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Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia

2014-08-27 03:44:48 | BioPortfolio

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 to standard multimodal rehabilitation only in patients with fibromyalgia.

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 controlled clinical trial exists on their effectiveness for this condition.

This study is designed as an add-on study to evaluate the additional benefit of mild walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program compared to a standard multimodal rehabilitation program only. Standard multimodal rehabilitation is configured as usually applied in clinical trials with exercise, cognitive behavioral therapy, and health education as the main treatment components.

Mild walter-filtered near infrared hyperthermia (heating-up to 38.1 degrees C body core temperature followed by a 15-min heat retention period) is administered twice a week over 3 weeks during a rehabilitation hospital stay.

Primary outcome measures are measured at baseline, postintervention, 3 and 6 months postintervention. Analysis is done by intention to treat, for significance testing Repeated Measures ANCOVA is used.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Fibromyalgia

Intervention

Iratherm® 1000

Location

Rehabilitationsklinik Hoher Meissner
Bad Sooden-Allendorf
Hessen
Germany
37242

Status

Completed

Source

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:48-0400

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