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.

• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Treatment Group A	Treatment Group B	Total
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
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; = slight or mild; = moderate; = 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.

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	Treatment Group A	Treatment Group B
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/5 (0.00%)	0/17 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• 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

• 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