Investigation of Avacen Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
This study is currently recruiting participants.
Verified June 2012 by University of California, San Diego
Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Tobias Moeller-Bertram, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01619579
First received: June 12, 2012
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 1 month 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Device: AVACEN Thermal Exchange System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | AVACEN for Fibromyalgia: Altering Core Body Temperature to Relieve Pain- An Open Label Study |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Improved Pain Ratings [ Time Frame: 1 month ] [ Designated as safety issue: No ]Lower pain ratings after 1 month treatment
| Estimated Enrollment: | 15 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
|
Device: AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Fibromyalgia diagnosis
- Over the age of 18
- Understands English
- Not pregrant/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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619579
Contacts
| Contact: Meegin Kincaid, B.S. | 858-552-8585 ext 2386 | mjkincaid@ucsd.edu |
Locations
| United States, California | |
| VA San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Meegin Kincaid, B.S. 858-552-8585 ext 2386 mjkincaid@ucsd.edu | |
| Principal Investigator: Tobias Moeller-Bertram, M.D., MAS | |
Sponsors and Collaborators
University of California, San Diego
More Information
Additional Information:
No publications provided
| Responsible Party: | Tobias Moeller-Bertram, Associate Clinical Professor of Anesthesiology, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01619579 History of Changes |
| Other Study ID Numbers: | 110973 |
| Study First Received: | June 12, 2012 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Diego:
|
Fibromyalgia Pain Non-Invasive |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013