Thermal Cures in the Treatment of Multiple Sclerosis (SPA-SEP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03915028 |
Recruitment Status : Unknown
Verified March 2019 by Association Francaise pour la Recherche Thermale.
Recruitment status was: Recruiting
First Posted : April 16, 2019
Last Update Posted : July 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Other: Spa therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life |
Actual Study Start Date : | May 23, 2019 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Other: Spa therapy
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:
|
No Intervention: Control group
Control group will receive a thermal cure after the end of the study
|
- Benefit of spa treatment on quality of life assessed by the scale SEP-59 [ Time Frame: 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).
- Benefit of a spa treatment based on average number of steps per day for one week assessed by actimeter [ Time Frame: 9 weeks after inclusion ]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 [ Time Frame: 15 to 17 weeks after inclusion ]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 [ Time Frame: 15 to 17 weeks after inclusion ]
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 [ Time Frame: 15 to 17 weeks after inclusion ]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 [ Time Frame: 15 to 17 weeks after inclusion ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915028
Contact: Isabelle LAFFONT | 04 67 33 23 46 | i-laffont@chu-montpellier.fr |
France | |
Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE | Recruiting |
Montpellier, France, 34295 | |
Contact: Isabelle LAFFONT, PU-PH 0467338664 i-laffont@chu-montpellier.fr |
Responsible Party: | Association Francaise pour la Recherche Thermale |
ClinicalTrials.gov Identifier: | NCT03915028 |
Other Study ID Numbers: |
2018-A02411-54 |
First Posted: | April 16, 2019 Key Record Dates |
Last Update Posted: | July 10, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple sclerosis Spa treatment Crenotherapy Balneotherapy Physical exercise |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |