Fibromyalgia, Rheumatism, Muscular
Conditions
Keywords
fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology
Brief 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.
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.
Interventions
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
OTHERLate spa treatment
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Sponsors
Floralis
University Hospital, Grenoble
Association Francaise pour la Recherche Thermale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handicap in everyday life | 6 months | Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | at baseline, 3, 6, 9 and 12 months | 1. Evolution of Baecke score between baseline, 3, 6, 9 and 12 months 2. evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months |
| Quality of life | at baseline, 3, 6, 9 and 12 months | 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 | at baseline, 3, 6, 9 and 12 months | Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months |
| Sleep quality | at baseline, 3, 6, 9 and 12 months | Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months |
| Ability to cope | at baseline, 6 and 12 months | Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months |
| Depression | at baseline, 3, 6, 9 and 12 months | Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months |
| Medico economic impact | at baseline, 3, 6, 9 and 12 months | Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort. |
| Objective physical activity | at baseline, 3, and 6 months | Record of day activity during one week with actigraphy at baseline, 3 and 6 months |
| Objective sleep quality | at baseline, 3, and 6 months | Record of night activity and cardiac variability at baseline, 3 and 6 months |
| Fatigue | at baseline, 3, 6, 9 and 12 months | Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months |
Countries
France
Outcome results
None listed