Clinical Rheumatology

, Volume 37, Issue 8, pp 2203–2212 | Cite as

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial

  • Antonella Fioravanti
  • Patrizia Manica
  • Roberto Bortolotti
  • Gabriele Cevenini
  • Sara TentiEmail author
  • Giuseppe Paolazzi
Original Article


The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student’s t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. Trial registration: NCT02548065


Balneotherapy Double-blind trial Fibromyalgia Spa therapy 



The authors want to thank the Thermal Resort of Levico and Vetriolo, Levico Terme (Trento), Italy.


This study was supported by “Provincia Autonoma di Trento”. The sponsors of this study did not participate in the study design, in the collection, analysis, or the interpretation of data.

Compliance with ethical standards




  1. 1.
    Mease P (2005) Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures and treatment. J Rheumatol Suppl 75:6–21PubMedGoogle Scholar
  2. 2.
    Wolfe F, Brahler E, Hinz A, Häuser W (2013) Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res 65:777–785. CrossRefGoogle Scholar
  3. 3.
    Spaeth M (2009) Epidemiology, costs, and the economic burden of fibromyalgia. Arthritis Res Ther 11:117. CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluß E et al (2017) EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis 76:318–328. CrossRefPubMedGoogle Scholar
  5. 5.
    Goldenberg DL, Burckhardt C, Crofford L (2004) Management of fibromyalgia syndrome. JAMA 292:2388–2395CrossRefPubMedGoogle Scholar
  6. 6.
    Ablin J, Fitzcharles MA, Buskila D, Shir Y, Sommer C, Häuser W (2013) Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. Evid Based Complement Alternat Med 2013:485272. PubMedPubMedCentralCrossRefGoogle Scholar
  7. 7.
    McVeigh JG, McGaughey H, Hall M, Kane P (2008) The effectiveness of hydrotherapy in the management of fibromyalgia syndrome: a systematic review. Rheumatol Int 29:119–130. CrossRefPubMedGoogle Scholar
  8. 8.
    Langhorst J, Musial F, Klose P, Häuser W (2009) Efficacy of hydrotherapy in fibromyalgia syndrome—a meta-analysis of randomized controlled clinical trials. Rheumatology 48:1155–1159. CrossRefPubMedGoogle Scholar
  9. 9.
    Guidelli GM, Tenti S, De Nobili E, Fioravanti A (2012) Fibromyalgia syndrome and spa therapy: myth or reality? Clin Med Insights Arthritis Musculoskelet Disord 5:19–26. CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Naumann J, Sadaghiani C (2014) Therapeutic benefit of balneotherapy and hydrotherapy in the management of fibromyalgia syndrome: a qualitative systematic review and meta-analysis of randomized controlled trials. Arthritis Res Ther 16:R141. CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Wolfe F, Clauw DJ, Fitzcharles M-A, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB (2010) The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 62:600–610. CrossRefGoogle Scholar
  12. 12.
    Burckhardt CS, Clark SR, Bennett RM (1991) The fibromyalgia impact questionnaire: development and validation. J Rheumatol 18:728–733PubMedGoogle Scholar
  13. 13.
    Bennett R (2005) The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 5(Suppl 39):S154–S162Google Scholar
  14. 14.
    Sarzi-Puttini P, Atzeni F, Fiorini T, Panni B, Randisi G, Turiel M, Carrabba M (2003) Validation of an Italian version of the Fibromyalgia Impact Questionnaire (FIQ-I). Clin Exp Rheumatol 21:459–464PubMedGoogle Scholar
  15. 15.
    Apolone G, Mosconi P (1998) The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 51:1025–1036CrossRefPubMedGoogle Scholar
