Balneotherapy in Primary Fibromyalgia

Fibromyalgia, Primary Clinical Trial

Official title:

Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801497
• Other study ID #: FIBROTHERM
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: University of Siena
• Contact: Antonella Fioravanti
• Phone: +390577233345
• Email: fioravanti7[@]virgilio.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Balneotherapy (BT) is recommended as non-pharmacological treatment for Fibromyalgia Syndrome (FS). BT efficacy is based on beneficial properties of both mud bath and stay in a spa environment. The main aim of this multicentric prospective longitudinal cohort study is to evaluate BT effectiveness in patients withFS. All FS patients with a stable treatment in the past month and a Fibromyalgia Impact Questionnaire (FIQ) score ≥39 will be enrolled after providing written informed consent. Patients will be divided into two groups based on whether or not BT is added to usual therapy: BT Group and Control Group. Each patients will be assessed at baseline, after 15 and 45 days in BT Group and at baseline and after 15 days in Control group with an assessment of pain by Visual Analogue Scale, FIQ, Short-Form Health Survey, State-Trait Anxiety Inventory (STAI) and Center for Epidemiologic Studies Depression Scale (CES-D). Collected data will provide a new insight of BT role and the removal of daily stress in FS management

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of primary FS according to the 2010 American College of Rheumatology (ACR) criteria;
• Pharmacological and non pharmacological treatment stable for at least 3 months;
• FIQ-Total score = 39

Exclusion Criteria:

• Secondary FS;
• Primary FS patients actually enrolled in other clinical trials;
• Patients who had receveid a cycle of BT or of mud-bath in the previous 6 months;
• Patients treated with intra-articular steroid injections of any joints in the previous 3 months;
• Pregnancy or breastfeeding;
• Cognitive or psychiatric disorders and history of substance abuse;
• Absolute and relative contraindications to BT

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia, Primary
• Myofascial Pain Syndromes

Intervention

Procedure:
• Balneotherapy
The patients in the BT group will be treated with 12 daily immersion in a bathtub or in a pool at a 37-38°C or with a combination of bath and mud-packs to carry out in a period of two weeks. The application of mud-packs will follow the standard procedure with a duration of 15-20 minutes at 40-45°C. After the treatment, patients will have 20-30 minutes of bed rest. To be included in the study, thermal interventions must be carried out with sulfourous, solfate, bicarbonate, saline or sodium chloride and arsenical-ferruginous mineral waters, according to the classification by Marotta and Sica.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (2)

Lead Sponsor	Collaborator
University of Siena	Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Clinically Important Difference (MCID)	Percentage of patients achieving MCDI, defined as a reduction>14% of FIQ-total score	15 days
Secondary	Visual Analogue Scale (VAS)	Assessment of pain on a 0-10-cm Visual Analogue Scale (VAS) with 0 = "no pain" and 10 = "the worst pain possible"	basal time;15 days;45 days
Secondary	Fibromyalgia Impact Questionnaire (FIQ)	FIQ is an extensively validated patient self-report questionnaire, evaluating the impact of FS on daily life. In this study, we will use the Italian version of the FIQ. It ranges from 0 to 100, with higher scores indicating greater impact of FS on functioning.	basal time;15 days;45 days
Secondary	Short-Form Health Survey (SF-12)	The 12-item SF-12 is a short version of SF-36 that is a widely used measure of health and well-being, validated in multiple countries, including Italy. SF-12 comprises two main domains: the physical component score (PCS) and the mental component score (MCS), and eight scales for assessing eight dimensions: physical functioning, physical role, social role, emotional role, bodily pain, general health, vitality, and mental health. Scores range from "0 to 100" where "0" indicates the worst condition and "100" indicates the best possible condition.	basal time;15 days;45 days
Secondary	State-Trait Anxiety Inventory (STAI)	STAI is a self-report questionnaire with two independent 20-item scales (STAI T-Anxiety Scale or Form X-2 and STAI S-Anxiety Scale or Form X-1) for measuring state-related or trait-related anxiety. A high score on the STAI corresponds to a high level of anxiety symptoms. We will use the Italian validated version.	basal time;15 days;45 days
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	The 20-item CES-D Scale is frequently used to estimate the prevalence of depressive symptomatology in the general population. Respondents rate the frequency with which they have experienced particular depressive symptoms during the past week. Responses to each item range from 0 (less than 1 day) to 3 (5-7 days) and are summed to compute a total score. The Italian version measures one depression factor scoring from 0 to 60; scores of 16 or above are considered cases of depression.	basal time;15 days;45 days
Secondary	Adverse events	Percentage of patients reporting adverse events	15 days