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NCT Number: NCT02265029

Evaluation of Spa Therapy in the Treatment of Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatism, Muscular Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

station thermale AIX LES BAINS, Aix-les-Bains, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate spa treatment

Other

spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)

Other names: Spa treatment soon after randomisation

Late spa treatment

Other

spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)

Other names: Spa treatment after 6 months visit in the study

Primary outcomes

  1. Handicap in everyday life

    Time frame: 6 months

    Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline

Secondary outcomes

  1. Quality of life

    Time frame: at baseline, 3, 6, 9 and 12 months

    • 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.

  2. Pain evolution

    Time frame: 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

  3. Sleep quality

    Time frame: 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

  4. Fatigue

    Time frame: at baseline, 3, 6, 9 and 12 months

    Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months

  5. Depression

    Time frame: 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

  6. Ability to cope

    Time frame: at baseline, 6 and 12 months

    Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months

  7. Physical activity

    Time frame: at baseline, 3, 6, 9 and 12 months

    • 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

  8. Medico economic impact

    Time frame: at baseline, 3, 6, 9 and 12 months

    Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.

  9. Objective physical activity

    Time frame: at baseline, 3, and 6 months

    Record of day activity during one week with actigraphy at baseline, 3 and 6 months

  10. Objective sleep quality

    Time frame: at baseline, 3, and 6 months

    Record of night activity and cardiac variability at baseline, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Association Francaise pour la Recherche Thermale

Other

Collaborators

  • Floralis
  • University Hospital, Grenoble

Registry information

Official study title

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

Acronym: THERMALGI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2014
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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