Clinical trial NCT05801497: Balneotherapy in Primary Fibromyalgia
Official title: Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia, Primary
Keywords: balneotherapy
Lead sponsor: University of Siena
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Senese
First posted: 2023-04-06
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Minimal Clinically Important Difference (MCID)
timeFrame: 15 days
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: basal time;15 days;45 days
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: basal time;15 days;45 days
measure: Short-Form Health Survey (SF-12)
timeFrame: basal time;15 days;45 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: basal time;15 days;45 days
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: basal time;15 days;45 days
measure: Adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
References: