Thermal Cures in the Treatment of Multiple Sclerosis (SPA-SEP)

A

Association Francaise pour la Recherche Thermale

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Other: Spa therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03915028
2018-A02411-54

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Treated group by thermal cure
Experimental group
Description:
Treated group will benefit, within 6 weeks of the inclusion, from the thermal cure in one of the thermal establishments.
Treatment:
Other: Spa therapy
Control group
No Intervention group
Description:
Control group will receive a thermal cure after the end of the study

Trial contacts and locations

0

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Central trial contact

Isabelle LAFFONT

Data sourced from clinicaltrials.gov

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