Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)

NCT05449743 | Completed

• 1 other identifier: 2021-A00545-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation of the effectiveness of a phlebology-oriented spa therapy at 6 months on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs

Conditions

Chronic Venous Insufficiency

Keywords

spa therapy; phlebology; chronic venous insufficiency

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of a complete phlebology-oriented spa therapy on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs

  Comparison of the mean scores of the Chronic Venous Insufficiency specific Quality of life questionnaire (CIVIQ20) at baseline and at 6 months. The 20-item questionnaire, which provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale were scored from 1 to 5 which means a total score from 20 to 100. A higher score means a worse outcome.

  6 months

Secondary Outcomes (15)

• Comparison of Visual Analog Scales (VAS) for pain at enrolment and 1.5, 3, 4.5 and 6 months after enrolment (post-cure) to quantitatively assess the improvement of patients' pain before/after treatment

  1.5, 3, 4.5 and 6 months

• Assessment of the global quality of life by the EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L).

  3 and 6 months

• Physician/Patient perception

  3 and 6 months

• Medication consumption

  6 months

• Assessment of compression compliance

  3 and 6 months

Study Arms (1)

patient treated with a phlebology-oriented spa therapy

EXPERIMENTAL

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: Spa therapy

Interventions

Spa therapy OTHER

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

Also known as: spa treatment, spa care

patient treated with a phlebology-oriented spa therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• 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)
• 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)

Sponsors & Collaborators

• Le Syndicat Intercommunal pour le Thermalisme et l'Environnement: lead
• Floralis: collaborator
• University Grenoble Alps: collaborator
• thermes de NEYRAC: collaborator

Study Sites (2)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Laboratoire TIMC

Grenoble, 38043, France

Location

Related Publications (5)

• 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.

  PMID: 33757637 BACKGROUND

• 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.

  PMID: 24135621 BACKGROUND

• 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.

  PMID: 26993844 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• 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.

  PMID: 3068365 BACKGROUND

Related Links

• \[Anaes 1999\] 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before / after study

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 8, 2022
• Study Start: July 11, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

FR (2)