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

Evaluation of the Effectiveness of a Phlebology-oriented Spa Treatment on the Quality of Life of Patients Suffering From Chronic Venous Insufficiency of the Lower Limbs, 6-month After the Spa Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Other: Spa therapy

Detailed Description

NEYRAC is a:

• 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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexa COMTE; Phone Number: 04 76 76 66 39; Email: alexa.comte@univ-grenoble-alpes.fr
• Study Contact Backup: Name: Carole ROLLAND; Phone Number: 04 76 76 50 40; Email: carole.rolland@univ-grenoble-alpes.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Sophie BLAISE, MD,PhD; Phone Number: +33(0)476 76 55 47; Email: SBlaise@chu-grenoble.fr
  • Grenoble, France, 38043
    • Recruiting
    • Laboratoire TIMC
    • Contact: Jean-Luc BOSSON, MD, PhD; Phone Number: 04 76 76 50 40; Email: Jean-Luc.Bosson@univ-grenoble-alpes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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)

Non inclusion criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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 Names: spa treatment; spa care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of the means of Visual Analog Scales (VAS) at enrolment an 1.5, 3, 4.5 and 6 months after enrolment. Score from 0 to 100. A higher score means a worse outcome.	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).	Improvement in global quality of life (EQ5D-5L questionnaire) between enrolment and at 3 and 6 months after enrolment The EQ5D-5L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). There are five dimensions assessed in the descriptive system: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Score from -0.53 to 1. A higher score means better outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Score from 0 to 100. A higher score means better outcome.	3 and 6 months
Physician/Patient perception	The perception of the physician and the patient will be asked to evaluate the benefit of the spa therapy, 3 and 6 months after enrolment using a 5-point Likert scale. There are no numerical scores, only results in % of patients improved or worsened.	3 and 6 months
Medication consumption	Collection of medication consumption to evaluate the benefit of the spa therapy (comparison of consumption before and after treatment) To avoid any risk of confusion, medication consumption will be set to the daily consumption. Medication use for 72 hours (D-2, D-1, D0) Medication consumption day before yesterday/yesterday/today: Anticoagulant; Veinotonic In the 3 months prior to the visit: Medication use will be assessed by the investigating physician who will have to specify if this one is consumed because of the venous insufficiency or of another pathology	6 months
Assessment of compression compliance	Comparison of the self-reported compression compliance (percentage of wearing time in the last week), between baseline and 3 and 6 months after enrolment	3 and 6 months
Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category	Comparison of CEAP category assessed by the investigating physician between enrolment and 3 and 6 months after enrolment The basic principles of the CEAP classification include a description of the clinical class (C) based on objective signs, the etiology (E), the anatomical distribution (A) of reflux and obstructions in superficial, deep and perforating veins and the underlying pathophysiology (P), whether related to reflux or obstructions. Only the clinical class (C) and the etiology (E) will be assessed.	3 and 6 months
Evolution of the general clinical criteria : Body Mass Index (BMI)	Comparison of the Body Mass Index between enrolment, and 3 months and 6 months after enrolment	3 and 6 months
Evolution of the general clinical criteria : systolic blood pressure	Comparison of the systolic blood pressure between enrolment, and 3 months and 6 months after enrolment	3 and 6 months
Evolution of the general clinical criteria : diastolic blood pressure	Comparison of the diastolic blood pressure between enrolment, and 3 months and 6 months after enrolment	3 and 6 months
Evolution of the general clinical criteria : heart rate	Comparison of the heart rate between enrolment, and 3 months and 6 months after enrolment	3 and 6 months
Evaluation of the Rutherford score at enrolment and at 3 months and at 6 months after enrolment to estimate the clinical severity of venous insufficiency	Comparison of mean scores between enrolment and 3 months and 6 months after enrolment. The Rutherford questionnaire is the Venous Clinical Severity Score (VCSS) questionnaire without the compression part. The Rutherford questionnaire includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. In order to generate a dynamic score, the categories are scored individually, which adds emphasis to the most severe sequelae of venous disease that are likely to show the greatest response to therapy. These include skin changes and pigmentation, inflammation and induration, and ulcers (including number, size, and duration). Score from 0 to 27. A higher score means a worse outcome.	3 and 6 months
Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment	Collection of medical events related or not to venous insufficiency (number of SAE, number of hospitalizations, number of medical and paramedical procedures)	6 months
Evaluation of compliance with the spa therapy	Comparison of the thermal treatments received by the patient during the spa therapy with the thermal treatments prescribed by the thermal doctor at the start of the spa therapy, collected in the spa treatment booklet	3 weeks
Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire	Quantitative improvement of the health status of all patients by comparison of the mean of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 3 months and 6 months for all patients, and then only for patients with osteoarthritis The WOMAC is the validated index for the assessment of lower limb osteoarthritis according to a Likert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4) Scores from 0 to 100. A higher score means a worse outcome.	3 and 6 months
Comparison of the effictiveness of the treatment according to the limitation of the patient's walking (subgroup analysis according to patient mobility)	Comparison of the primary endpoint Chronic Venous Insufficiency specific Quality of life questionnaire (CIVIQ20) according to the limitation of the patient's walking (limitation of the walking is self reported by the patient) 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

Collaborators and Investigators

• Sponsor: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
• Collaborators: University Grenoble Alps; Floralis

Publications and helpful links

General Publications

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

Helpful 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 record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: chronic venous insufficiency; spa therapy; phlebology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 2021-A00545-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No