Evaluation of Spa Therapy in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

— THERMALGI  

Official title:

Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265029
• Other study ID #: DCIC/13/68
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: January 2019
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.

Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

Description:

THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) > 39 will be randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• both sexes, more than 18 years old patients

• available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months

• with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months

• with a FIQ score > or = 39 (fibromyalgia moderate to severe)

• voluntary to participate to the study, informed consent form signed after appropriate information

• affiliation to the social security system or equivalent

Exclusion Criteria:

• contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)

• no previous spa treatment in rheumatology within 1 year prior to inclusion

• substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)

• subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)

• subject participating to an other clinical study inerventionnal

• pregnancy, parturient or breast feeding

• no psychiatric illness or social situation that would preclude study compliance

Related Conditions & MeSH terms

• Collagen Diseases
• Fibromyalgia
• Myofascial Pain Syndromes
• Rheumatic Diseases
• Rheumatism, Muscular

Intervention

Other:
• Immediate spa treatment
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
• Late spa treatment
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)

Locations

Country	Name	City	State
France	station thermale AIX LES BAINS	Aix les Bains
France	station thermale ALLEVARD LES BAINS	Allevard
France	station thermale BOURBON LANCY	Bourbon-Lancy
France	station thermale LAMALOU LES BAINS	Lamalou les Bains
France	Station thermale URIAGE LES BAINS	Uriage les bains

Sponsors (3)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	Floralis, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (52)

Adler GK, Kinsley BT, Hurwitz S, Mossey CJ, Goldenberg DL. Reduced hypothalamic-pituitary and sympathoadrenal responses to hypoglycemia in women with fibromyalgia syndrome. Am J Med. 1999 May;106(5):534-43. — View Citation

Altan L, Bingöl U, Aykaç M, Koç Z, Yurtkuran M. Investigation of the effects of pool-based exercise on fibromyalgia syndrome. Rheumatol Int. 2004 Sep;24(5):272-7. Epub 2003 Sep 24. — View Citation

Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ, Chappell AS. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry. 2009;11(5):237-44. doi: 10.4088/PCC.08m00680. — View Citation

Baranowsky J, Klose P, Musial F, Häuser W, Dobos G, Langhorst J. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int. 2009 Nov;30(1):1-21. doi: 10.1007/s00296-009-0977-5. Epub 2009 Aug 12. Review. Erratum in: Rheumatol Int. 2009 Nov;30(1):23. Rheumatol Int. 2009 Nov;30(1):23. Haeuser, Winfried [corrected to Häuser, Winfried].. — View Citation

Bellometti S, Galzigna L. Function of the hypothalamic adrenal axis in patients with fibromyalgia syndrome undergoing mud-pack treatment. Int J Clin Pharmacol Res. 1999;19(1):27-33. — View Citation

Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15. — View Citation

Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45. — View Citation

Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9. — View Citation

Bircan C, Karasel SA, Akgün B, El O, Alper S. Effects of muscle strengthening versus aerobic exercise program in fibromyalgia. Rheumatol Int. 2008 Apr;28(6):527-32. Epub 2007 Nov 3. — View Citation

Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27. — View Citation

Burckhardt CS, Mannerkorpi K, Hedenberg L, Bjelle A. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. J Rheumatol. 1994 Apr;21(4):714-20. — View Citation

Burckhardt CS. Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des. 2006;12(1):59-66. Review. — View Citation

Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. Review. — View Citation

Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1. Review. — View Citation

Buskila D, Neumann L, Vaisberg G, Alkalay D, Wolfe F. Increased rates of fibromyalgia following cervical spine injury. A controlled study of 161 cases of traumatic injury. Arthritis Rheum. 1997 Mar;40(3):446-52. — View Citation

Carville SF, Arendt-Nielsen L, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Späth M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. Epub 2007 Jul 20. Review. Erratum in: Ann Rheum Dis. 2015 Feb;74(2):476. Arendt-Nielsen, S [corrected to Arendt-Nielsen, L]. — View Citation

