Evaluation of Spa Therapy in the Treatment of Fibromyalgia

NCT02265029 | Completed DMC

• 1 other identifier: DCIC/13/68
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

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.

Conditions

Fibromyalgia; Rheumatism, Muscular

Keywords

fibromyalgia; rheumatism; fatigue syndrom; pain; spa treatment in rheumatology

Outcome Measures

Primary Outcomes (1)

• Handicap in everyday life

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

  6 months

Secondary Outcomes (10)

• Quality of life

  at baseline, 3, 6, 9 and 12 months

• Pain evolution

  at baseline, 3, 6, 9 and 12 months

• Sleep quality

  at baseline, 3, 6, 9 and 12 months

• Fatigue

  at baseline, 3, 6, 9 and 12 months

• Depression

  at baseline, 3, 6, 9 and 12 months

Study Arms (2)

Immediate spa treatment

ACTIVE COMPARATOR

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

Late SPA treatment

SHAM COMPARATOR

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

Interventions

Immediate spa treatment OTHER

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

Also known as: Spa treatment soon after randomisation

Immediate spa treatment

Late spa treatment OTHER

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

Also known as: Spa treatment after 6 months visit in the study

Late SPA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
• 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

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Floralis: collaborator
• University Hospital, Grenoble: collaborator

Study Sites (5)

station thermale AIX LES BAINS

Aix-les-Bains, 73100, France

Location

station thermale ALLEVARD LES BAINS

Allevard, 38580, France

Location

station thermale BOURBON LANCY

Bourbon-Lancy, 71140, France

Location

station thermale LAMALOU LES BAINS

Lamalou-les-Bains, 34240, France

Location

Station thermale URIAGE LES BAINS

Uriage-les-Bains, 38410, France

Location

Related Publications (53)

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• Maindet C, Maire A, Vermorel C, Cracowski C, Rolland C, Forestier R, Comte A, Roques CF, Serra E, Bosson JL. Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial. J Pain. 2021 Aug;22(8):940-951. doi: 10.1016/j.jpain.2021.02.010. Epub 2021 Mar 4.

  PMID: 33677113 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Rheumatic Diseases; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline MAINDET DOMINICI, MD

  Hospital University Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: March 30, 2018
• Study Completion: October 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (5)