Therapeutic Patient Education for Fibromyalgia during Spa Therapy: The FiETT Randomized Controlled Trial.

Spa therapy is known to improve quality of life and diminish pain. We assessed the efficacy (Fibromyalgia Impact Questionnaire-FIQ) and safety at 6 months of a fibromyalgia-specific therapeutic patient education (TPE) program added to fibromyalgia-specific standardized spa therapy (SST), compared to SST alone, in a controlled randomized trial. We enrolled 157 patients, mostly women, attending spa centers in Southwest France in 2015-2016, and randomized them to SST + TPE (79) or SST (78). The intention-to-treat with "missing as failure" analysis showed a tendency toward a higher, though non-significant, benefit with TPE than without for FIQ (-9 vs. -3; p = 0.053) or pain intensity (-0.9 vs. -1.1; p = 0.58). In addition, pain relief (+3.2 vs. +4.3; p = 0.03) and fatigue (-1.6 vs. -3.7; p = 0.02) were significantly improved, and 87% patients in the SST + TPE arm still regularly practiced the physical exercises taught to them at 6 months. We suspect significant and lasting improvement from spa therapy, as well as our already well-informed and well-managed participants, to have prevented the demonstration of a significant benefit of TPE on FIQ.