Evaluation of Spa Therapy in the Treatment of Fibromyalgia

NCT ID: NCT02265029

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-10-31

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.

Conditions

Fibromyalgia; Rheumatism, Muscular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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,...)

Group Type: ACTIVE_COMPARATOR

Immediate spa treatment

Intervention Type: OTHER

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

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,...)

Group Type: SHAM_COMPARATOR

Late spa treatment

Intervention Type: OTHER

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

Interventions

Immediate spa treatment

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

Intervention Type: OTHER

Late spa treatment

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

Intervention Type: OTHER

Other Intervention Names

Spa treatment soon after randomisation; Spa treatment after 6 months visit in the study

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Floralis

INDUSTRY

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline MAINDET DOMINICI, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Grenoble

Locations

station thermale AIX LES BAINS

Aix-les-Bains, , France

station thermale ALLEVARD LES BAINS

Allevard, , France

station thermale BOURBON LANCY

Bourbon-Lancy, , France

station thermale LAMALOU LES BAINS

Lamalou-les-Bains, , France

Station thermale URIAGE LES BAINS

Uriage-les-Bains, , France

Countries

France

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Other Identifiers

DCIC/13/68

Identifier Type: -

Identifier Source: org_study_id