  16. 16.
    Ware J Jr, Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233CrossRefPubMedGoogle Scholar
  17. 17.
    Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA (1983) Manual for the state-trait anxiety inventory. Consulting Psychologists Press, Inc, Palo AltoGoogle Scholar
  18. 18.
    Lazzari R, Pancheri P (1980) Questionario di autovalutazione per l’ansia di stato e di tratto. Manuale di istruzioni. Ed. Organizzazioni Speciali, FirenzeGoogle Scholar
  19. 19.
    Radloff LS (1977) The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1:385–401CrossRefGoogle Scholar
  20. 20.
    Fava GA (1983) Assessing depressive symptoms across cultures: Italian validation of the CES-D self-rating scale. J Clin Psychol 39:249–251CrossRefPubMedGoogle Scholar
  21. 21.
    Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL (2000) Defining the clinically important difference in pain outcome measures. Pain 88:287–294CrossRefPubMedGoogle Scholar
  22. 22.
    Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB (2009) Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol 36:1304–1311. CrossRefPubMedGoogle Scholar
  23. 23.
    Fraioli A, Grassi M, Mennuni G, Geraci A, Petraccia L, Fontana M, Conte S, Serio A (2013) Clinical researches on the efficacy of spa therapy in fibromyalgia. A systematic review. Ann Ist Super Sanita 49:219–229. PubMedCrossRefGoogle Scholar
  24. 24.
    Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D (2001) The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol 20:15–19CrossRefPubMedGoogle Scholar
  25. 25.
    Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S (2001) Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int 20:105–108CrossRefPubMedGoogle Scholar
  26. 26.
    Evcik D, Kizilay B, Gökçen E (2002) The effects of balneotherapy on fibromyalgia patients. Rheumatol Int 22:56–59CrossRefPubMedGoogle Scholar
  27. 27.
    Dönmez A, Karagülle MZ, Tercan N, Dinler M, Işsever H, Karagülle M et al (2005) SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int 26:168–172CrossRefPubMedGoogle Scholar
  28. 28.
    Zijlstra TR, van de Laar MA, Bernelot Moens HJ, Taal E, Zakraoui L, Rasker JJ (2005) Spa treatment for primary fibromyalgia syndrome: a combination of thalassotherapy, exercise and patient education improves symptoms and quality of life. Rheumatology (Oxford) 44:539–546CrossRefGoogle Scholar
  29. 29.
    Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F (2007) Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int 27:1157–1161CrossRefPubMedGoogle Scholar
  30. 30.
    Ozkurt S, Dönmez A, Zeki Karagülle M, Uzunoğlu E, Turan M, Erdoğan N (2012) Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study. Rheumatol Int 32:1949–1954. CrossRefPubMedGoogle Scholar
  31. 31.
    Bağdatlı AO, Donmez A, Eröksüz R, Bahadır G, Turan M, Erdoğan N (2015) Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study. Int J Biometeorol 59:1905–1911. CrossRefPubMedGoogle Scholar
  32. 32.
    Koçyiğit BF, Gür A, Altındağ Ö, Akyol A, Gürsoy S (2016) Comparison of education and balneotherapy efficacy in patients with fibromyalgia syndrome: a randomized, controlled clinical study. Agri 28:72–78. PubMedCrossRefGoogle Scholar
  33. 33.
    Tenti S, Fioravanti A, Guidelli GM, Pascarelli NA, Cheleschi S (2014) New evidence on mechanisms of action of spa therapy in rheumatic diseases. TANG 4:31–38Google Scholar
  34. 34.
    Cozzi F, Lazzarin P, Todesco S, Cima L (1995) Hypothalamic-pituitary-adrenal axis dysregulation in healthy subjects undergoing mud-bath applications. Arthritis Rheum 38:724–726CrossRefPubMedGoogle Scholar
