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Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Fibromyalgia Syndrome (VET)

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ClinicalTrials.gov Identifier: NCT02548065
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Fioravanti Antonella, Azienda Ospedaliera Universitaria Senese

Brief 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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Other: Balneotherapy Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Balneotherapy
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)
Other: Balneotherapy
Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs
Other Name: spa therapy

Placebo Comparator: Placebo
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)
Other: Placebo
Bath with Thermal tap water
Other Name: Tap water




Primary Outcome Measures :
  1. Change of 20% of VAS score [ Time Frame: change from baseline at 15 days ]
    VAS score,

  2. Change of 20% Total FIQ [ Time Frame: change from baseline at 15 days ]
    FIQ


Secondary Outcome Measures :
  1. Quality of life assessed by SF-12 [ Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study. ]
    SF-12

  2. Anxiety evaluation by STAI [ Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study. ]
    STAI

  3. Depression assessed by CES-D [ Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study. ]
    CES-D

  4. Widespread Pain assessed by WPI [ Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study. ]
    WPI

  5. Symptom Severity assessed by SS scale [ Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study. ]
    SS



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Have a score of WPI≥7 and SS ≥ 5 or WPI 3-6 and SS≥9 screening and baseline visit
  • Provide written informed consent to participate in the study

Exclusion Criteria:• Concurrent participation in other therapeutic trials

  • Patients that have been treated with mud-pack therapy and/or balneotherapy in the last 6 months
  • 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
  • Presence of concurrent autoimmune or inflammatory disease, such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc.
  • Pregnant and nursing mothers
  • Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, within two years)
  • Routine daily use of narcotic analgesics or history of substance abuse
  • Patients unable to complete the questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548065


Locations
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Italy
Fioravanti Antonella
Siena, Italy, 53100
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
Investigators
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Principal Investigator: Antonella Fioravanti, MD Azienda Ospedaliera Universitaria Senese
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fioravanti Antonella, Assistant of Professor, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT02548065    
Other Study ID Numbers: AOUSenese
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Fioravanti Antonella, Azienda Ospedaliera Universitaria Senese:
Fibromyalgia Syndrome
Balneotherapy
Vetriolo Water
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases