A Randomized Controlled Trial on the Effectiveness of Mild Water-filtered Near Infrared Whole-body Hyperthermia as an Adjunct to a Standard Multimodal Rehabilitation in the Treatment of Fibromyalgia

Journal: Clinical Journal of Pain. 23(1):67-75, January 2007.

Authors: Brockow, Thomas MD; Wagner, Andreas MD; Franke, Annegret PhD; Offenbacher, Martin MD, MPH; Resch, Karl L. MD, PhD.

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 with MR only in patients with Fibromyalgia (FM).

Methods: 139 patients of a German inpatient rehabilitation hospital meeting the American College of Rheumatology 1990 criteria for FM were randomly allocated to NI-WBH (heating-up 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. [Note: 38.1 degrees C translates to 100.58 degrees F]

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:
n 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). [Meaning the probability that the difference could be owing to chance would be about one in 100]
n Secondary analyses on pain intensity, FM-related quality of life and tender point assessment yielded similar results.
n Moderate effect sizes were observed for all outcome measures considered (range, 0.41 to 0.75).
n 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 near infrared whole-body hyperthermia (NI-WBH) is a worthwhile adjunct to MR in the treatment of FM.

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