  35. 35.
    Morer C, Roques CF, Françon A, Forestier R, Maraver F (2017) The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials. Int J Biometeorol 61:2159–2173. CrossRefPubMedGoogle Scholar
  36. 36.
    Bálint GP, Buchanan WW, Adám A, Ratkó I, Poór L, Bálint PV et al (2007) The effect of the thermal mineral water of Nagybaracska on patients with knee joint osteoarthritis—a double blind study. Clin Rheumatol 26:890–894CrossRefPubMedGoogle Scholar
  37. 37.
    Kovács C, Pecze M, Tihanyi Á, Kovács L, Balogh S, Bender T (2012) The effect of sulphurous water in patients with osteoarthritis of hand. Double-blind, randomized, controlled follow-up study. Clin Rheumatol 31:1437–1442. CrossRefPubMedGoogle Scholar
  38. 38.
    Kulisch A, Bender T, Németh A, Szekeres L (2009) Effect of thermal water and adjunctive electrotherapy on chronic low back pain: a double-blind, randomized, follow-up study. J Rehabil Med 41:73–79. CrossRefPubMedGoogle Scholar
  39. 39.
    Karagülle M, Karagülle MZ (2015) Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence. Clin Rheumatol 34:207–214. CrossRefPubMedGoogle Scholar
  40. 40.
    Prandelli C, Parola C, Buizza L, Delbarba A, Marziano M, Salvi V, Zacchi V, Memo M, Sozzani S, Calza S, Uberti D, Bosisio D (2013) Sulphurous thermal water increases the release of the anti-inflammatory cytokine IL-10 and modulates antioxidant enzyme activity. Int J Immunopathol Pharmacol 26:633–646CrossRefPubMedGoogle Scholar
  41. 41.
    Bender T, Bariska J, Vághy R, Gomez R, Kovács I (2007) Effect of balneotherapy on the antioxidant system-a controlled pilot study. Arch Med Res 38:86–89CrossRefPubMedGoogle Scholar
  42. 42.
    Cordero MD, Alcocer-Gómez E, Cano-García FJ, De Miguel M, Carrión AM, Navas P et al (2011) Clinical symptoms in fibromyalgia are better associated to lipid peroxidation levels in blood mononuclear cells rather than in plasma. PLoS One 6:e26915. CrossRefPubMedPubMedCentralGoogle Scholar
  43. 43.
    Fatima G, Das SK, Mahdi AA (2017) Some oxidative and antioxidative parameters and their relationship with clinical symptoms in women with fibromyalgia syndrome. Int J Rheum Dis 20:39–45. CrossRefPubMedGoogle Scholar
  44. 44.
    Ardiç F, Ozgen M, Aybek H, Rota S, Cubukçu D, Gökgöz A (2007) Effects of balneotherapy on serum IL-1, PGE2 and LTB4 levels in fibromyalgia patients. Rheumatol Int 27:441–446. CrossRefPubMedGoogle Scholar
  45. 45.
    Sendur OF, Tastaban E, Turan Y, Ulman C (2008) The relationship between serum trace element levels and clinical parameters in patients with fibromyalgia. Rheumatol Int 28:1117–1121. CrossRefPubMedGoogle Scholar
  46. 46.
    Mease PJ, Clauw DJ, Christensen R, Crofford LJ, Gendreau RM, Martin SA, OMERACT Fibromyalgia Working Group et al (2011) Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update. J Rheumatol 38:1487–1495. CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© International League of Associations for Rheumatology (ILAR) 2018

Authors and Affiliations

  • Antonella Fioravanti
    • 1
  • Patrizia Manica
    • 2
  • Roberto Bortolotti
    • 3
  • Gabriele Cevenini
    • 4
  • Sara Tenti
    • 1
    Email author
  • Giuseppe Paolazzi
    • 3
  1. 1.Rheumatology Unit, Department of Medicine, Surgery and NeurosciencesUniversity of SienaSienaItaly
  2. 2.Thermal Resort of Levico and VetrioloTrentoItaly
  3. 3.Rheumatology UnitS. Chiara HospitalTrentoItaly
  4. 4.Department of Medical BiotechnologiesUniversity of SienaSienaItaly

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