Back to resultsFibromyalgia Therapeutic Education in Thermal Cure (FiETT)
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CTS
ETP
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria
- Diagnostic of fibromyalgia done at least 6 months before thermal cure
- Diagnostic of fibromyalgia confirmed by FIRST questionnaire (score 5) during the initial thermal checkup
- Age between 18 and 65 years
- Access to an Internet connection during remote follow-up
- Affiliation to a social security system (recipient or assignee)
- Signed written inform consent form
Exclusion Criteria
- Infectious diseases with ongoing treatment (except for winter upper respiratory tract pathologies)
- Active tumorous pathology
- Concomitant inflammatory rheumatism
- Stage III chronic venous insufficiency with history of phlebitis and/or pulmonary embolism
- Incapacity to receive treatment in hot water ( ≥36°)
- Total incapacity to practice physical activities of therapeutic education program
- Ongoing pregnancy
- Involvement in a structured educational program specific to fibromyalgia during the previous year
- Incapacity to understand French language making the follow up impossible
Sites / Locations
- OTD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CTS + ETP
CTS alone
Arm Description
Patients following a standardized thermal cure (CTS) follow an additional program called Fibr'eaux (ETP) that consists in discussion groups and physical activities allowing patients to learn how to manage their illness.
Patients follow a standardized thermal cure that is a sedative, relaxing, antalgic and mobilizing treatment based on muds application, hydrotherapy and physiotherapy. The cure is made of 72 treatments selected among a list including muds application, massages, reeducation in thermal pool, baths and showers.
Outcomes
Primary Outcome Measures
Change in quality of life
Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.
Secondary Outcome Measures
Change in quality of life
Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Responder rate
Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00
Pain intensity
Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Pain relief
Average change from baseline in pain relief measured on a VAS
Kinesiophobia index
Average change from baseline in kinesiophobia measured by TAMPA scale
Catastrophizing index
Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)
Function impairment
Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale
Fatigue
Average change from baseline in fatigue measured by Picot scale
Somnolence
Average change from baseline in somnolence measured by Epworth scale
Anxiety and depression
Average change from baseline in anxiety and depression measured by Hospital Anxiety and Average change from baseline in anxiety and depression measured by Hospital ANxiety and Depression scale
Serious adverse reactions (SARs)
Probability of occurrence of SARs
drug consumption
change in drug consumption
non-drug treatment consumption
change in non-drug treatment consumption
Thermal outbreaks
Probability of occurrence of thermal outbreaks during the cure period
Fibromyalgia outbreaks
Probability of occurrence fibromyalgia outbreaks during remote follow-up
Full Information
NCT ID
NCT02406313
First Posted
March 25, 2015
Last Updated
November 13, 2018
Sponsor
Association Francaise pour la Recherche Thermale
1. Study Identification
Unique Protocol Identification Number
NCT02406313
Brief Title
Fibromyalgia Therapeutic Education in Thermal Cure
Acronym
FiETT
Official Title
Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (ETP), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (CTS) for fibromyalgia among patients continuing regular drug treatment or not
Detailed Description
Fibromyalgia is a poorly known and understood disease. Patients suffer from pain, fatigue, sleep disorders, anxiety, depression, preventing them from moving and going out, resulting in an alteration of social life. Multiple drugs treatment is frequently used but is burdensome and poorly effective. However, thermal cure proved efficacious to improve quality of life during the cure and beyond. This study aims at demonstrating the added value of a patient's therapeutic education program provided during a thermal cure, a moment where patients are available and receptive to guidance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTS + ETP
Arm Type
Experimental
Arm Description
Patients following a standardized thermal cure (CTS) follow an additional program called Fibr'eaux (ETP) that consists in discussion groups and physical activities allowing patients to learn how to manage their illness.
Arm Title
CTS alone
Arm Type
Active Comparator
Arm Description
Patients follow a standardized thermal cure that is a sedative, relaxing, antalgic and mobilizing treatment based on muds application, hydrotherapy and physiotherapy. The cure is made of 72 treatments selected among a list including muds application, massages, reeducation in thermal pool, baths and showers.
Intervention Type
Other
Intervention Name(s)
CTS
Intervention Description
Standardized Thermal Cure
Intervention Type
Other
Intervention Name(s)
ETP
Intervention Description
Patient Therapeutic Education
Primary Outcome Measure Information:
Title
Change in quality of life
Description
Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.
