Phase 2
Completed N=22
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Source: ClinicalTrials.gov NCT01619579 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Widespread Pain Index (WPI) Score After 4 Weeks Treatment — 13.0; 8.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Widespread Pain Index (WPI) Score After 4 Weeks Treatment |
13.0; 8.9 | — |
| PRIMARY Tender Point Count (TPC) After 4 Weeks Treatment |
12.6; 10.0 | — |
| PRIMARY Symptom Severity (SS) Score After 4 Weeks Treatment |
8.4; 7.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01619579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.