Fibromyalgia
Conditions
Keywords
Fibromyalgia, Pain, Non-Invasive, Arthritis, Rheumatoid Disease
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.
Interventions
DEVICEAVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Sponsors
University of California, San Diego
San Diego Veterans Healthcare System
Avacen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Widespread Pain Index (WPI) Score After 4 Weeks Treatment | 4 Weeks | 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 | 4 Weeks | 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 | 4 Weeks | 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group A 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. | 5 |
| Treatment Group B 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. | 17 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Treatment Group B | Treatment Group A | Total |
|---|---|---|---|
| Age, Customized Age | 52 years | 41 years | 48 years |
| Gender Female | 15 Participants | 5 Participants | 20 Participants |
| Gender Male | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 17 participants | 5 participants | 22 participants |
| Symptom Severity (SS) Score | 9.3 units on a scale | 9.0 units on a scale | 9.2 units on a scale |
| Tender Point Count (TPC) | 14.07 units on a scale | 15.4 units on a scale | 14.4 units on a scale |
| Widespread Pain Index (WPI) | 15.0 units on a scale | 15.4 units on a scale | 15.1 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 17 |
| serious Total, serious adverse events | 0 / 5 | 0 / 17 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group A | Symptom Severity (SS) Score After 4 Weeks Treatment | 8.4 units on a scale |
| Treatment Group B | Symptom Severity (SS) Score After 4 Weeks Treatment | 7.4 units on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group A | Tender Point Count (TPC) After 4 Weeks Treatment | 12.6 units on a scale |
| Treatment Group B | Tender Point Count (TPC) After 4 Weeks Treatment | 10.0 units on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group A | Widespread Pain Index (WPI) Score After 4 Weeks Treatment | 13.0 units on a scale |
| Treatment Group B | Widespread Pain Index (WPI) Score After 4 Weeks Treatment | 8.9 units on a scale |