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FibromyalgiaFiETTNCT02406313

Fibromyalgia Therapeutic Education in Thermal Cure

A study testing CTS and ETP in people with Fibromyalgia, run by Association Francaise pour la Recherche Thermale at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia
What is being tested?
CTS and ETP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteFrance
Study dates
Mar 2015to 31 Dec 2018
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

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • OTD

    Dax, Aquitaine, 40180

Other trials in France

About this study

Official title: Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

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

Read the 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.

Conditions
Fibromyalgia
Being tested
CTS, ETP
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTSOther

    Standardized Thermal Cure

  • ETPOther

    Patient Therapeutic Education

Study groups in NCT02406313
Study groupRoleWhat they receive
CTS + ETPExperimentalPatients 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.
Receives: Other: CTS; Other: ETP
CTS aloneActive comparatorPatients 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.
Receives: Other: CTS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 06 after cure completion

Secondary outcomes (15)

  1. Change in quality of life

    Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)

    Measured: Week 03, Month 03, Month 12

  2. Responder rate

    Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00

    Measured: Week 03, Month 03, Month 06, Month 12

  3. Pain intensity

    Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)

    Measured: Week 03, Month 03, Month 06, Month 12

  4. Pain relief

    Average change from baseline in pain relief measured on a VAS

    Measured: Week 03, Month 03, Month 06, Month 12

  5. Kinesiophobia index

    Average change from baseline in kinesiophobia measured by TAMPA scale

    Measured: Week 03, Month 03, Month 06, Month 12

  6. Catastrophizing index

    Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)

    Measured: Week 03, Month 03, Month 06, Month 12

  7. Function impairment

    Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale

    Measured: Week 03, Month 03, Month 06, Month 12

  8. Fatigue

    Average change from baseline in fatigue measured by Picot scale

    Measured: Week 03, Month 03, Month 06, Month 12

  9. Somnolence

    Average change from baseline in somnolence measured by Epworth scale

    Measured: Week 03, Month 03, Month 06, Month 12

  10. 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

    Measured: Week 03, Month 03, Month 06, Month 12

  11. Serious adverse reactions (SARs)

    Probability of occurrence of SARs

    Measured: Day 00 to Month 12

  12. drug consumption

    change in drug consumption

    Measured: Day 00, Week 03, Month 03, Month 06, Month 12

  13. non-drug treatment consumption

    change in non-drug treatment consumption

    Measured: Day 00, Week 03, Month 03, Month 06, Month 12

  14. Thermal outbreaks

    Probability of occurrence of thermal outbreaks during the cure period

    Measured: Day 00 to Week 03

  15. Fibromyalgia outbreaks

    Probability of occurrence fibromyalgia outbreaks during remote follow-up

    Measured: Week 03 to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionSep 2017
  4. Study completion31 Dec 2018 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406313
Sponsor's protocol ID
2014-A00464-43
Acronym
FiETT
Status last verified
Jun 2018
First submitted
25 Mar 2015
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16777329

  • Branco JC, Saraiva F et al. Fibromyalgia Syndrom : A european epidemiological survey. Abstract Sat 0452 Eular 2005

  • 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.

    PubMed 7818567

  • Haute Autorité de Santé. Le syndrome fibromyalgique de l'adulte. Rapport d'orientation. Juillet 2010. 124p

  • Laroche F. Actualités de la fibromyalgie. Rev Rhum 2009;76:529-36.

  • Boureau F. Modèles théoriques cognitifs et comportementaux de la douleur chronique Doul et Analg 1999 ; 4 : 265-72

  • 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

  • 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.

    PubMed 11880847

  • 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

  • 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

  • Boureau F. in Pratique du Traitement de la Douleur. Doin ed. 1988, 402p

  • 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.

    PubMed 9638897

  • 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.

    PubMed 7612042

  • 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.

    PubMed 7824761

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing CTS and ETP in people with Fibromyalgia, run by Association Francaise pour la Recherche Thermale at 1 site in France.

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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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 France. 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. 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?

Results are not available in the source record.

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 in quality of life (time frame: Month 06 after cure completion). 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 NCT02406313, which also lists 108 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 14 Nov 2018.

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