Time Frame
Month 06 after cure completion
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Time Frame
Week 03, Month 03, Month 12
Title
Responder rate
Description
Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Pain intensity
Description
Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Pain relief
Description
Average change from baseline in pain relief measured on a VAS
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Kinesiophobia index
Description
Average change from baseline in kinesiophobia measured by TAMPA scale
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Catastrophizing index
Description
Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Function impairment
Description
Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Fatigue
Description
Average change from baseline in fatigue measured by Picot scale
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Somnolence
Description
Average change from baseline in somnolence measured by Epworth scale
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Anxiety and depression
Description
Average change from baseline in anxiety and depression measured by Hospital Anxiety and Average change from baseline in anxiety and depression measured by Hospital ANxiety and Depression scale
Time Frame
Week 03, Month 03, Month 06, Month 12
Title
Serious adverse reactions (SARs)
Description
Probability of occurrence of SARs
Time Frame
Day 00 to Month 12
Title
drug consumption
Description
change in drug consumption
Time Frame
Day 00, Week 03, Month 03, Month 06, Month 12
Title
non-drug treatment consumption
Description
change in non-drug treatment consumption
Time Frame
Day 00, Week 03, Month 03, Month 06, Month 12
Title
Thermal outbreaks
Description
Probability of occurrence of thermal outbreaks during the cure period
Time Frame
Day 00 to Week 03
Title
Fibromyalgia outbreaks
Description
Probability of occurrence fibromyalgia outbreaks during remote follow-up
Time Frame
Week 03 to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Diagnostic of fibromyalgia done at least 6 months before thermal cure
Diagnostic of fibromyalgia confirmed by FIRST questionnaire (score 5) during the initial thermal checkup
Age between 18 and 65 years
Access to an Internet connection during remote follow-up
Affiliation to a social security system (recipient or assignee)
Signed written inform consent form
Exclusion Criteria
Infectious diseases with ongoing treatment (except for winter upper respiratory tract pathologies)
Active tumorous pathology
Concomitant inflammatory rheumatism
Stage III chronic venous insufficiency with history of phlebitis and/or pulmonary embolism
Incapacity to receive treatment in hot water ( ≥36°)
Total incapacity to practice physical activities of therapeutic education program
Ongoing pregnancy
Involvement in a structured educational program specific to fibromyalgia during the previous year
Incapacity to understand French language making the follow up impossible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DUCAMP, MD
Organizational Affiliation
Centre de Médecine et de Traumatologie du Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
OTD
City
Dax
State/Province
Aquitaine
ZIP/Postal Code
40180
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16777329
Citation
Diatchenko L, Nackley AG, Slade GD, Fillingim RB, Maixner W. Idiopathic pain disorders--pathways of vulnerability. Pain. 2006 Aug;123(3):226-230. doi: 10.1016/j.pain.2006.04.015. Epub 2006 Jun 13. No abstract available.
Results Reference
background
Citation
Branco JC, Saraiva F et al. Fibromyalgia Syndrom : A european epidemiological survey. Abstract Sat 0452 Eular 2005
Results Reference
background
PubMed Identifier
7818567
Citation
Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
Results Reference
background
Citation
Haute Autorité de Santé. Le syndrome fibromyalgique de l'adulte. Rapport d'orientation. Juillet 2010. 124p
Results Reference
background
Citation
Laroche F. Actualités de la fibromyalgie. Rev Rhum 2009;76:529-36.
Results Reference
background
Citation
Boureau F. Modèles théoriques cognitifs et comportementaux de la douleur chronique Doul et Analg 1999 ; 4 : 265-72
Results Reference
background
Citation
Vlaeyen JWS. Place du concept de " peur de bouger " (ré) apparition du " mal " dans l'analyse et la réhabilitation comportementale des lombalgiques chroniques. Doul et Analg, 1999 ; 4 :281-8
Results Reference
background
PubMed Identifier
11880847
Citation
Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.
Results Reference
background
Citation
Bannwarth B, Blotman F, Le Lay K, Boussetta S, Caubère JP, André E, Taïeb C. Prévalence of fibromyalgia : a large-scale european survey : results in France Eular 2008, Paris, THU0392
Results Reference
background
Citation
Maugars Y, Lamotte M, De Vos C C, Girard L, Caubère JP, André E, Le Lay K, Taïeb C. Fibromyalgia : the avoied cost of the non-diagnosed patient in France. Eular 2008, Paris, THU0386
Results Reference
background
Citation
Boureau F. in Pratique du Traitement de la Douleur. Doin ed. 1988, 402p
Results Reference
background
PubMed Identifier
9638897
Citation
Weigent DA, Bradley LA, Blalock JE, Alarcon GS. Current concepts in the pathophysiology of abnormal pain perception in fibromyalgia. Am J Med Sci. 1998 Jun;315(6):405-12. doi: 10.1097/00000441-199806000-00009.
