NCT05801497

Balneotherapy in Primary Fibromyalgia

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 520 (estimated)
• Sponsor: University of Siena · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fibromyalgia, Primary

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2023-04-06
• Last updated: 2023-04-06

Locations

1 site across 1 country: Italy