Fibromyalgia Clinical Trial
Official title:
Clinical Research, Randomized, Open, Unmasked, Controlled, Cross-group, Active-treatment, to Evaluate the Clinical Efficacy of Whole Body Cryotherapy (WBC) in the Cryosense TCT Cabin for the Treatment of Fibromyalgia
The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8 weeks.
The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3
minutes of whole body cryotherapy (WBC) in the Cryosense cabin, on the main clinical
manifestations of patients with Fibromyalgia (FM).
A randomized, open and crossed 8-week clinical trial comparing a WBC intervention with the
waiting list control group. Patients diagnosed with FM according to ACR 2010 criteria, in
treatment and regular follow-up recruited consecutively. Two groups were made, one of
intervention and one of waiting list which served as control during the first phase. At the
end of the first phase, and after a week of washout, the groups crossed and went on to carry
out the second phase following the opposite intervention. The pharmacological treatment was
not modified during the entire study.
Trial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale
(VAS) and burden of disease, evaluated by the Fibromyalgia Impact Questionnaire(FIQ).
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