NCT02548065

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

September 4, 2015

Last Update Submit

January 30, 2017

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia SyndromeBalneotherapyVetriolo Water

Outcome Measures

Primary Outcomes (2)

  • Change of 20% of VAS score

    VAS score,

    change from baseline at 15 days

  • Change of 20% Total FIQ

    FIQ

    change from baseline at 15 days

Secondary Outcomes (5)

  • Quality of life assessed by SF-12

    Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

  • Anxiety evaluation by STAI

    Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

  • Depression assessed by CES-D

    Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

  • Widespread Pain assessed by WPI

    Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

  • Symptom Severity assessed by SS scale

    Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.

Study Arms (2)

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)

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)

Other: Placebo

Interventions

BalneotherapyOTHER

Bath with mineral water named "Debole of Vetriolo" at 36°C, 15 minutes for 12 consecutive days in bathtubs

Also known as: spa therapy
Balneotherapy
PlaceboOTHER

Bath with Thermal tap water

Also known as: Tap water
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fioravanti Antonella

Siena, Siena, 53100, Italy

Location

Related Publications (8)

  • 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.

    PMID: 22408369BACKGROUND

  • Buskila 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.

    PMID: 11354556BACKGROUND

  • Neumann 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.

    PMID: 11254234BACKGROUND

  • Evcik 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.

    PMID: 12070676BACKGROUND

  • Donmez 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.

    PMID: 15965635BACKGROUND

  • Fioravanti 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.

    PMID: 17520260BACKGROUND

  • Wolfe 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.

    PMID: 20461783RESULT

  • Fioravanti 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.

    PMID: 29730741DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Balneology

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Antonella Fioravanti, MD

    Azienda Ospedaliera Universitaria Senese

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant of Professor

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

April 1, 2015

Primary Completion

October 31, 2016

Study Completion

January 30, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

IT(1)