Results Reference
background
PubMed Identifier
7612042
Citation
Mountz JM, Bradley LA, Modell JG, Alexander RW, Triana-Alexander M, Aaron LA, Stewart KE, Alarcon GS, Mountz JD. Fibromyalgia in women. Abnormalities of regional cerebral blood flow in the thalamus and the caudate nucleus are associated with low pain threshold levels. Arthritis Rheum. 1995 Jul;38(7):926-38. doi: 10.1002/art.1780380708.
Results Reference
background
PubMed Identifier
7824761
Citation
Valverde O, Mico JA, Maldonado R, Mellado M, Gibert-Rahola J. Participation of opioid and monoaminergic mechanisms on the antinociceptive effect induced by tricyclic antidepressants in two behavioural pain tests in mice. Prog Neuropsychopharmacol Biol Psychiatry. 1994 Oct;18(6):1073-92. doi: 10.1016/0278-5846(94)90132-5.
Results Reference
background
Citation
Van Houdenove B, Luyten P. Fibromyalgia and related syndromes characterised by stress intolerance and pain hypersensitivity: do we need a new nosology ? Curr Rheumatol Rev 2007; 3: 304-308
Results Reference
background
Citation
Marchand S. Influences des hormones sexuelles sur les mécanismes endogens impliqués dans le développement et la persistance de la douleur. Congrès SFETD, Nantes, 2006, Douleurs, nov.2006, CS04
Results Reference
background
PubMed Identifier
17133252
Citation
Ablin JN, Cohen H, Buskila D. Mechanisms of Disease: genetics of fibromyalgia. Nat Clin Pract Rheumatol. 2006 Dec;2(12):671-8. doi: 10.1038/ncprheum0349.
Results Reference
background
Citation
Houvenagel E. Physiopathologie de la douleur de la fibromyalgie. Rev.Rhum.70(2003) :314-320
Results Reference
background
PubMed Identifier
12734906
Citation
Perrot S, Dumont D, Guillemin F, Pouchot J, Coste J; French Group for Quality of Life Research. Quality of life in women with fibromyalgia syndrome: validation of the QIF, the French version of the fibromyalgia impact questionnaire. J Rheumatol. 2003 May;30(5):1054-9.
Results Reference
background
Citation
Mothe B, Etude comparée de l'efficacité thérapeutique de l'hypnose et de la relaxation dans la fibromyalgie. Universite de Paris VIII - Vincennes - Saint-Denis. Ecole Doctorale Cognition Langage Interaction. Laboratoire de
Results Reference
background
PubMed Identifier
2053091
Citation
Gerin P, Dazord A, Cialdella P, Leizorovicz A, Boissel JP. [The questionnaire "Profile of the subjective quality of life". First data of validation]. Therapie. 1991 Mar-Apr;46(2):131-8. French.
Results Reference
background
Citation
Mailhan L. (2005). Qualité de vie après traumatisme crânien sévère. Pratiques psychologiques, 11, 343-357
Results Reference
background
Citation
Dazord A, Mercier C, Manificat S, Nicolas J. (1995), Evaluation de la qualité de la vie : mise au point d'un instrument d'évaluation dans un contexte francophone, Revue Européenne de Psychologie Appliquée, 45, 4, 271-278
Results Reference
background
Citation
Geenen R. Psychological approaches to management of fibromyalgia. Eular 2008, Paris, SP0124
Results Reference
background
PubMed Identifier
16078356
Citation
Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21. Erratum In: J Rheumatol Suppl. 2005 Oct;32(10):2063.
Results Reference
background
Citation
Coichard CG, Cabane J et al.Intérêt d'une prise en charge multidisciplinaire du patient fibromyalgique. Rev.Rhum. (2003) ; 70 :354-7
Results Reference
background
PubMed Identifier
14962965
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. doi: 10.1136/ard.2002.004945.
