Fibromyalgia Clinical Trial
Official title:
A Randomized Controlled Trial on the Effectiveness of Mild Water-Filtered Near Infrared Hyperthermia as an Adjunct to a Standard Multimodal Rehabilitation in the Treatment of Fibromyalgia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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