Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      The present randomized, controlled double blind trial aims to evaluate the efficacy and
      tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in 100 patients
      with primary Fibromyalgia Syndrome (FS).
    

Detailed description: 
      The fibromyalgia syndrome (FS) is a chronic condition that is characterized by chronic
      widespread pain, fatigue, sleep disorders, cognitive disturbances, physical and psychological
      distress. It was estimated that between 2.9 and 3.8% of the general population in Europe and
      the US are affected , with the majority of patients in clinical settings being female .
      Clinical research suggests that pharmacologic treatment alone is not the best approach for
      FS, and that an integrated approach that includes non-pharmacologic therapies along with
      pharmacologic therapies improves outcomes in these patients.

      Balneotherapy is one of the most commonly used non-pharmacological approaches for SF, but it
      is still being discussed and its role in modern medicine is still not clear. The action
      mechanisms of thermal baths are not completely known, and it is difficult to distinguish the
      effects of thermal applications from the benefits that could be derived from a stay in a spa
      environment.

      The present randomized, controlled double blind trial aims to evaluate the efficacy and
      tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in patients with
      primary SF fulfilling the 2010 ACR criteria.

      Following confirmation that the patients fulfill the screening criteria and having obtained
      written informed consent, 100 patients will be randomized 1:1 and allocated to one of two
      groups using a computer-generated table of random numbers:

      Group I (50 patients) will be treated with daily thermal-mineral bath with mineral water
      named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two
      weeks at Levico Terme Spa Center (Levico Terme, Italy)

      Group II (50 patients), the control group, will be treated with daily thermal bath with with
      tap water bath for a total of 12 applications carried out over a period of two weeks at
      Levico Terme Spa Center (Levico Terme, Italy)

      The block randomization list will be kept by individuals who have no contact with the
      investigators who assign patients to their randomized treatment, and who will not perform any
      patient assessment or conduct the statistical.

      All patients will undergo general medical evaluation and rheumatologic examination by the
      same physician before the start of the study. All the demographic, anamnestic and clinical
      data will be collected on identical questionnaires. Each patient will be assessed at baseline
      time (T0), after 2 weeks (T1),after 3 months (T2), 6 months (T3), following the beginning of
      the study.

      All assessments will be performed at Levico Terme Spa Centre by the same rheumatologist who
      will be blinded to which study arms the patients belongs. Laboratory analysis will be
      performed only at baseline.

      Assessments at each examination will include:

      Primary Outcome Measures

        -  Visual Analogue Scale (VAS);

        -  Fibromyalgia Impact Questionnaire total score (FIQ-Total) e Fibromyalgia Impact
           Questionnaire Physical score (FIQ-PI)

      Secondary Outcome Measures

        -  Widespread Pain Index (WPI)

        -  Symptom Severity (SS)

        -  Short Form Health Survey (SF-12)

        -  State-Trait Anxiety Inventory (STAI)

        -  Center for Epidemiologic Studies Depression Scale (CES-D)
    

Intervention name(s): Balneotherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs; Bath with Thermal tap water
Other intervention name(s): spa therapy; Tap water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia Syndrome; Balneotherapy; Vetriolo Water