An interventional study of Spa therapy in Multiple Sclerosis, sponsored by Association Francaise pour la Recherche Thermale. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Association Francaise pour la Recherche Thermale · Not applicable, Interventional, and Treatment
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.
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.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Association Francaise pour la Recherche Thermale is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 will receive a thermal cure after the end of the study
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
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).
Time frame: within 15 weeks after inclusion
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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 15 to 17 weeks after inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2019 (actual). Primary completion is estimated for May 2021, 24 months after the start.
Of 868 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is close to that.
Counting every sponsor, half of 889 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Association Francaise pour la Recherche Thermale