Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)
NCT ID: NCT05449743
Last Updated: 2024-12-19
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-07-11
2024-11-25
Brief Summary
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Detailed Description
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* prospective, before/after, cohort follow-up study with repeated measurements
* monocentric study with the dispensation of a 3-week phlebology-oriented spa therapy in Neyrac-les-Bains
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patient treated with a phlebology-oriented spa therapy
Thermal treatments among the following: pool, Kneipp pool, high pressure shower under immersion in a swimming pool, general jet shower, cataplasm in multiple local application, compress, massage under water or with thermal derivatives, walking corridor
Spa therapy
Thermal treatments among the following: pool, Kneipp pool, high pressure shower under immersion in a swimming pool, general jet shower, cataplasm in multiple local application, compress, massage under water or with thermal derivatives, walking corridor
Interventions
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Spa therapy
Thermal treatments among the following: pool, Kneipp pool, high pressure shower under immersion in a swimming pool, general jet shower, cataplasm in multiple local application, compress, massage under water or with thermal derivatives, walking corridor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with chronic venous insufficiency of the lower limbs (CEAP category C4a, C4b and C4c)
* Patient presenting an indication for a phlebology-oriented spa treatment as the primary orientation. Patients with a dermatological or rheumatological pathology can benefit from a dual orientation spa treatment with a main phlebology orientation
* Patient affiliated to the social security system or such a system
* Available for an 18-day spa treatment and a 6-month follow-up
* For women of childbearing age: effective contraception
* Patient close to a study investigator (excluding teleconsultation) If not patient with access to the necessary equipment to perform a teleconsultation (smartphone, tablet or computer with an internet connection + taking and sending photos of the lower limbs)
* Venous surgery or venous interventional therapy within 3 months prior to inclusion or scheduled within the next 3 months
* History of venous ulcer
* Contraindication to spa therapy (immune deficiency, evolving cardiopathy neoplasia, infection, pulmonary tuberculosis, severe renal insufficiency, alcoholic cirrhosis, advanced senility and severe mental disorders)
* Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.)
* Persons suffering from venous insufficiency of the varicose vein type (category CEAP C2) or edema alone (category CEAP C3) or open or healed ulcers (CEAP category C5 and C6)
* Patient who has already undergone a phlebology-oriented spa treatment within the current thermal season
* Subject already included in an interventional clinical research protocol
* Persons referred to in articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
18 Years
ALL
No
Sponsors
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Floralis
INDUSTRY
University Grenoble Alps
OTHER
thermes de NEYRAC
UNKNOWN
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
OTHER
Responsible Party
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Locations
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CHU Grenoble Alpes
Grenoble, , France
Laboratoire TIMC
Grenoble, , France
Countries
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References
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Kim Y, Png CYM, Sumpio BJ, DeCarlo CS, Dua A. Defining the human and health care costs of chronic venous insufficiency. Semin Vasc Surg. 2021 Mar;34(1):59-64. doi: 10.1053/j.semvascsurg.2021.02.007. Epub 2021 Feb 3.
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.
Launois R. Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs. J Vasc Surg Venous Lymphat Disord. 2015 Apr;3(2):219-27.e1-3. doi: 10.1016/j.jvsv.2014.08.005. Epub 2014 Oct 29.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
Related Links
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\[Anaes 1999\] Evaluation et suivi de la douleur chronique chez l'adulte en médecine ambulatoire. Agence nationale d'accréditation et d'évaluation en santé. Recommandations et références professionnelles. Février 1999
\[Queneau 2016\] Press Therm Climat 2016;153:9-24
Other Identifiers
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2021-A00545-36
Identifier Type: -
Identifier Source: org_study_id