Mortality
Treatment Group A Treatment Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treatment Group A Treatment Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group A Treatment Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tobias Moeller-Bertram, MD
Organization: VA Medical Center & UCSD Center for Pain Medicine
Phone: 858-552-8585 ext 3123
EMail: tmoellerbertram@ucsd.edu
Layout table for additonal information
Responsible Party: Avacen, Inc.
ClinicalTrials.gov Identifier: NCT01619579    
Other Study ID Numbers: 110973
First Submitted: June 12, 2012
First Posted: June 14, 2012
Results First Submitted: July 30, 2015
Results First Posted: December 1, 2015
Last Update Posted: February 1, 2017