Using balneotherapy to treat primary fibromyalgia
Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms
This study is testing if adding balneotherapy, a type of water therapy, can help people with primary fibromyalgia feel better compared to those who only get their usual treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 520 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Siena Academic / other |
| Locations | 1 site (Siena) |
| Trial ID | NCT05801497 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of balneotherapy as a non-pharmacological treatment for patients with primary fibromyalgia syndrome. Participants will be divided into two groups: one receiving balneotherapy in addition to their usual treatment and a control group receiving only their usual treatment. The study will assess various health metrics, including pain levels and quality of life, at baseline and after specified intervals. The goal is to gather data that will provide insights into the role of balneotherapy in managing fibromyalgia symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with primary fibromyalgia who have stable treatment for at least three months and a Fibromyalgia Impact Questionnaire score of 39 or higher.
Not a fit: Patients with secondary fibromyalgia or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new non-drug treatment option for patients suffering from fibromyalgia.
How similar studies have performed: While balneotherapy has been recommended for fibromyalgia, this specific approach is novel and its effectiveness is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Siena
- Azienda Ospedaliera Universitaria Senese — Siena, Italy (Recruiting)
Study contacts
- Study coordinator: Antonella Fioravanti
- Email: fioravanti7@virgilio.it
- Phone: +390577233345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.