Mild Water-Filtered Infrared-A Whole-Body Hyperthermia Reduces Pain in Patients with Fibromyalgia Syndrome—A Randomized Sham-Controlled Trial

Abstract

The challenging treatment situation of patients with fibromyalgia syndrome (FMS) requires additional therapy options. The effects of water-filtered infrared-A whole-body hyperthermia (WBH) versus sham hyperthermia on pain intensity were investigated in an outpatient setting within a two-armed randomized sham-controlled trial. n = 41 participants aged between 18 and 70 years with a medically confirmed diagnosis of FMS were randomized to WBH (intervention; n = 21) or sham hyperthermia (control; n = 20). Six treatments with mild water-filtered infrared-A WBH over a period of three weeks with at least one day in between treatments were applied. On average, the maximum temperature was 38.7 °C for a duration of approximately 15 min. The control group received exactly the same treatment except that an insulating foil between the patient and the hyperthermia device blocked most of the radiation. Primary outcome was pain intensity measured by the Brief Pain Inventory at week 4. Secondary outcomes included blood cytokine levels and FMS-related core symptoms and quality of life. Pain intensity at week 4 was significantly different between the groups in favor of WBH (p = 0.015). A statistically significant pain reduction in favor of WBH was also found at week 30 (p = 0.002). Mild water-filtered infrared-A WBH effectively reduced pain intensity at the end of treatment and follow-up.

Investigating the Influential Factors of Mild Water-Filtered Infrared-A Whole-Body Hyperthermia for Pain Relief in Fibromyalgia: A Mixed-Methods Approach Focusing on Predictors and Patient Perspectives

“…Participants with contraindications for hyperthermia such as increased body temperature (>37.5 • C) or heart failure, and previous experience with WBH were also excluded. More details can be found in Langhorst et al 2023 [34].…”

“…After treatment, participants rested for about 30 min (resting phase). Subjects were permanently supervised by the performing therapist and a physician was always on call [34].…”

“…Based on these trials, our working group conducted a randomized sham-controlled trial in an outpatient setting, by creating an adequate sham condition with high credibility [34]. The key difference between the two conditions was that the subjects received significantly less heat by covering the device with an insulating foil.…”

“…It is therefore of high relevance to gain further insight into the mechanisms of pain relief using mild WBH application by investigating possible predictors for the effectiveness of WBH. When looking at WBH studies, one sees, among other things, differences in the target temperature (38.1-38.5 • C) and the duration of the hyperthermia phases (e.g., plateau or resting phase) or sessions, which may be relevant for the outcome of the treatment [28,30,34]. Based on the study situation, the German guideline on WBH recommends a plateau phase of 15 min [35].…”

Multiscale Transfer Printing via Shape Memory Polymer with High Adhesion and Modulus Switchability

“…Moreover, hyperthermia treatment often requires multiple sessions during one period. 57 Therefore, a 10cycle test was conducted, and the temperature change was recorded. The hyperthermia patch was initially subjected to a 6 V voltage for the first 5 min, followed by the voltage being turned off for cooling for the remaining 5 min, which constituted one period.…”