Back to resultsThermal Cures in the Treatment of Multiple Sclerosis (SPA-SEP)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spa therapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Spa treatment, Crenotherapy, Balneotherapy, Physical exercise
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
Sites / Locations
- Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIERecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treated group by thermal cure
Control group
Arm Description
Treated group will benefit, within 6 weeks of the inclusion, from the thermal cure in one of the thermal establishments.
Control group will receive a thermal cure after the end of the study
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
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).
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.
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
Full Information
NCT ID
NCT03915028
First Posted
March 12, 2019
Last Updated
July 9, 2019
Sponsor
Association Francaise pour la Recherche Thermale
1. Study Identification
Unique Protocol Identification Number
NCT03915028
Brief Title
Thermal Cures in the Treatment of Multiple Sclerosis
Acronym
SPA-SEP
Official Title
Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Spa treatment, Crenotherapy, Balneotherapy, Physical exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treated group by thermal cure
Arm Type
Experimental
Arm Description
Treated group will benefit, within 6 weeks of the inclusion, from the thermal cure in one of the thermal establishments.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive a thermal cure after the end of the study
Intervention Type
Other
Intervention Name(s)
Spa therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Benefit of spa treatment on quality of life assessed by the scale SEP-59
Description
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).
Time Frame
within 15 weeks after inclusion
Secondary Outcome Measure Information:
Title
Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter
Description
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.
Time Frame
9 weeks after inclusion
Title
Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care
Description
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
Time Frame
15 to 17 weeks after inclusion
Title
Benefit of a thermal cure based on depression and anxiety assessed by the scale Hospital Anxiety and depression scale
Description
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).
Time Frame
15 to 17 weeks after inclusion
Title
Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale
Description
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.
Time Frame
15 to 17 weeks after inclusion
Title
Benefit of a thermal cure regarding pain assessed by the scale DN 4
Description
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
Time Frame
15 to 17 weeks after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle LAFFONT
Phone
04 67 33 23 46
Email
i-laffont@chu-montpellier.fr
Facility Information:
Facility Name
Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle LAFFONT, PU-PH
Phone
0467338664
Email
i-laffont@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Thermal Cures in the Treatment of Multiple Sclerosis
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