Trial record 17 of 92 for:    fibromyalgia | Open Studies | Exclude Unknown

Evaluation of Spa Therapy in the Treatment of Fibromyalgia (THERMALGI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Association Francaise pour la Recherche Thermale
Sponsor:
Collaborators:
Floralis
University Hospital, Grenoble
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT02265029
First received: October 9, 2014
Last updated: March 5, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Rheumatism, Muscular
Other: Immediate spa treatment
Other: Late spa treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:
  • Handicap in everyday life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline


Secondary Outcome Measures:
  • Quality of life [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    1. Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome.
    2. EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months.
    3. Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.

  • Pain evolution [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months

  • Sleep quality [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months

  • Fatigue [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months

  • Depression [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months

  • Physical activity [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    1. Evolution of Baecke score between baseline, 6 and 12 months
    2. evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months

  • Medico economic impact [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.

  • Objective physical activity [ Time Frame: at baseline, 3, and 6 months ] [ Designated as safety issue: No ]
    Record of day activity during one week with actigraphy at baseline, 3 and 6 months

  • Objective sleep quality [ Time Frame: at baseline, 3, and 6 months ] [ Designated as safety issue: No ]
    Record of night activity and cardiac variability at baseline, 3 and 6 months


Estimated Enrollment: 220
Study Start Date: September 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate spa treatment
Spa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)
Other: Immediate spa treatment
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Other Name: Spa treatment soon after randomisation
Sham Comparator: Late SPA treatment
Spa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)
Other: Late spa treatment
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Other Name: Spa treatment after 6 months visit in the study

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02265029

Contacts
Contact: Carole ROLLAND 33 4 76 76 50 40 CarRolland@chu-grenoble.fr
Contact: Vanessa GRIMAUD 33 4 76 76 66 39 VGrimaud@chu-grenoble.fr

Locations
France
station thermale AIX LES BAINS Not yet recruiting
Aix les Bains, France, 73100
Principal Investigator: Alain FRANCON, MD         
Principal Investigator: Romain FORESTIER, MD         
station thermale ALLEVARD LES BAINS Recruiting
Allevard, France, 38580
Contact: Claire CRACOWSKI, MD    33 4 76 76 92 60    CCracowski@chu-grenoble.fr   
Principal Investigator: Caroline MAINDET DOMINICI, MD         
Sub-Investigator: Claire CRACOWSKI, MD         
Sub-Investigator: Jean-Luc CRACOWSKI, MD         
Sub-Investigator: Anne DUMOLARD, MD         
Sub-Investigator: Olivier VERDURAND, MD         
station thermale BOURBON LANCY Not yet recruiting
Bourbon-Lancy, France, 71140
station thermale LAMALOU LES BAINS Not yet recruiting
Lamalou les Bains, France, 34240
Station thermale URIAGE LES BAINS Not yet recruiting
Uriage, France, 38410
Contact: Caroline MAINDET DOMINICI, MD    33 4 76 76 92 60    CMaindetDominici@chu-grenoble.fr   
Principal Investigator: Caroline MAINDET DOMINICI, MD         
Sub-Investigator: Claire CRACOWSKI, MD         
Sub-Investigator: Jean-Luc CRACOWSKI, MD         
Sub-Investigator: Anne DUMOLARD, MD         
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Floralis
University Hospital, Grenoble
Investigators
Principal Investigator: Caroline MAINDET DOMINICI, MD Hospital University Grenoble
  More Information

Publications:

Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT02265029     History of Changes
Other Study ID Numbers: DCIC/13/68
Study First Received: October 9, 2014
Last Updated: March 5, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins
France: Commission nationale de l'informatique et des libertés

Keywords provided by Association Francaise pour la Recherche Thermale:
fibromyalgia
rheumatism
fatigue syndrom
pain
spa treatment in rheumatology

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Rheumatic Diseases
Connective Tissue Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 23, 2015