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

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.

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.

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.

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.

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

Comparison of the self-reported compression compliance (percentage of wearing time in the last week), between baseline and 3 and 6 months after enrolment

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.

Comparison of the Body Mass Index between enrolment, and 3 months and 6 months after enrolment

Comparison of the systolic blood pressure between enrolment, and 3 months and 6 months after enrolment

Comparison of the diastolic blood pressure between enrolment, and 3 months and 6 months after enrolment

Comparison of the heart rate between enrolment, and 3 months and 6 months after enrolment

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.

Collection of medical events related or not to venous insufficiency (number of SAE, number of hospitalizations, number of medical and paramedical procedures)

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

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.

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.