Multiple SclerosisSPA-SEPNCT03915028
Thermal Cures in the Treatment of Multiple Sclerosis
A study testing Spa therapy in people with Multiple Sclerosis, run by Association Francaise pour la Recherche Thermale at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2019to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE
Montpellier, 34295
Isabelle LAFFONT, PU-PH, 0467338664, i-laffont@chu-montpellier.fr
About this study
Official title: Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Spa therapy
- Keywords
- Multiple sclerosis, Spa treatment, Crenotherapy, Balneotherapy, Physical exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Spa therapy |
| Control group | No intervention | Control group will receive a thermal cure after the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 15 weeks after inclusion
Secondary outcomes (5)
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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 15 to 17 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start23 May 2019
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915028
- Sponsor's protocol ID
- 2018-A02411-54
- Acronym
- SPA-SEP
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life
- ClinicalTrials.gov ID
- NCT03915028
- Acronym / sponsor ID
- SPA-SEP / 2018-A02411-54
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Spa treatment, Crenotherapy, Balneotherapy, Physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group by thermal cure | Experimental | Other: Spa therapyTreated group will benefit, within 6 weeks of the inclusion, from the thermal cure in one of the thermal establishments. |
| Control group | No intervention | –Control group will receive a thermal cure after the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapyThe 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 | Other | Treated group by thermal cure |
Primary outcome
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).
5 secondary outcomes
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
Benefit of a thermal cure based on treatment consumption of hospital and ambulatory care
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
Time frame: 15 to 17 weeks after inclusion
Benefit of a thermal cure based on tiredness assesed by the fatigue impact scale
Time frame: 15 to 17 weeks after inclusion
Benefit of a thermal cure regarding pain assessed by the scale DN 4
Time frame: 15 to 17 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy in people with Multiple Sclerosis, run by Association Francaise pour la Recherche Thermale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle LAFFONT (04 67 33 23 46, i-laffont@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benefit of spa treatment on quality of life assessed by the scale SEP-59 (time frame: within 15 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.