Results Reference
background
PubMed Identifier
3535811
Citation
Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986 Nov;29(11):1371-7. doi: 10.1002/art.1780291110.
Results Reference
background
Citation
Miadsi D, Juniper MD. et al. The pharmacological management of fibromyalgia syndrome in the UK primary care setting. Eular, 2008, Paris. OP0076
Results Reference
background
PubMed Identifier
19078481
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. doi: 10.1097/00124743-200010000-00004.
Results Reference
background
PubMed Identifier
9604730
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.
Results Reference
background
PubMed Identifier
12753877
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. doi: 10.1016/s0002-9343(03)00116-5.
Results Reference
background
PubMed Identifier
8610220
Citation
Sorensen J, Bengtsson A, Backman E, Henriksson KG, Bengtsson M. Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol. 1995;24(6):360-5. doi: 10.3109/03009749509095181.
Results Reference
background
Citation
Trèves R, Bannwarth B, Bertin P, Javier RM, Glowinski J, Le Bars M, Perrot S. Les Recommandations de Limoges. Usage de la morphine dans les douleurs rhumatismales non cancéreuses. Douleurs, 2000, 1,1, 33-38
Results Reference
background
PubMed Identifier
176677
Citation
Moldofsky H, Scarisbrick P. Induction of neurasthenic musculoskeletal pain syndrome by selective sleep stage deprivation. Psychosom Med. 1976 Jan-Feb;38(1):35-44. doi: 10.1097/00006842-197601000-00006.
Results Reference
background
PubMed Identifier
16762044
Citation
Arnold LM. Biology and therapy of fibromyalgia. New therapies in fibromyalgia. Arthritis Res Ther. 2006;8(4):212. doi: 10.1186/ar1971.
Results Reference
background
PubMed Identifier
2672134
Citation
Goldenberg DL. Management of fibromyalgia syndrome. Rheum Dis Clin North Am. 1989 Aug;15(3):499-512.
Results Reference
background
PubMed Identifier
14872449
Citation
Tofferi JK, Jackson JL, O'Malley PG. Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis. Arthritis Rheum. 2004 Feb 15;51(1):9-13. doi: 10.1002/art.20076.
Results Reference
background
PubMed Identifier
7973479
Citation
Wolfe F, Cathey MA, Hawley DJ. A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand J Rheumatol. 1994;23(5):255-9. doi: 10.3109/03009749409103725.
Results Reference
background
PubMed Identifier
11893345
Citation
Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med. 2002 Feb 15;112(3):191-7. doi: 10.1016/s0002-9343(01)01089-0.
Results Reference
background
PubMed Identifier
10833553
Citation
Anderberg UM, Marteinsdottir I, von Knorring L. Citalopram in patients with fibromyalgia--a randomized, double-blind, placebo-controlled study. Eur J Pain. 2000;4(1):27-35. doi: 10.1053/eujp.1999.0148.
Results Reference
background
PubMed Identifier
11029681
Citation
O'Malley PG, Balden E, Tomkins G, Santoro J, Kroenke K, Jackson JL. Treatment of fibromyalgia with antidepressants: a meta-analysis. J Gen Intern Med. 2000 Sep;15(9):659-66. doi: 10.1046/j.1525-1497.2000.06279.x.
Results Reference
background
PubMed Identifier
10749947
Citation
Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics. 2000 Mar-Apr;41(2):104-13. doi: 10.1176/appi.psy.41.2.104.
Results Reference
background
PubMed Identifier
20002596
Citation
Goldenberg DL, Clauw DJ, Palmer RH, Mease P, Chen W, Gendreau RM. Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. Pain Med. 2010 Feb;11(2):180-94. doi: 10.1111/j.1526-4637.2009.00755.x. Epub 2009 Dec 9.
Results Reference
background
Citation
Branco JC, Perrot S, Bragee G, Zachrisson O, Mikkelsen K, Mainguy Y, Pezous N. Milnacipran for the treatment of fibromyalgia syndrome : a European multicenter, randomized, double-blind, placebo-controlled trial. Eular 2008, Paris, THU0365
Results Reference
background
PubMed Identifier
19454869
Citation
Chappell AS, Littlejohn G, Kajdasz DK, Scheinberg M, D'Souza DN, Moldofsky H. A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. Clin J Pain. 2009 Jun;25(5):365-75. doi: 10.1097/AJP.0b013e31819be587.
Results Reference
background
PubMed Identifier
18395345
Citation
Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.
Results Reference
background
Citation
Zijlstra TR, Barendregt PJ, van De Laar MA. Venlafaxine in fibromyalgia: results of a randomized placebo-controlled, double-blind trial. Arthritis Rheum. 2002;46:S105
Results Reference
background
Citation
Clère F, Henry F, Perriot M. Quelle place pour le clonazepam dans la douleur chronique ? Douleurs, vol7n°6 dec 2006 :314-317
Results Reference
background
PubMed Identifier
17393438
Citation
Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44. doi: 10.1002/art.22457.
Results Reference
background
PubMed Identifier
15818684
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. doi: 10.1002/art.20983.
Results Reference
background
PubMed Identifier
18028041
Citation
Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma U. The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Pain Med. 2007 Nov-Dec;8(8):633-8. doi: 10.1111/j.1526-4637.2007.00332.x.
Results Reference
background
Citation
Barrett J, Russell J, Pauer L, Whalen E, Leon T, Zeiher B. The effect of pregabalin treatment on changes in pain and sleep quality in fibromyalgia patients.Eular 2008, Paris, THU0362
Results Reference
background
Citation
Arkfeld DG, Setoodeh KM, Abrahim J, Cole SE, Metyas S. The inability of most us patients to tolerate the recommended doses of pregabalin in the treatment of fibromyalgia ;: a case study. Elar 2008, Paris, THU0396
Results Reference
background
PubMed Identifier
17610577
Citation
Wood PB, Schweinhardt P, Jaeger E, Dagher A, Hakyemez H, Rabiner EA, Bushnell MC, Chizh BA. Fibromyalgia patients show an abnormal dopamine response to pain. Eur J Neurosci. 2007 Jun;25(12):3576-82. doi: 10.1111/j.1460-9568.2007.05623.x.
Results Reference
background
PubMed Identifier
16052595
Citation
Holman AJ, Myers RR. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum. 2005 Aug;52(8):2495-505. doi: 10.1002/art.21191.
Results Reference
background
PubMed Identifier
9552084
Citation
Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31. doi: 10.1016/s0002-9343(97)00351-3.
Results Reference
background
PubMed Identifier
3910836
Citation
Clark S, Tindall E, Bennett RM. A double blind crossover trial of prednisone versus placebo in the treatment of fibrositis. J Rheumatol. 1985 Oct;12(5):980-3.
Results Reference
background
Citation
Russell u, Bennett RM, Michalek JE. Sodium oxybrate relieves pain and improves sleep in fibromyalgia syndrome. A randomized, double-blind, placebo-controlled, multi-center clinical trial. ACR/ARHP Scientific Meeting. 2005; programm book supplement:late-breaking abstracts
Results Reference
background
PubMed Identifier
12849718
Citation
Holdcraft LC, Assefi N, Buchwald D. Complementary and alternative medicine in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):667-83. doi: 10.1016/s1521-6942(03)00037-8.
Results Reference
background
PubMed Identifier
16454724
Citation
Sarac AJ, Gur A. Complementary and alternative medical therapies in fibromyalgia. Curr Pharm Des. 2006;12(1):47-57.
Results Reference
background
PubMed Identifier
16490727
Citation
Perrot S, Maheu E, Javier RM, Eschalier A, Coutaux A, LeBars M, Bertin P, Bannwarth B, Treves R. Guidelines for the use of antidepressants in painful rheumatic conditions. Eur J Pain. 2006 Apr;10(3):185-92. doi: 10.1016/j.ejpain.2005.03.004. Epub 2005 Apr 18.
Results Reference
background
Citation
Journal Officiel de la République Française, 9 août 2006. Arrêté du 1er août 2006 portant approbation d'un avenant à la convention nationale thermale.
Results Reference
background
Citation
Thermalisme et santé publique vers de nouvelles convergences. Livre Blanc CNETH 2008.
Results Reference
background
Citation
Rapport 2011 du Conseil National du Tourisme pour le Ministre chargé du Tourisme " réflexions et propositions sur la diversification des stationsThermales ".
Results Reference
background
PubMed Identifier
10450540
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.
Results Reference
background
PubMed Identifier
15639063
Citation
Adler GK, Geenen R. Hypothalamic-pituitary-adrenal and autonomic nervous system functioning in fibromyalgia. Rheum Dis Clin North Am. 2005 Feb;31(1):187-202, xi. doi: 10.1016/j.rdc.2004.10.002.
