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

Fibromyalgia Syndrome Clinical Trial

— VET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548065
• Other study ID #: AOUSenese
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: January 30, 2017
• Start date: April 1, 2015
• Est. completion date: January 30, 2017

Study information

• Verified date: January 2017
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2017
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Other:
• Balneotherapy
Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs
• Placebo
Bath with Thermal tap water

Locations

Country	Name	City	State
Italy	Fioravanti Antonella	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

Dönmez A, Karagülle MZ, Tercan N, Dinler M, Issever H, Karagülle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. — View Citation

Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 20% of VAS score	VAS score,	change from baseline at 15 days
Primary	Change of 20% Total FIQ	FIQ	change from baseline at 15 days
Secondary	Quality of life assessed by SF-12	SF-12	Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Secondary	Anxiety evaluation by STAI	STAI	Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Secondary	Depression assessed by CES-D	CES-D	Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Secondary	Widespread Pain assessed by WPI	WPI	Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Secondary	Symptom Severity assessed by SS scale	SS	Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.