Thermal Cures in the Treatment of Multiple Sclerosis

NCT03915028 | Unknown

• 1 other identifier: 2018-A02411-54
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Spa treatment; Crenotherapy; Balneotherapy; Physical exercise

Outcome Measures

Primary Outcomes (1)

• Benefit of spa treatment on quality of life assessed by the scale SEP-59

  Difference of the score of quality of live assessed by the scale SEP-59 between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately. SEP-59 is built on the basis of a generic scale, the SF-36. The analysis of SEP-59 is done by computer processing in order to calculate the score of the various axes (pain, physical activity, general wellbeing ...) which are independent (there is no overall score).

  within 15 weeks after inclusion

Secondary Outcomes (5)

• Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter

  9 weeks after inclusion

• Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care

  15 to 17 weeks after inclusion

• Benefit of a thermal cure based on depression and anxiety assessed by the scale Hospital Anxiety and depression scale

  15 to 17 weeks after inclusion

• Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale

  15 to 17 weeks after inclusion

• Benefit of a thermal cure regarding pain assessed by the scale DN 4

  15 to 17 weeks after inclusion

Study Arms (2)

Treated group by thermal cure

EXPERIMENTAL

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

Other: Spa therapy

Control group

NO INTERVENTION

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

Interventions

Spa therapy 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

Treated group by thermal cure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead

Study Sites (1)

Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Central Study Contacts

Isabelle LAFFONT

CONTACT

04 67 33 23 46; i-laffont@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 16, 2019
• Study Start: May 23, 2019
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-03

Locations

FR (1)