Clinical trial NCT03915028: Thermal Cures in the Treatment of Multiple Sclerosis
Official title: Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Spa treatment
Crenotherapy
Balneotherapy
Physical exercise
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple Sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, with significant public health consequences. The benefit of spa treatments on the quality of life in this population has not been evaluated. The methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

Detailed description: Multiple sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, and its consequences in terms of public health are important. In this disease, the alteration of the quality of life (QoL) is constant and multifactorial : pain, fatigue, decrease in functional capacities, sleep disorders, cognitive disorders, vesico-sphincterian disorders, anomolytic disorders. -rectal and genito-sexual. The benefit of thermal cures on the quality of life in this population has not been evaluated, even if there is some literature in the literature suggesting a benefit of hydrotherapy on equilibrium or on pain.

Eligibility criteria: Inclusion Criteria:

* Patient with primary or progressive secondary-phase MS
* Showing EDSS \<7 severity criteria
* Patient with MS for whom an indication of spa treatment has been made,
* Patient agreeing to participate in this study and therefore accepting the constraints related to the design "immediate cure-deferred cure",
* Patient receiving the general social security scheme,
* Patient having given written consent to participate in the study

Exclusion Criteria:

* Patient does not meet the inclusion criteria,
* Patient with relapsing remitting MS
* Patient unfit according to the investigator to complete the rating scales
* Patient with heat intolerance called "Uhthoff effect"
* Patient with a contraindication to the spa treatment: urinary or faecal leakage, wound, thrombophlebitis less than three months old, unstabilized cardio respiratory disease.
* Patient with serious life-threatening condition (ie, cancer)
* Patient under tutorship or curatorship
* Patient participating in another interventional clinical research project

Primary outcomes:
measure: Benefit of spa treatment on quality of life assessed by the scale SEP-59
timeFrame: within 15 weeks after inclusion
Secondary outcomes:
measure: Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter
timeFrame: 9 weeks after inclusion
measure: Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care
timeFrame: 15 to 17 weeks after inclusion
measure: Benefit of a thermal cure based on depression and anxiety assessed by the scale Hospital Anxiety and depression scale
timeFrame: 15 to 17 weeks after inclusion
measure: Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale
timeFrame: 15 to 17 weeks after inclusion
measure: Benefit of a thermal cure regarding pain assessed by the scale DN 4
timeFrame: 15 to 17 weeks after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE
Study officials:
References: