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

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency

• Registration Number: NCT05449743
• Lead Sponsor: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement

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

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 Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Study Start: 2022-07-11
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	6 months	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Medication consumption	6 months	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
Assessment of compression compliance	3 and 6 months	Comparison of the self-reported compression compliance (percentage of wearing time in the last week), between baseline and 3 and 6 months after enrolment
Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category	3 and 6 months	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.
Assessment of the global quality of life by the EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L).	3 and 6 months	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.
Physician/Patient perception	3 and 6 months	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.
Evolution of the general clinical criteria : systolic blood pressure	3 and 6 months	Comparison of the systolic blood pressure between enrolment, and 3 months and 6 months after enrolment
Evolution of the general clinical criteria : diastolic blood pressure	3 and 6 months	Comparison of the diastolic blood pressure between enrolment, and 3 months and 6 months after enrolment
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	3 and 6 months	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.
Comparison of the effictiveness of the treatment according to the limitation of the patient's walking (subgroup analysis according to patient mobility)	6 months	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.
Evolution of the general clinical criteria : Body Mass Index (BMI)	3 and 6 months	Comparison of the Body Mass Index between enrolment, and 3 months and 6 months after enrolment
Evaluation of compliance with the spa therapy	3 weeks	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
Evolution of the general clinical criteria : heart rate	3 and 6 months	Comparison of the heart rate between enrolment, and 3 months and 6 months after enrolment
Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment	6 months	Collection of medical events related or not to venous insufficiency (number of SAE, number of hospitalizations, number of medical and paramedical procedures)
Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire	3 and 6 months	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.

Trial Locations

Locations (2)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

Laboratoire TIMC; 🇫🇷 Grenoble, France