Fibromyalgia, PrimaryNCT05801497
Balneotherapy in Primary Fibromyalgia
An observational study of Fibromyalgia, Primary, run by University of Siena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- Balneotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 520 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Antonella Fioravanti, +390577233345, fioravanti7@virgilio.it
About this study
Official title: Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms
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
- Being tested
- Balneotherapy
- Keywords
- balneotherapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalneotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Clinically Important Difference (MCID)
Percentage of patients achieving MCDI, defined as a reduction>14% of FIQ-total score
Measured: 15 days
Secondary outcomes (6)
Visual Analogue Scale (VAS)
Assessment of pain on a 0-10-cm Visual Analogue Scale (VAS) with 0 = "no pain" and 10 = "the worst pain possible"
Measured: basal time;15 days;45 days
Fibromyalgia Impact Questionnaire (FIQ)
FIQ is an extensively validated patient self-report questionnaire, evaluating the impact of FS on daily life. In this study, we will use the Italian version of the FIQ. It ranges from 0 to 100, with higher scores indicating greater impact of FS on functioning.
Measured: basal time;15 days;45 days
Short-Form Health Survey (SF-12)
The 12-item SF-12 is a short version of SF-36 that is a widely used measure of health and well-being, validated in multiple countries, including Italy. SF-12 comprises two main domains: the physical component score (PCS) and the mental component score (MCS), and eight scales for assessing eight dimensions: physical functioning, physical role, social role, emotional role, bodily pain, general health, vitality, and mental health. Scores range from "0 to 100" where "0" indicates the worst condition and "100" indicates the best possible condition.
Measured: basal time;15 days;45 days
State-Trait Anxiety Inventory (STAI)
STAI is a self-report questionnaire with two independent 20-item scales (STAI T-Anxiety Scale or Form X-2 and STAI S-Anxiety Scale or Form X-1) for measuring state-related or trait-related anxiety. A high score on the STAI corresponds to a high level of anxiety symptoms. We will use the Italian validated version.
Measured: basal time;15 days;45 days
Center for Epidemiologic Studies Depression Scale (CES-D)
The 20-item CES-D Scale is frequently used to estimate the prevalence of depressive symptomatology in the general population. Respondents rate the frequency with which they have experienced particular depressive symptoms during the past week. Responses to each item range from 0 (less than 1 day) to 3 (5-7 days) and are summed to compute a total score. The Italian version measures one depression factor scoring from 0 to 60; scores of 16 or above are considered cases of depression.
Measured: basal time;15 days;45 days
Adverse events
Percentage of patients reporting adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Senese
- Responsible party
- Principal investigator, fioravanti antonella, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801497
- Sponsor's protocol ID
- FIBROTHERM
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms
- ClinicalTrials.gov ID
- NCT05801497
- Acronym / sponsor ID
- FIBROTHERM
- Conditions
- Fibromyalgia, Primary
- Keywords
- balneotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Senese
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy Group | – | Procedure: BalneotherapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BalneotherapyThe 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. | Procedure or surgery | Balneotherapy Group |
Primary outcome
Minimal Clinically Important Difference (MCID)
Time frame: 15 days
Percentage of patients achieving MCDI, defined as a reduction>14% of FIQ-total score
6 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: basal time;15 days;45 days
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: basal time;15 days;45 days
Short-Form Health Survey (SF-12)
Time frame: basal time;15 days;45 days
State-Trait Anxiety Inventory (STAI)
Time frame: basal time;15 days;45 days
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: basal time;15 days;45 days
Adverse events
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, Primary, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Fioravanti (+390577233345, fioravanti7@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Clinically Important Difference (MCID) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.