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

Status unknownNot a drug-phase studyMS (type not specified)NCT03915028

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Spa therapy

What it measured

Main measures

  • Benefit of spa treatment on quality of life assessed by the scale SEP-59

    within 15 weeks after inclusion

    Physical functionPainQuality of life (reported by participants)

Other measures (5)

  • Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter

    9 weeks after inclusion

    Physical function
  • Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care

    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

    15 to 17 weeks after inclusion

    PainMood and sleep
  • Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale

    15 to 17 weeks after inclusion

    FatiguePain
  • Benefit of a thermal cure regarding pain assessed by the scale DN 4

    15 to 17 weeks after inclusion

    Pain

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      May 2019

    2. Main results due

      May 2021

    3. Finished

      Aug 2021

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