Results Reference
background
PubMed Identifier
16258904
Citation
McLean SA, Williams DA, Harris RE, Kop WJ, Groner KH, Ambrose K, Lyden AK, Gracely RH, Crofford LJ, Geisser ME, Sen A, Biswas P, Clauw DJ. Momentary relationship between cortisol secretion and symptoms in patients with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3660-9. doi: 10.1002/art.21372.
Results Reference
background
PubMed Identifier
15965635
Citation
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.
Results Reference
background
PubMed Identifier
15695301
Citation
Zijlstra TR, van de Laar MA, Bernelot Moens HJ, Taal E, Zakraoui L, Rasker JJ. Spa treatment for primary fibromyalgia syndrome: a combination of thalassotherapy, exercise and patient education improves symptoms and quality of life. Rheumatology (Oxford). 2005 Apr;44(4):539-46. doi: 10.1093/rheumatology/keh537. Epub 2005 Feb 3.
Results Reference
background
PubMed Identifier
17520260
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. doi: 10.1007/s00296-007-0358-x. Epub 2007 May 23.
Results Reference
background
Citation
C. Robert, Fibromyalgie et cures thermales. Journée d'Automne de l'Institut du thermalisme Dax 27/11/2009
Results Reference
background
PubMed Identifier
17644548
Citation
Carville SF, Arendt-Nielsen L, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsoe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Spath M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. doi: 10.1136/ard.2007.071522. Epub 2007 Jul 20. Erratum In: Ann Rheum Dis. 2015 Feb;74(2):476. Arendt-Nielsen, S [corrected to Arendt-Nielsen, L].
Results Reference
background
Citation
Simon D, Traynard PY, Bourdillon F, Gagnaire R, Grimaldi A. Education thérapeutique, prévention et maladies chroniques. Masson. 2ème édition 2011.
Results Reference
background
Citation
Résultats de l'étude TNS Healthcare auprès de 112 000 curistes 2006 source CNETH 1 rue Cels 75016 Paris.
Results Reference
background
Citation
Ducamp Ph.Le thermalisme peut-il être le lieu idéal de la prise en charge des patients fibromyalgiques ? Mémoire de fin d'études du diplôme universitaire d'éducation thérapeutique de formation et de coordination d'équipe. UMFMC Université Bordeaux Segalen 2012.
Results Reference
background
Citation
Ducamp Ph. Journées Nationales du thermalisme Luchon Nov 2012. La place des médecins thermaux dans l'éducation thérapeutique.
Results Reference
background
Citation
Haute Autorité de Santé. Guide méthodologique
Results Reference
background
Citation
Sichère P. Fibromyalgie, éducation thérapeutique, thermalisme. Mémoire de fin d'études et de formation à l'éducation thérapeutique IPCEM. IPCEM 2012.
Results Reference
background
Citation
Sichère P, Ducamp P. Fibromyalgie, éducation thérapeutique, thermalisme. Congrès national de la Société Française de Rhumatologie (M149) Paris 8-12 décembre 2012.
Results Reference
background
Citation
Ducamp Ph. Fibromyalgie, éducation thérapeutique et thermalisme. La presse thermale et climatique, Nov 2011.
Results Reference
background
Citation
Sichère P. Evaluation, diagnostics, traitements. Douleurs 2012; 13: 244-6: Douleurs et thermalisme: questions posées au Dr Philippe Ducamp.
Results Reference
background
Citation
Sichère P et Ducamp P. Éducation thérapeutique, fibromyalgie et thermalisme. Douleurs 2013; 14: 22-9.
Results Reference
background
Citation
Françon A, Queneau P. Quelle place pour la crénothérapie dans la fibromyalgie ? Abrégé " Médecine thermale. Faits et preuves ". P. Queneau et coll. Edition Masson 2000, p 75-77
Results Reference
background
Citation
Françon A. Fibromyalgie et thermalisme. N°125-14-janvier 2010-reflexions Rhumato.p15-18
Results Reference
background
Citation
D'Ivernois JF, Gagnayre R. Propositions pour l'évaluation de l'éducation thérapeutique. In ADSP, n°58, mars 2007
Results Reference
background
Citation
Foucaud J, Bury JA, Balcou-Debussche M, Eymard C. Education thérapeutique du patient : Modèles, pratiques et évaluation. Dir. Saint Denis INPES, collection Santé en Action, 2010 : 412p.
