THU0347 Efficacy and safety of whole body cryotherapy in fibromyalgic patients

Abstract

Background Patients suffering from fibromyalgia (FM) had widespread musculoskeletal pain and stiffness, fatigue, sleep disorders, cognitive impairment and other symptoms, which seriously affects their quality of life (QoL), making it difficult to perform normal activities. Treatment of fibromyalgia is multidisciplinary, with an emphasis on active patient participation, medications, cognitive-behavioral therapy and physical modalities. But no single medication has yet been found to sufficiently control all the symptoms of FM, overall pain and fatigue. Whole Body Criotherapy (WBC) administered at –60°C/–140°C has suggested in several study a pain relief in rheumatic diseases associated to increased muscle strength and endurance. Objectives To evaluate the efficacy and the safety of WBC in patients with fibromyalgia. The primary efficacy outcome was defined as the change from baseline (Week 0) to Week 7 in patients’ evaluation of pain, measured by a 100-mm VAS (0 = “No Pain” and 100 = “Maximum Pain”). The secondary efficacy measure was the improvement in Fatigue questionnaire (FSS). Methods 49 randomly fibromyalgic patients (46 F; 3 M; mean age =37,7), meeting both 1990 ACR criteria and Wolfe criteria, using antioxydants agents and analgesics, have been included in this study. They underwent to medical examination and electrocardiogram to determine the suitability and the absence of absolute contraindications to WBC. Each of 49 patient underwent a cycle of 15 therapeutic sessions (5 consecutive days per week, for 3 consecutive weeks). At each session, just before the entrance into the cryochamber and after the therapy, each patient has been monitored for blood pressure, heart rate, oxygen saturation and axillary temperature. Patients stay about 1 minute at a temperature of – 60°C and, immediately after, about 2 minutes at – 140°C and wear a swimsuit, a mask without metals, wool gloves and socks, cover-ears and wooden clogs. At the end of the session patients underwent to specific rehabilitation treatment, at room temperature, for about 30 minutes. At the beginning and four weeks after the end of the cycle of WBC, patients are administered VAS pain and Fatigue questionnaire (FSS). The clinician performs tallying tender points. A second control group of 49 fibromyalgic patients (45 F; 4 M; mean age =39,2) also treated with antioxydants agents and analgesics underwent the same tests. No drug variations were admitted in the two groups during the 7 weeks of observation. Results Whole Body Cryotherapy was significantly superior (P <0.05) to the treatment with only antioxydants agents and analgesic, using the primary criterion (visual analog scale [VAS] assessment of pain). Significant improvement (P <0.05) was also observed for the secondary criteria (Fatigue score). No variations were registered in blood pressure, heart rate, oxygen saturation and axillary temperature. As in international experience we have not reported serious adverse reactions such as permanent injury and/or death. Conclusions Whole Body Cryotherapy...