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

January 30, 2017 updated by: Fioravanti Antonella, Azienda Ospedaliera Universitaria Senese

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Fioravanti Antonella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Tap water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 20% of VAS score
Time Frame: change from baseline at 15 days
VAS score,
change from baseline at 15 days
Change of 20% Total FIQ
Time Frame: change from baseline at 15 days
FIQ
change from baseline at 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Anxiety evaluation by STAI
Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
STAI
Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
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
Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Widespread Pain assessed by WPI
Time Frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
WPI
Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
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
Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Senese

Investigators

  • Principal Investigator: Antonella Fioravanti, MD, Azienda Ospedaliera Universitaria Senese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOUSenese

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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