Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Benefit of spa treatment on quality of life assessed by the scale SEP-59
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Spa therapy (Other)
Control group
Control group will receive a thermal cure after the end of the study
结局指标
主要结局
Benefit of spa treatment on quality of life assessed by the scale SEP-59
时间窗: within 15 weeks after inclusion
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).
次要结局
- Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care(15 to 17 weeks after inclusion)
- 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 depression and anxiety assessed by the scale Hospital Anxiety and depression 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)
- Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale(15 to 17 weeks after inclusion)