Fibromyalgia SyndromeVETNCT02548065
Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Fibromyalgia Syndrome
A study testing Balneotherapy in people with Fibromyalgia Syndrome, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
Trial summary
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in 100 patients with primary Fibromyalgia Syndrome (FS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Balneotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2015to 30 Jan 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from FS according to American College of Rheumatology (ACR) criteria for at least 3 months and with a stable treatment for at least 4 weeks
- Have a score of WPI≥7 and SS ≥ 5 or WPI 3-6 and SS≥9 screening and baseline visit
- Provide written informed consent to participate in the study
- Exclusion Criteria:• Concurrent participation in other therapeutic trials
- Patients that have been treated with mud-pack therapy and/or balneotherapy in the last 6 months
- Patients affected by neoplastic diseases in the last five years, with cardiovascular disease of recent onset, suffering from serious impairment of hematopoietic, renal and hepatic systems
Show all 11Show fewer
- Presence of concurrent autoimmune or inflammatory disease, such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc.
- Pregnant and nursing mothers
- Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, within two years)
- Routine daily use of narcotic analgesics or history of substance abuse
- Patients unable to complete the questionnaires
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Patients With Fibromyalgia Syndrome (FS): A Randomized Double Blind Controlled Clinical Trial
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in 100 patients with primary Fibromyalgia Syndrome (FS).
Read the detailed description
The fibromyalgia syndrome (FS) is a chronic condition that is characterized by chronic widespread pain, fatigue, sleep disorders, cognitive disturbances, physical and psychological distress. It was estimated that between 2.9 and 3.8% of the general population in Europe and the US are affected , with the majority of patients in clinical settings being female . Clinical research suggests that pharmacologic treatment alone is not the best approach for FS, and that an integrated approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.
Balneotherapy is one of the most commonly used non-pharmacological approaches for SF, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment.
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in patients with primary SF fulfilling the 2010 ACR criteria.
Following confirmation that the patients fulfill the screening criteria and having obtained written informed consent, 100 patients will be randomized 1:1 and allocated to one of two groups using a computer-generated table of random numbers:
Group I (50 patients) will be treated with daily thermal-mineral bath with mineral water named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy)
Group II (50 patients), the control group, will be treated with daily thermal bath with with tap water bath for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy)
The block randomization list will be kept by individuals who have no contact with the investigators who assign patients to their randomized treatment, and who will not perform any patient assessment or conduct the statistical.
All patients will undergo general medical evaluation and rheumatologic examination by the same physician before the start of the study. All the demographic, anamnestic and clinical data will be collected on identical questionnaires. Each patient will be assessed at baseline time (T0), after 2 weeks (T1),after 3 months (T2), 6 months (T3), following the beginning of the study.
All assessments will be performed at Levico Terme Spa Centre by the same rheumatologist who will be blinded to which study arms the patients belongs. Laboratory analysis will be performed only at baseline.
Assessments at each examination will include:
Primary Outcome Measures
- Visual Analogue Scale (VAS);
- Fibromyalgia Impact Questionnaire total score (FIQ-Total) e Fibromyalgia Impact Questionnaire Physical score (FIQ-PI)
Secondary Outcome Measures
- Widespread Pain Index (WPI)
- Symptom Severity (SS)
- Short Form Health Survey (SF-12)
- State-Trait Anxiety Inventory (STAI)
- Center for Epidemiologic Studies Depression Scale (CES-D)
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Balneotherapy, Placebo
- Keywords
- Fibromyalgia Syndrome, Balneotherapy, Vetriolo Water
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalneotherapyOther
Also called spa therapy
Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs
PlaceboOther
Also called Tap water
Bath with Thermal tap water
| Study group | Role | What they receive |
|---|---|---|
| Balneotherapy | Active comparator | Daily thermal-mineral bath with mineral water named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy) Receives: Other: Balneotherapy |
| Placebo | Placebo comparator | daily thermal bath with tap water bath for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 20% of VAS score
VAS score,
Measured: change from baseline at 15 days
Change of 20% Total FIQ
FIQ
Measured: change from baseline at 15 days
Secondary outcomes (5)
Quality of life assessed by SF-12
SF-12
Measured: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Anxiety evaluation by STAI
STAI
Measured: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Depression assessed by CES-D
CES-D
Measured: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Widespread Pain assessed by WPI
WPI
Measured: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Symptom Severity assessed by SS scale
SS
Measured: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Oct 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fioravanti Antonella, Azienda Ospedaliera Universitaria Senese
- Investigators
- Antonella Fioravanti, MD, Principal investigator, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548065
- Sponsor's protocol ID
- AOUSenese
- Acronym
- VET
- Status last verified
- Jan 2017
- First submitted
- 4 Sep 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guidelli GM, Tenti S, De Nobili E, Fioravanti A. Fibromyalgia syndrome and spa therapy: myth or reality? Clin Med Insights Arthritis Musculoskelet Disord. 2012;5:19-26. doi: 10.4137/CMAMD.S8797. Epub 2012 Feb 22.
PubMed 22408369Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.
PubMed 11354556Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.
PubMed 11254234Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.
PubMed 12070676Donmez A, Karagulle MZ, Tercan N, Dinler M, Issever H, Karagulle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. doi: 10.1007/s00296-005-0623-9. Epub 2005 Jun 17.
PubMed 15965635Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. doi: 10.1007/s00296-007-0358-x. Epub 2007 May 23.
