Spa Therapy for Upper or Lower Limb Lymphoedema
Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
Association Francaise pour la Recherche Thermale
160 participants
Jun 20, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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
- pregnancy, parturient or breast feeding
Interventions
Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)
Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT03580109