Balneotherapy in Primary Fibromyalgia

NCT05801497 | Unknown

• 1 other identifier: FIBROTHERM
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

balneotherapy

Outcome Measures

Primary Outcomes (1)

• Minimal Clinically Important Difference (MCID)

  Percentage of patients achieving MCDI, defined as a reduction\>14% of FIQ-total score

  15 days

Secondary Outcomes (6)

• Visual Analogue Scale (VAS)

  basal time;15 days;45 days

• Fibromyalgia Impact Questionnaire (FIQ)

  basal time;15 days;45 days

• Short-Form Health Survey (SF-12)

  basal time;15 days;45 days

• State-Trait Anxiety Inventory (STAI)

  basal time;15 days;45 days

• Center for Epidemiologic Studies Depression Scale (CES-D)

  basal time;15 days;45 days

Study Arms (2)

Balneotherapy Group

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.

Procedure: Balneotherapy

Control Group

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.

Interventions

Balneotherapy PROCEDURE

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.

Balneotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants are stratified into two groups (BT Group and Control Group) based on whether or not balneotherapy or a cycle of bath combined with mud-packs will be added to the usual therapy for FS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Siena: lead
• Azienda Ospedaliera Universitaria Senese: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Balneology

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Antonella Fioravanti

CONTACT

+390577233345; fioravanti7@virgilio.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Coordinator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IT (1)