Balneotherapy in Fibromyalgia Syndrome: protocol of “FIBROTHERM”, a prospective multi-center, two-cohort observational study

Balneotherapy (BT) is considered an effective, non-pharmacological approach, in the multimodal treatment of the Primary Fibromyalgia Syndrome (FS). However, the evidence of efficacy and tolerability of BT in FS is still limited. This is a prospective multi-center two-cohort observational study. The main aim will be the comparison of the Minimal Clinically Important Difference (according to Fibromyalgia Impact Questionnaire—FIQ) achievement in FS patients treated with BT vs standard care. Secondary objectives will be to assess: a) BT impact on pain, quality of life, anxiety and depression; b) the persistence of benefits in six weeks c) BT safety profile. All FS patients with a stable treatment in the past 3 months and a moderate to severe disease (FIQ score ≥ 39) will be enrolled after providing written informed consent. Patients will be divided into two Cohort: a) BT Cohort (i.e., BT in addition to standard care)—BTC; b) Control Cohort (i.e., only standard care)—SCC. There will be three assessments: baseline, two and six weeks (i.e., one month after BT end in BTC). At each of them the subject will fill in the following questionnaires: FIQ, VAS pain, Short Form Health Survey 16, State-Trait Anxiety Inventory and Center for Epidemiological Studies Depression Scale. We expect to observe a more relevant improvement of disease activity in BTC than in SCC. The positive effect may extend even to pain, quality of life, anxiety and depression. The short- and medium-term effects are likely to be similar, without any significant warning in terms of tolerability. Collected data, deriving from a large sample of patients, will provide a new insight of BT role in moderate to severe FS treatment. In particular, it will be possible to quantify the short and medium-term BT impact on disease activity and secondary symptoms related to FS.