<h3>Research Objectives</h3> to determine whether the addition of Whole-Body Cryostimulation (WBC) to a rehabilitation program is able to induce a greater reduction of pain, depressive symptoms, disease impact and improvement in function and sleep quality in female patients with fibromyalgia (FM) as compared to matched controls undergoing only a rehabilitation program. <h3>Design</h3> Randomized controlled trial. <h3>Setting</h3> Participants were recruited consecutively from the in-patients of the Rehabilitation Unit in our hospital. <h3>Participants</h3> We selected 45 patients with: i) age between 18 and 65 years; ii) FM diagnosed by a rheumatologist according to American College of Rheumatology criteria; iii) FM diagnosed for more than one year. 25 patients were randomly allocated to the WBC group and 20 patients to the control group. <h3>Interventions</h3> Daily 45-min physiotherapy and 45-min standard supervised adapted physical activity sessions for an average length of hospital stay of 26 days. Patients allocated to the WBC group received additional ten 2-minute WBC sessions at a temperature of -110°. <h3>Main Outcome Measures</h3> Pain severity (VAS 0-10); Disease impact (Fibromyalgia Impact Questionnaire); Depressive symptomatology(BDI-II25); Sleep quality (VAS 0-10); 6-min walking test (meters) were measured before (T0) and after the completion of the rehabilitation program (T1). <h3>Results</h3> No significant differences between groups at T0 in terms of age, BMI, pain duration, number of pain medications, and scores on questionnaires were observed. Both groups reported positive changes in all outcomes at T1. The between-group comparison showed a statistically larger magnitude of changes in the WBC group at T1, specifically, in pain severity, disease impact, sleep quality, and depressive symptoms. Statistically significant improvements in 6MWT were observed at T1 in both groups. The between-group comparison at T1 did not show significant differences, but longer distances walked were evident in the WBC group. <h3>Conclusions</h3> Our preliminary results suggest that WBC could represent an effective add-on treatment for improving pain, disease impact, sleep quality, and depressive symptoms in FM patients. Larger studies are needed to confirm our results. <h3>Author(s) Disclosures</h3> Nothing to disclose.
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