Original Study Name: Effects of a 4-week AVACEN Treatment on Pain Perception in Fibromyalgia: An Open Label Study
Collaborators: University of California, San Diego, San Diego Veterans Healthcare System
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.
Objectives: To evaluate the efficacy of the AVACEN Treatment Method (ATM) at improving pain symptoms in fibromyalgia patients.
Methods: Twenty female and two male participants (26 to 76 years; M=48 years) diagnosed with fibromyalgia, were randomized into two groups. Group A (n=5) underwent one 10 min therapeutic warming session daily, and Group B (n=17 started, n=14 completed) underwent two 15 min warming sessions daily. The following endpoints were evaluated (a total of 10): widespread pain index (WPI), patient global impression of change, tender point counts (TPC), fibromyalgia impact questionnaire, Beck depression inventory, fatigue severity ratings, cognitive symptom severity, symptom severity score (SS) and weekly pain intensity ratings. Additional unconventional exploratory analysis of HRV and cytokines was performed to observe perception correlations of the participants.
Results: The daily 10 min warming sessions, resulted in a decrease in widespread pain and weekly pain intensity symptoms for the majority of participants in Group A. Increasing the treatment to two 15 min sessions daily demonstrated a pronounced reduction of pain symptoms for the participants in Group B. Data were analyzed with either a paired t-test, or the Wilcoxon signed rank test. The pre- and post-treatment data for Group B indicated a statistically significant reduction (p=0.05) in TPC, WPI, and SS scores. Inspections of HRV and Cytokines found no statistically significant data. No adverse events were reported.
Discussion: These results provide the first indications that the ATM has a statistically significant effect on the key scientifically recognized fibromyalgia diagnosis metrics of WPI, TPC and SS.
Complete Clinical Trial Information from Open Label: Effects of a 4-week AVACEN Treatment on Pain Perception in Fibromyalgia: An Open Label Study