[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100251149":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":49,"collaborators":35,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":35,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":35,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Senese","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Balneotherapy","ACTIVE_COMPARATOR","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)",[13],"Other: Balneotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","daily thermal bath 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)",[19],"Other: Placebo",[21,26],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Bath with mineral water named \"Debole of Vetriolo\" at 36°C, 15 minutes for 12 consecutive days in bathtubs",[9],[25],"spa therapy",{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Bath with Thermal tap water",[15],[30],"Tap water",[32],{"name":33,"affiliation":5,"role":34},"Antonella Fioravanti, MD","PRINCIPAL_INVESTIGATOR",null,[37],{"facility":38,"status":35,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":35},"Fioravanti Antonella","Siena","53100","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],11.33064,43.31822,{"lat":47,"lon":46},{"type":34,"investigatorFullName":38,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Assistant of Professor","100251149","efficacy-and-tolerability-of-balneotherapy-with-mineral-water-named-debole-of-vetriolo-in-fibromyalgia-syndrome-100251149",false,"NCT02548065","Efficacy and Tolerability of Balneotherapy With Mineral Water Named\" Debole of Vetriolo\" in Fibromyalgia Syndrome","Efficacy and Tolerability of Balneotherapy With Mineral Water Named\" Debole of Vetriolo\" in Patients With Fibromyalgia Syndrome (FS): A Randomized Double Blind Controlled Clinical Trial","VET","Inclusion Criteria:\n\n* Patients suffering from FS according to American College of Rheumatology (ACR) criteria for at least 3 months and with a stable treatment for at least 4 weeks\n* Have a score of WPI≥7 and SS ≥ 5 or WPI 3-6 and SS≥9 screening and baseline visit\n* Provide written informed consent to participate in the study\n\nExclusion Criteria:• Concurrent participation in other therapeutic trials\n\n* Patients that have been treated with mud-pack therapy and\u002For balneotherapy in the last 6 months\n* Patients affected by neoplastic diseases in the last five years, with cardiovascular disease of recent onset, suffering from serious impairment of hematopoietic, renal and hepatic systems\n* Presence of concurrent autoimmune or inflammatory disease, such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc.\n* Pregnant and nursing mothers\n* Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, within two years)\n* Routine daily use of narcotic analgesics or history of substance abuse\n* Patients unable to complete the questionnaires","ALL","18 Years","65 Years",{"count":63,"type":64},100,"ACTUAL","INTERVENTIONAL",[67],"NA","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).",[70],"Fibromyalgia Syndrome",[70,9,72],"Vetriolo Water","COMPLETED","2017-01-30",{"date":76,"type":77},"2017-01-31","ESTIMATED",{"date":79,"type":64},"2015-04-01",{"date":74,"type":64},{"name":5,"class":6},1]