PubMed 17520260Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Fioravanti A, Manica P, Bortolotti R, Cevenini G, Tenti S, Paolazzi G. Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial. Clin Rheumatol. 2018 Aug;37(8):2203-2212. doi: 10.1007/s10067-018-4117-z. Epub 2018 May 5.
PubMed 29730741
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Patients With Fibromyalgia Syndrome (FS): A Randomized Double Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02548065
- Acronym / sponsor ID
- VET / AOUSenese
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome, Balneotherapy, Vetriolo Water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 14 Sep 2015 (estimated)
- 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.
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in 100 patients with primary Fibromyalgia Syndrome (FS).
Detailed description
The fibromyalgia syndrome (FS) is a chronic condition that is characterized by chronic widespread pain, fatigue, sleep disorders, cognitive disturbances, physical and psychological distress. It was estimated that between 2.9 and 3.8% of the general population in Europe and the US are affected , with the majority of patients in clinical settings being female . Clinical research suggests that pharmacologic treatment alone is not the best approach for FS, and that an integrated approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.
Balneotherapy is one of the most commonly used non-pharmacological approaches for SF, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment.
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in patients with primary SF fulfilling the 2010 ACR criteria.
Following confirmation that the patients fulfill the screening criteria and having obtained written informed consent, 100 patients will be randomized 1:1 and allocated to one of two groups using a computer-generated table of random numbers:
Group I (50 patients) will be treated with daily thermal-mineral bath with mineral water named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy)
Group II (50 patients), the control group, will be treated with daily thermal bath with with tap water bath for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy)
The block randomization list will be kept by individuals who have no contact with the investigators who assign patients to their randomized treatment, and who will not perform any patient assessment or conduct the statistical.
All patients will undergo general medical evaluation and rheumatologic examination by the same physician before the start of the study. All the demographic, anamnestic and clinical data will be collected on identical questionnaires. Each patient will be assessed at baseline time (T0), after 2 weeks (T1),after 3 months (T2), 6 months (T3), following the beginning of the study.
All assessments will be performed at Levico Terme Spa Centre by the same rheumatologist who will be blinded to which study arms the patients belongs. Laboratory analysis will be performed only at baseline.
Assessments at each examination will include:
Primary Outcome Measures
- Visual Analogue Scale (VAS);
- Fibromyalgia Impact Questionnaire total score (FIQ-Total) e Fibromyalgia Impact Questionnaire Physical score (FIQ-PI)
Secondary Outcome Measures
- Widespread Pain Index (WPI)
- Symptom Severity (SS)
- Short Form Health Survey (SF-12)
- State-Trait Anxiety Inventory (STAI)
- Center for Epidemiologic Studies Depression Scale (CES-D)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy | Active comparator | Other: BalneotherapyDaily thermal-mineral bath with mineral water named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy) |
| Placebo | Placebo comparator | Other: Placebodaily thermal bath with tap water bath for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients suffering from FS according to American College of Rheumatology (ACR) criteria for at least 3 months and with a stable treatment for at least 4 weeks
- Have a score of WPI≥7 and SS ≥ 5 or WPI 3-6 and SS≥9 screening and baseline visit
- Provide written informed consent to participate in the study
- Exclusion Criteria:• Concurrent participation in other therapeutic trials
- Patients that have been treated with mud-pack therapy and/or balneotherapy in the last 6 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BalneotherapyAlso: spa therapyBath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs | Other | Balneotherapy |
| PlaceboAlso: Tap waterBath with Thermal tap water | Other | Placebo |
Primary outcome
Change of 20% of VAS score
Time frame: change from baseline at 15 days
VAS score,
Change of 20% Total FIQ
Time frame: change from baseline at 15 days
FIQ
5 secondary outcomes
Quality of life assessed by SF-12
Time frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Anxiety evaluation by STAI
Time frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Depression assessed by CES-D
Time frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Widespread Pain assessed by WPI
Time frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Symptom Severity assessed by SS scale
Time frame: Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 22408369Guidelli GM, Tenti S, De Nobili E, Fioravanti A. Fibromyalgia syndrome and spa therapy: myth or reality? Clin Med Insights Arthritis Musculoskelet Disord. 2012;5:19-26. doi: 10.4137/CMAMD.S8797. Epub 2012 Feb 22.
- Background: PubMed 11354556Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.
- Background: PubMed 11254234Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.
- Background: PubMed 12070676Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.
- Background: PubMed 15965635Donmez A, Karagulle MZ, Tercan N, Dinler M, Issever H, Karagulle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. doi: 10.1007/s00296-005-0623-9. Epub 2005 Jun 17.
- Background: PubMed 17520260Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. doi: 10.1007/s00296-007-0358-x. Epub 2007 May 23.
- Results publication: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Derived from this study: PubMed 29730741Fioravanti A, Manica P, Bortolotti R, Cevenini G, Tenti S, Paolazzi G. Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial. Clin Rheumatol. 2018 Aug;37(8):2203-2212. doi: 10.1007/s10067-018-4117-z. Epub 2018 May 5.
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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.
Antonella Fioravanti, MD principal investigator
Azienda Ospedaliera Universitaria Senese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balneotherapy in people with Fibromyalgia Syndrome, run by Azienda Ospedaliera Universitaria Senese 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 11 inclusion and 0 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: finished, as of the sponsor's last update on 31 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 20% of VAS score (time frame: change from baseline at 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548065, which also lists 8 linked publications.
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 31 Jan 2017.