Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
NCT ID: NCT01619579
Last Updated: 2017-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Interventions
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AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Major unstable psychiatric illness
* Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
18 Years
99 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
San Diego Veterans Healthcare System
FED
Avacen, Inc.
INDUSTRY
Responsible Party
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Locations
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VA San Diego
La Jolla, California, United States
Countries
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Related Links
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Device manufacturer's website
VA San Diego website. Location study is conducted.
Other Identifiers
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110973
Identifier Type: -
Identifier Source: org_study_id
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