Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years old and older
• available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months
• with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of International Society for Lymphology scale)
• voluntary to participate to the study, informed consent form signed after appropriate information
• affiliation to the social security system or equivalent
Locations
Other Locations
France
Cabinet de médecine vasculaire
RECRUITING
Albertville
CHU Amiens Picardie
RECRUITING
Amiens
Thermes Argelès-Gazost
RECRUITING
Argelès-gazost
Thermes Barbotan Les Bains
RECRUITING
Barbotan-les-thermes
Groupe Hospitalier Mutualiste
RECRUITING
Grenoble
Thermes La Léchère
RECRUITING
La Léchère
CH Lourdes
RECRUITING
Lourdes
Thermes Luz Saint Sauveur
RECRUITING
Luz-saint-sauveur
Centre Léon Berard
RECRUITING
Lyon
CH Tarbes
RECRUITING
Tarbes
CHU Toulouse
RECRUITING
Toulouse
Clinique générale HPDA
RECRUITING
Valence
Clinique du Tonkin
RECRUITING
Villeurbanne
Contact Information
Primary
Alexa COMTE
alexa.comte@univ-grenoble-alpes.fr
334 76 76 66 39
Backup
Carole ROLLAND
carole.rolland@univ-grenoble-alpes.fr
334 76 76 69 03
Time Frame
Start Date: 2019-06-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 160
Treatments
Active_comparator: Immediate spa treatment
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
Sham_comparator: Late spa treatment
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
Authors
Michèle Fontaine
Related Therapeutic Areas
Sponsors
Leads: Association Francaise pour la Recherche Thermale
Collaborators: Floralis