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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | Control group will receive a thermal cure after the end of the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle LAFFONT | Contact | 04 67 33 23 46 | i-laffont@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |