Status:
COMPLETED
Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia
Lead Sponsor:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate whether mild walter-filtered near infrared hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal rehabilitation compared...
Detailed Description
Mild systemic heat agents, including infrared whole-body hyperthermia, are used as treatment options in multimodal rehabilitation programs for fibromyalgia in Germany. However, no randomized controlle...
Eligibility Criteria
Inclusion
- participants must meet the American College of Rheumatology 1990 criteria for fibromyalgia
- participants must report a score ≥ 4 on the pain intensity subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
- participants must report a score ≥ 4 on the normalized physical functioning subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
- participants must be aged between 18 and 70 years
Exclusion
- severe cardiovascular disease
- metabolic disease
- nervous system disorder
- blood coagulation disease
- cancer
- acute inflammatory disease
- status after organ transplantation
- reduced general health (Karnofsky Index ≤ 50)
- pregnant women
- breast feeding women
- persons involved in a pending litigation for early pensioning due to fibromyalgia
- persons planning to apply for a pension due to fibromyalgia
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00324441
Start Date
January 1 2004
End Date
July 1 2005
Last Update
May 11 2006
Active Locations (1)
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1
Rehabilitationsklinik Hoher Meissner
Bad Sooden-Allendorf, Hesse, Germany, 37242