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

Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Spa therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE
    • Contact: Isabelle LAFFONT, PU-PH; Phone Number: 0467338664; Email: i-laffont@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
No Intervention: Control group; Control group will receive a thermal cure after the end of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter	Difference of the average number of steps per day for one week between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately.	9 weeks after inclusion
Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care	Difference of the number of treatment consumption of hospital and ambulatory care between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately	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	Difference of the level of pain assessed by the scale Hospital Anxiety and depression between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately.HADS is a self-administered scale of 14 items, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). It contains no somatic item that can be confused with symptomatic manifestations of a disease. Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales and for the entire HADS (HADS-T). Limit scores distinguish between: non-cases or asymptomatic cases (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).	15 to 17 weeks after inclusion
Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale	Difference of the level of pain assessed by the fatigue impact scale between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately. It is a self-assessment tool in which the patient is asked to note the extent to which fatigue has caused them problems in certain situations. (0 = no problem, 4 = extreme problems). A maximum score of 160 is obtained for the 40 items.	15 to 17 weeks after inclusion
Benefit of a thermal cure regarding pain assessed by the scale DN 4	Difference of the level of pain assessed by the DN4 scale between the patient will receive the immediat spa therapy and the second group which won't receive the spa therapy immediately	15 to 17 weeks after inclusion

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Physical exercise; Balneotherapy; Crenotherapy; Spa treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2018-A02411-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No