Thermal Cures in the Treatment of Multiple Sclerosis

NCT ID: NCT03915028

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated group by thermal cure

Treated group will benefit, within 6 weeks of the inclusion, from the thermal cure in one of the thermal establishments.

Group Type EXPERIMENTAL

Spa therapy

Intervention Type OTHER

The standardized treatment will consist of 4 spa treatments per day for 3 consecutive weeks.

Each day, the patient receives at least four treatments, among which:

* Cure of Drink (in addition to 4 daily cares)
* Bath in running water: Bath
* Bath in running water: Pool at 32 ° C
* Bath with aerobain
* Immersion shower bath
* Shower of high pressure under immersion in swimming pool
* General penetrating shower
* General jet shower
* Local jet shower
* Local mud bath at the feet
* Single poultice
* Multiple poultice
* Compress
* Mobilization pool
* Massages under water

Control group

Control group will receive a thermal cure after the end of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spa therapy

The standardized treatment will consist of 4 spa treatments per day for 3 consecutive weeks.

Each day, the patient receives at least four treatments, among which:

* Cure of Drink (in addition to 4 daily cares)
* Bath in running water: Bath
* Bath in running water: Pool at 32 ° C
* Bath with aerobain
* Immersion shower bath
* Shower of high pressure under immersion in swimming pool
* General penetrating shower
* General jet shower
* Local jet shower
* Local mud bath at the feet
* Single poultice
* Multiple poultice
* Compress
* Mobilization pool
* Massages under water

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle LAFFONT

Role: CONTACT

04 67 33 23 46

Facility Contacts

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Isabelle LAFFONT, PU-PH

Role: primary

0467338664

Other Identifiers

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2018-A02411-54

Identifier Type: -

Identifier Source: org_study_id

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