Cedraschi C, Desmeules J, Rapiti E, Baumgartner E, Cohen P, Finckh A, Allaz AF, Vischer TL. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management. Ann Rheum Dis. 2004 Mar;63(3):290-6. — View Citation

Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73. — View Citation

Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. Review. French. — View Citation

Dönmez A, Karagülle MZ, Tercan N, Dinler M, Issever H, Karagülle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. Epub 2005 Jun 17. — View Citation

Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. Epub 2002 Mar 29. — View Citation

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. Epub 2007 May 23. — View Citation

Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3. — View Citation

Furlan R, Colombo S, Perego F, Atzeni F, Diana A, Barbic F, Porta A, Pace F, Malliani A, Sarzi-Puttini P. Abnormalities of cardiovascular neural control and reduced orthostatic tolerance in patients with primary fibromyalgia. J Rheumatol. 2005 Sep;32(9):1787-93. — View Citation

Giske L, Vøllestad NK, Mengshoel AM, Jensen J, Knardahl S, Røe C. Attenuated adrenergic responses to exercise in women with fibromyalgia--a controlled study. Eur J Pain. 2008 Apr;12(3):351-60. Epub 2007 Sep 10. — View Citation

Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973. — View Citation

Hassett AL, Radvanski DC, Vaschillo EG, Vaschillo B, Sigal LH, Karavidas MK, Buyske S, Lehrer PM. A pilot study of the efficacy of heart rate variability (HRV) biofeedback in patients with fibromyalgia. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):1-10. Epub 2007 Jan 12. — View Citation

Jentoft ES, Kvalvik AG, Mengshoel AM. Effects of pool-based and land-based aerobic exercise on women with fibromyalgia/chronic widespread muscle pain. Arthritis Rheum. 2001 Feb;45(1):42-7. — View Citation

Kazlauskaite R, Evans AT, Villabona CV, Abdu TA, Ambrosi B, Atkinson AB, Choi CH, Clayton RN, Courtney CH, Gonc EN, Maghnie M, Rose SR, Soule SG, Tordjman K; Consortium for Evaluation of Corticotropin Test in Hypothalamic-Pituitary Adrenal Insufficiency. Corticotropin tests for hypothalamic-pituitary- adrenal insufficiency: a metaanalysis. J Clin Endocrinol Metab. 2008 Nov;93(11):4245-53. doi: 10.1210/jc.2008-0710. Epub 2008 Aug 12. — View Citation

Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. Review. — View Citation

Ledingham J, Doherty S, Doherty M. Primary fibromyalgia syndrome--an outcome study. Br J Rheumatol. 1993 Feb;32(2):139-42. — View Citation

Lerma C, Martinez A, Ruiz N, Vargas A, Infante O, Martinez-Lavin M. Nocturnal heart rate variability parameters as potential fibromyalgia biomarker: correlation with symptoms severity. Arthritis Res Ther. 2011;13(6):R185. doi: 10.1186/ar3513. Epub 2011 Nov 16. — View Citation

McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the manifestations of primary fibromyalgia. Arthritis Rheum. 1988 Sep;31(9):1135-41. — View Citation

McCracken LM, MacKichan F, Eccleston C. Contextual cognitive-behavioral therapy for severely disabled chronic pain sufferers: effectiveness and clinically significant change. Eur J Pain. 2007 Apr;11(3):314-22. Epub 2006 Jun 9. — View Citation

McVeigh JG, McGaughey H, Hall M, Kane P. The effectiveness of hydrotherapy in the management of fibromyalgia syndrome: a systematic review. Rheumatol Int. 2008 Dec;29(2):119-30. doi: 10.1007/s00296-008-0674-9. Epub 2008 Aug 27. Review. — View Citation

Moldofsky H, Inhaber NH, Guinta DR, Alvarez-Horine SB. Effects of sodium oxybate on sleep physiology and sleep/wake-related symptoms in patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study. J Rheumatol. 2010 Oct;37(10):2156-66. doi: 10.3899/jrheum.091041. Epub 2010 Aug 3. — View Citation

