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Recruiting NCT03580109

Spa Therapy for Upper or Lower Limb Lymphoedema

Trial Parameters

Condition Lymphoedema
Sponsor Association Francaise pour la Recherche Thermale
Study Type INTERVENTIONAL
Phase N/A
Enrollment 160
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2019-06-20
Completion 2024-12
Interventions
Immediate spa treatmentLate spa treatment

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * cancer undergoing chemotherapy and radiotherapy treatment in primary phase * the baseline score of LMS27 or LYMQOL-LEG \> 79 * pain of upper limb linked with a radical plexitis * contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency) * Erysipelas case history in the last 6 months or pachyderma and lymphangiectasia * no previous spa treatment for upper limb lymphoedema during the spa year * risk of intensive treatment in the next 6 months * subject participating to an other clinical study interventional

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