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

January 10, 2019 updated by: Association Francaise pour la Recherche Thermale

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix les Bains, France, 73100
        • station thermale AIX LES BAINS
      • Allevard, France, 38580
        • station thermale ALLEVARD LES BAINS
      • Bourbon-Lancy, France, 71140
        • station thermale BOURBON LANCY
      • Lamalou les Bains, France, 34240
        • station thermale LAMALOU LES BAINS
      • Uriage les bains, France, 38410
        • Station thermale URIAGE LES BAINS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Spa treatment after 6 months visit in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handicap in everyday life
Time Frame: 6 months
Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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.
at baseline, 3, 6, 9 and 12 months
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
at baseline, 3, 6, 9 and 12 months
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
at baseline, 3, 6, 9 and 12 months
Fatigue
Time Frame: at baseline, 3, 6, 9 and 12 months
Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months
at baseline, 3, 6, 9 and 12 months
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
at baseline, 3, 6, 9 and 12 months
Ability to cope
Time Frame: at baseline, 6 and 12 months
Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months
at baseline, 6 and 12 months
Physical activity
Time Frame: 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
at baseline, 3, 6, 9 and 12 months
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.
at baseline, 3, 6, 9 and 12 months
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
at baseline, 3, and 6 months
Objective sleep quality
Time Frame: at baseline, 3, and 6 months
Record of night activity and cardiac variability at baseline, 3 and 6 months
at baseline, 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise pour la Recherche Thermale

Collaborators

University Hospital, Grenoble
Floralis

Investigators

  • Principal Investigator: Caroline MAINDET DOMINICI, MD, Hospital University Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC/13/68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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