Results Reference
background
Citation
Roberts PJ, Torgerson DJ, BMJ 2002
Results Reference
background
PubMed Identifier
20488620
Citation
Perrot S, Bouhassira D, Fermanian J; CEDR (Cercle d'Etude de la Douleur en Rhumatologie). Development and validation of the Fibromyalgia Rapid Screening Tool (FiRST). Pain. 2010 Aug;150(2):250-256. doi: 10.1016/j.pain.2010.03.034. Epub 2010 May 21.
Results Reference
background
Citation
Huet AG. Une expérience d'Art-Thérapie, à dominante danse, auprès des personnes fibromyalgiques. Université François Rabelais ; UFR médecine Tours. 2011.
Results Reference
background
Citation
Graber-Duvernay B. Dix ans de surveillance épidémiologique des pneumopathies à Aix-les-Bains (1990 - 1999). Presse Therm Clim 2001; 138: 13-25
Results Reference
background
Citation
Gerbaud L, Maire A, Devaux I, Chadès C, Riguidel Ph, Vidal A, Glanddier Ph Y. La surveillance des incidents infectieux chez les curistes thermaux en auvergne synthèse de 8 années d'expérience de réseaux sentinelles. Presse Therm Clim 2001; 138: 41-50
Results Reference
background
Citation
Fournet D. La surveillance des incidents infectieux chez les curistes de Balaruc-les-Bains. Presse Therm Clim 2001; 138: 51-53
Results Reference
background
Citation
Françon A, Graber-Duvernay B, Forestier R, Palmer M. Incidence des évènements infectieux dans une population de curistes présumés vulnérables. Presse Therm Clim 2001; 138: 55-65
Results Reference
background
Citation
Leclerc H. Bactériologie de Pseudomonas aeruginosa. Presse Therm Clim 2002; 139: 9-13
Results Reference
background
Citation
Ruimy R. Pathogénicité de Pseudomonas aeruginosa en dehors de la mucoviscidose. Presse Therm Clim 2002; 139: 15-21
Results Reference
background
Citation
Tancréde-Bohin E. Pseudomonas et infections cutanées. Presse Therm Clim 2002; 139: 23-28
Results Reference
background
Citation
Barry B. Pseudomonas aeruginosa et infections ORL. Presse Therm Clim 2002; 139: 29-33
Results Reference
background
Citation
Graber-Duvernay B. Pseudomonas aeruginosa et infections broncho-pulmonaires. Presse Therm Clim 2002; 139: 35-40
Results Reference
background
Citation
Morin J.P, Graber-Duvernay B. Surveillance des pseudomonas et expériences de désinfection. Presse Therm Clim 2002; 139: 41-51
Results Reference
background
Citation
Hartemann Ph. Quelles mesures préconiser pour une gestion raisonnée du risque dû a Pseudomonas aeruginosa ? Presse therm climat 2002; 139: 53-57
Results Reference
background
Citation
Nguyen Ba B, Dubourg K, Pécastaings S, Optimisation de la lutte contre les légionnelles et autres opportunistes dans les réseaux d'eau minérale naturelle, grâce à un pilote "eau thermale". Press Therm Clim 2006;143:7-123
Results Reference
background
Citation
R Forestier, A Françon, Graber-Duvernay B, Palmer M, sevez JF, Guillemot A, BErnard JP, Souchon JF, Gerrud S, Le Provost C, Joly J, Rogeaux O, Deschamps O. Incidence des événements infectieux survenus en cure thermale dans une population de curistes présu- més vulnérables : étude contrôlée longitudinale sur 738 patients. Press Therm Clim 2008;145:9-21
Results Reference
background
Citation
Dubourg K, Grégoire P, Lagière J. La désinfection des piscines thermales de Dax. Press Therm Clim 2008;145:61-71
Results Reference
background
Citation
Ducamp P. Fibromyalgie et thermalisme. 10ème Congrès National de la Fibromyalgie FNAFF. Nîmes, 13 octobre 2012.
Results Reference
background
Citation
Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles
Results Reference
background
Citation
Sous-groupe de travail Qualité de la promotion - Plan de monitoring adapté - DRCI Hospices Civils de Lyon. Elaboration du plan de monitoring adapté pour une recherche biomédicale à promotion institutionnelle
Results Reference
background
PubMed Identifier
19369473
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.
Results Reference
background
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