Balneotherapy in Primary Fibromyalgia

University of Siena

Status: Enrolling

Conditions: Fibromyalgia, Primary

Treatments: Procedure: Balneotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05801497

FIBROTHERM

Details and patient eligibility

About

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

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

520 participants in 2 patient groups

Balneotherapy Group

Description:

Patients will receive a cycle of BT or a cycle of mud-bath therapy once daily for 12 days for a total duration of two weeks, in addition to their usual treatments for fibromyalgia. The bath can be performed both in a bathube or in a pool for 10 minutes, at a 37-38°C. The application of mud will follow the standard procedure with a duration of 15-20 minutes at 40-45°C. After the treatment, patients will relax for 20-30°C minutes. 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.

Treatment:

Procedure: Balneotherapy

Control Group

Description:

This group will include patients who will refuse the thermal treatment for personal reasons. Patients will continue their established routinary care for FS. The treatment must be stable for at least 3 months; some variations in analgesic consumption will be possible and will be collected in the clinical chart.