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

NCT ID: NCT02548065

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2017-01-30

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).

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)

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Balneotherapy

Intervention Type: OTHER

Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Bath with Thermal tap water

Interventions

Balneotherapy

Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs

Intervention Type: OTHER

Placebo

Bath with Thermal tap water

Intervention Type: OTHER

Other Intervention Names

spa therapy; Tap water

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Senese

OTHER

Sponsor Role: lead

Responsible Party

Fioravanti Antonella

Assistant of Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonella Fioravanti, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Senese

Locations

Fioravanti Antonella

Siena, Siena, Italy

Countries

Italy

References

Guidelli GM, Tenti S, De Nobili E, Fioravanti A. Fibromyalgia syndrome and spa therapy: myth or reality? Clin Med Insights Arthritis Musculoskelet Disord. 2012;5:19-26. doi: 10.4137/CMAMD.S8797. Epub 2012 Feb 22.

Reference Type: BACKGROUND

PMID: 22408369 (View on PubMed)

Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.

Reference Type: BACKGROUND

PMID: 11354556 (View on PubMed)

Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.

Reference Type: BACKGROUND

PMID: 11254234 (View on PubMed)

Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.

Reference Type: BACKGROUND

PMID: 12070676 (View on PubMed)

Donmez A, Karagulle MZ, Tercan N, Dinler M, Issever H, Karagulle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. doi: 10.1007/s00296-005-0623-9. Epub 2005 Jun 17.

Reference Type: BACKGROUND

PMID: 15965635 (View on PubMed)

Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. doi: 10.1007/s00296-007-0358-x. Epub 2007 May 23.

Reference Type: BACKGROUND

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Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

Reference Type: RESULT

PMID: 20461783 (View on PubMed)

Fioravanti A, Manica P, Bortolotti R, Cevenini G, Tenti S, Paolazzi G. Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial. Clin Rheumatol. 2018 Aug;37(8):2203-2212. doi: 10.1007/s10067-018-4117-z. Epub 2018 May 5.

Reference Type: DERIVED

PMID: 29730741 (View on PubMed)

Other Identifiers

AOUSenese

Identifier Type: -

Identifier Source: org_study_id