Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2019-06-20
2025-12-31
Brief Summary
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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.
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Detailed Description
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The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema.
The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Immediate spa therapy: the patient carries out the spa therapy with education therapeutic soon after the enrolment in the study
* Late spa therapy: the patient carries out the spa therapy with education therapeutic after the 6-month follow up
OTHER
SINGLE
Study Groups
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Immediate spa treatment
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
Immediate spa treatment
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)
Late spa treatment
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
Late spa treatment
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)
Interventions
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Immediate spa treatment
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)
Late spa treatment
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Floralis
INDUSTRY
Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Principal Investigators
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Patrick CARPENTIER, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital University Grenoble
Locations
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Cabinet de médecine vasculaire
Albertville, , France
CHU Amiens Picardie
Amiens, , France
Thermes Argelès-Gazost
Argelès-Gazost, , France
Thermes Barbotan Les Bains
Barbotan-les-Thermes, , France
Groupe Hospitalier Mutualiste
Grenoble, , France
Thermes La Léchère
La Léchère, , France
CH Lourdes
Lourdes, , France
Thermes Luz Saint Sauveur
Luz-Saint-Sauveur, , France
Centre Léon Berard
Lyon, , France
CH Tarbes
Tarbes, , France
CHU Toulouse
Toulouse, , France
Clinique générale HPDA
Valence, , France
Clinique du Tonkin
Villeurbanne, , France
Countries
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Central Contacts
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References
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Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.
International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003 Jun;36(2):84-91.
Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.
Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5.
Norman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res. 2004 Oct;4(5):581-5. doi: 10.1586/14737167.4.5.581.
Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
Devoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7.
Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.
Vignes S. [Management of limb lymphedema]. Rev Med Interne. 2012 May;33(5):268-72. doi: 10.1016/j.revmed.2011.12.012. Epub 2012 Jan 31. French.
Carpentier PH, Fabry R. Crénothérapie des maladies vasculaires. In: Queneau P, editor. Médecine Thermale, faits et preuves. Paris: Masson Ed; 2000. p. 102-15.
Carpentier PH, Colomb M, Poensin D, Satger B. [Incidence of erysipelas of the lower limbs in a spa resort. Efficacy of a strategy of sanitation education (La Lechere: 1992-1997)]. J Mal Vasc. 2001 Apr;26(2):97-9. French.
Blaise S, Villemur B, Richaud C, Rastel D, Bucci B, Evra V, Bouchet JY, les membres du réseau GRANTED, B.Satger. Conception d'un programme d'éducation thérapeutique pour les patients porteurs de lymphoedème : " Vivre avec un lymphoedème ". J Mal Vasc 2011,online access : doi:10.1016/j.jmv.2011.10.006
Carpentier PH, Satger B, Poensin D, Trens C, Arnold M, Trolliet C, Noilhetas J, Chauvin E, Laurès J Therapeutic education combined with balneotherapy in lymphedema patients. Communication acceptée à l'American Venous Forum (Orlando 25/02/2016, publication en préparation)
Launois R, Alliot F. Quality of Life Scale in Upper Limb Lymphoedema - A validation Study. Lymphology 33, 2000 (Suppl) : 266-74.
Lim P, Li H, Neoh D, Ng SK. Health-related Quality of Life Measurement Tools for Lymphedema: A Review of the Literature. Plast Reconstr Surg Glob Open. 2022 Apr 27;10(4):e4276. doi: 10.1097/GOX.0000000000004276. eCollection 2022 Apr.
Keeley, Vaughan; Crooks, Sue; Locke, Jane; Veigas, Debbie; Riches, Katie and Hilliam, Rachel (2010). A quality of life measure for limb lymphoedema (LYMQOL). Journal of Lymphoedema, 5(1) pp. 26-37
Other Identifiers
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THERMOEDEME
Identifier Type: -
Identifier Source: org_study_id
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