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.

IntroductionMind-body medicine (MBM) focuses on stress reduction and lifestyle changes. The primary objective of this pilot trial was to test study feasibility of a complex integrative MBM program for patients with Crohn's disease (CD), especially in rural regions, and under pandemic conditions.MethodsPatients were stratified and randomized to the intervention group (IG) or the control group (CG). The intervention included a weekly 6-h session for 10 weeks. The CG (waiting list) received an initial 90-min workshop and started the intervention 9 months later. The primary outcome for study feasibility was recruitment and retention rates, as well as reasons for drop-out. The trial took place in Bamberg, Germany (September 2020 to December 2021).ResultsTotally 700 members of the German Crohn's and Colitis Organization—DCCV—were contacted. A total of 15% (102/700; 95% CI 12–17%) expressed interest to participate. Following screening, 41% (95% CI 32–50) were randomized to IG (n = 22) and CG (n = 20). The patients were on average (±standard deviation) 48 ± 13 years old, 67% were female, and have been suffering from CD for 20 ± 12 years. Patients traveled 71.5 ± 48.7 km (range: 9–227 km) to the intervention with no differences between IG and CG. At the 6-month follow-up, 36/42 (86%, 95% CI 74–95%) participants completed final assessment and 19/22 (86%, 95% CI 70–100%) the intervention. The most important reasons for non-responding were work-related (12/60; 20%) and for or drop-out pandemic-related anxiety (3/6). No patient and staff member became infected with SARS-CoV-2 during the study.ConclusionThe feasibility of the MBM study was confirmed in terms of predefined recruitment and retention criteria, both despite difficult conditions (including the rural setting) and patients' fears associated with the pandemic. It was crucial to develop appropriate hygiene and safety concepts that enable chronically ill patients to participate in helpful group-based interventions even under pandemic conditions.Clinical trial registrationClinicalTrials.gov, identifier: NCT05182645.

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