Randomisierte, kontrollierte Studie zur Wirksamkeit und Verträglichkeit einer milden wassergefilterten Infrarot-A-Ganzkörperhyperthermie als Zusatzbehandlung zu einer multimodalen rehabilitativen Standardtherapie bei der Behandlung der Fibromyalgie

Objectives: To evaluate whether mild water-filtered near infrared whole-body hyperthermia (NI-WBH) produces an additional benefit when applied as an adjunct to a standard multimodal rehabilitation (MR) compared to MR only in patients with Fibromyalgia (FM). Methods: One hundred and thirty-nine patients of a German inpatient rehabilitation hospital meeting the ACR 1990 criteria for FM were randomly allocated to NI-WBH (heating-LIP to 38.1 degrees C body-core temperature followed by a 15 min heat retention period) and MR or MR only, twice a week over 3 weeks. Main outcome measures were affective and sensory pain assessed by a German version of the McGill Pain Questionnaire, measured at baseline, post-intervention, 3 and 6 months post-intervention and analyzed by intention to treat. Results: Repeated measures analysis of covariance showed significant differences between groups for both primary outcome measures in favor of NI-WBH and MR compared with MR only (p < 0.001 for affective pain, p=0.001 for sensory pain). Secondary analyses on pain intensity, FM-related quality of life and tender point assessment yielded similar results. Moderate effect sizes were observed for all outcome measures considered (range, 0.41-0.75). NI-WBH related side effects were observed in 14 of 69 participants (20%) but all disappeared in less than 30 minutes. Discussion: The study indicates that NI-WBH is a worthwhile adjunct to MR in the treatment of FM.