Trial Outcomes & Findings for Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain (NCT NCT01619579)

NCT ID: NCT01619579

Last Updated: 2017-02-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 4 Weeks
• Results posted on: 2017-02-01

Participant Flow

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.

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.

Participant milestones

Measure	Treatment Group A Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.	Treatment Group B Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
Overall Study STARTED	5	17
Overall Study COMPLETED	5	14
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Treatment Group A Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.	Treatment Group B Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Baseline characteristics by cohort

Measure	Treatment Group A n=5 Participants 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 Participants 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 n=22 Participants Total of all reporting groups
Age, Customized Age	41 years n=5 Participants	52 years n=7 Participants	48 years n=5 Participants
Gender Female	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	17 participants n=7 Participants	22 participants n=5 Participants
Widespread Pain Index (WPI)	15.4 units on a scale n=5 Participants	15.0 units on a scale n=7 Participants	15.1 units on a scale n=5 Participants
Tender Point Count (TPC)	15.4 units on a scale n=5 Participants	14.07 units on a scale n=7 Participants	14.4 units on a scale n=5 Participants
Symptom Severity (SS) Score	9.0 units on a scale n=5 Participants	9.3 units on a scale n=7 Participants	9.2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: 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.

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.

Outcome measures

Measure	Treatment Group A n=5 Participants 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=14 Participants 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.
Widespread Pain Index (WPI) Score After 4 Weeks Treatment	13.0 units on a scale Interval 8.0 to 17.0	8.9 units on a scale Interval 3.0 to 18.0

PRIMARY outcome

Timeframe: 4 Weeks

Population: 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.

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.

Outcome measures

Measure	Treatment Group A n=5 Participants 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=13 Participants 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.
Tender Point Count (TPC) After 4 Weeks Treatment	12.6 units on a scale Interval 6.0 to 18.0	10.0 units on a scale Interval 2.0 to 18.0

PRIMARY outcome

Timeframe: 4 Weeks

Population: 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.

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

Outcome measures

Measure	Treatment Group A n=5 Participants 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=14 Participants 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.
Symptom Severity (SS) Score After 4 Weeks Treatment	8.4 units on a scale Interval 5.0 to 11.0	7.4 units on a scale Interval 4.0 to 11.0

Adverse Events

Treatment Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tobias Moeller-Bertram, MD

VA Medical Center & UCSD Center for Pain Medicine

Phone: 858-552-8585

Email: tmoellerbertram@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60