Moldofsky H, Lue FA, Mously C, Roth-Schechter B, Reynolds WJ. The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study. J Rheumatol. 1996 Mar;23(3):529-33. — View Citation

Morley S, Williams AC. RCTs of psychological treatments for chronic pain: progress and challenges. Pain. 2006 Apr;121(3):171-2. Epub 2006 Mar 2. — View Citation

Mostoufi SM, Afari N, Ahumada SM, Reis V, Wetherell JL. Health and distress predictors of heart rate variability in fibromyalgia and other forms of chronic pain. J Psychosom Res. 2012 Jan;72(1):39-44. doi: 10.1016/j.jpsychores.2011.05.007. Epub 2011 Jun 30. — View Citation

Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26. Review. — View Citation

Onieva-Zafra MD, Castro-Sánchez AM, Matarán-Peñarrocha GA, Moreno-Lorenzo C. Effect of music as nursing intervention for people diagnosed with fibromyalgia. Pain Manag Nurs. 2013 Jun;14(2):e39-46. doi: 10.1016/j.pmn.2010.09.004. Epub 2010 Nov 26. — View Citation

Ozkurt S, Dönmez A, Zeki Karagülle M, Uzunoglu E, Turan M, Erdogan N. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study. Rheumatol Int. 2012 Jul;32(7):1949-54. doi: 10.1007/s00296-011-1888-9. Epub 2011 Apr 2. — View Citation

Pioro-Boisset M, Esdaile JM, Fitzcharles MA. Alternative medicine use in fibromyalgia syndrome. Arthritis Care Res. 1996 Feb;9(1):13-7. — View Citation

Richards SC, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial. BMJ. 2002 Jul 27;325(7357):185. — View Citation

Russell IJ, Kamin M, Bennett RM, Schnitzer TJ, Green JA, Katz WA. Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol. 2000 Oct;6(5):250-7. — View Citation

Sayar K, Aksu G, Ak I, Tosun M. Venlafaxine treatment of fibromyalgia. Ann Pharmacother. 2003 Nov;37(11):1561-5. — View Citation

Sephton SE, Salmon P, Weissbecker I, Ulmer C, Floyd A, Hoover K, Studts JL. Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: results of a randomized clinical trial. Arthritis Rheum. 2007 Feb 15;57(1):77-85. — View Citation

Tomas-Carus P, Häkkinen A, Gusi N, Leal A, Häkkinen K, Ortega-Alonso A. Aquatic training and detraining on fitness and quality of life in fibromyalgia. Med Sci Sports Exerc. 2007 Jul;39(7):1044-50. — View Citation

van Koulil S, Effting M, Kraaimaat FW, van Lankveld W, van Helmond T, Cats H, van Riel PL, de Jong AJ, Haverman JF, Evers AW. Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis. 2007 May;66(5):571-81. Epub 2006 Aug 17. Review. — View Citation

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. — View Citation

Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. — View Citation

Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14. — View Citation

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handicap in everyday life	Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline	6 months
Secondary	Quality of life	Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome.; EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months.; Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.	at baseline, 3, 6, 9 and 12 months
Secondary	Pain evolution	Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months	at baseline, 3, 6, 9 and 12 months
Secondary	Sleep quality	Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months	at baseline, 3, 6, 9 and 12 months
Secondary	Fatigue	Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months	at baseline, 3, 6, 9 and 12 months
Secondary	Depression	Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months	at baseline, 3, 6, 9 and 12 months
Secondary	Ability to cope	Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months	at baseline, 6 and 12 months
Secondary	Physical activity	Evolution of Baecke score between baseline, 3, 6, 9 and 12 months; evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months	at baseline, 3, 6, 9 and 12 months
Secondary	Medico economic impact	Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.	at baseline, 3, 6, 9 and 12 months
Secondary	Objective physical activity	Record of day activity during one week with actigraphy at baseline, 3 and 6 months	at baseline, 3, and 6 months
Secondary	Objective sleep quality	Record of night activity and cardiac variability at baseline, 3 and 6 months	at baseline, 3, and 6 months