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

Primary Purpose

Fibromyalgia, Rheumatism, Muscular

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate spa treatment
Late spa treatment
Sponsored by
Association Francaise pour la Recherche Thermale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • station thermale AIX LES BAINS
  • station thermale ALLEVARD LES BAINS
  • station thermale BOURBON LANCY
  • station thermale LAMALOU LES BAINS
  • Station thermale URIAGE LES BAINS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Immediate spa treatment

Late SPA treatment

Arm Description

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,...)

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,...)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life
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.
Pain evolution
Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months
Sleep quality
Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months
Fatigue
Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months
Depression
Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months
Ability to cope
Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months
Physical activity
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
Medico economic impact
Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.
Objective physical activity
Record of day activity during one week with actigraphy at baseline, 3 and 6 months
Objective sleep quality
Record of night activity and cardiac variability at baseline, 3 and 6 months

Full Information

First Posted
October 9, 2014
Last Updated
January 10, 2019
Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis, University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02265029
Brief Title
Evaluation of Spa Therapy in the Treatment of Fibromyalgia
Acronym
THERMALGI
Official Title
Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis, University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Rheumatism, Muscular
Keywords
fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate spa treatment
Arm Type
Active Comparator
Arm Description
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,...)
Arm Title
Late SPA treatment
Arm Type
Sham Comparator
Arm Description
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,...)
Intervention Type
Other
Intervention Name(s)
Immediate spa treatment
Other Intervention Name(s)
Spa treatment soon after randomisation
Intervention Description
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Intervention Type
Other
Intervention Name(s)
Late spa treatment
Other Intervention Name(s)
Spa treatment after 6 months visit in the study
Intervention Description
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Primary Outcome Measure Information:
Title
Handicap in everyday life
Description
Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Pain evolution
Description
Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Sleep quality
Description
Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Fatigue
Description
Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Depression
Description
Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Ability to cope
Description
Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months
Time Frame
at baseline, 6 and 12 months
Title
Physical activity
Description
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
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Medico economic impact
Description
Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.
Time Frame
at baseline, 3, 6, 9 and 12 months
Title
Objective physical activity
Description
Record of day activity during one week with actigraphy at baseline, 3 and 6 months
Time Frame
at baseline, 3, and 6 months
Title
Objective sleep quality
Description
Record of night activity and cardiac variability at baseline, 3 and 6 months
Time Frame
at baseline, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline MAINDET DOMINICI, MD
Organizational Affiliation
Hospital University Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
station thermale AIX LES BAINS
City
Aix les Bains
ZIP/Postal Code
73100
Country
France
Facility Name
station thermale ALLEVARD LES BAINS
City
Allevard
ZIP/Postal Code
38580
Country
France
Facility Name
station thermale BOURBON LANCY
City
Bourbon-Lancy
ZIP/Postal Code
71140
Country
France
Facility Name
station thermale LAMALOU LES BAINS
City
Lamalou les Bains
ZIP/Postal Code
34240
Country
France
Facility Name
Station thermale URIAGE LES BAINS
City
Uriage les bains
ZIP/Postal Code
38410
Country
France

12. IPD Sharing Statement

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Evaluation of Spa Therapy in the Treatment of Fibromyalgia

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