Back to resultsAssessment of the Effect of Spa Therapy on the Quality of Life of Patients With Chronic Venous Insufficiency (NEYRAC) (NEYRAC)
Primary Purpose
Chronic Venous Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spa therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring spa therapy, phlebology, chronic venous insufficiency
Eligibility Criteria
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)
Sites / Locations
- CHU Grenoble AlpesRecruiting
- Laboratoire TIMCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient treated with a phlebology-oriented spa therapy
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
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.
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
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
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
Evolution of the general clinical criteria : heart rate
Comparison of the heart rate 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
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.
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)
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
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.
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.
Full Information
NCT ID
NCT05449743
First Posted
June 23, 2022
Last Updated
December 29, 2022
Sponsor
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
Collaborators
Floralis, University Grenoble Alps
1. Study Identification
Unique Protocol Identification Number
NCT05449743
Brief Title
Assessment of the Effect of Spa Therapy on the Quality of Life of Patients With Chronic Venous Insufficiency (NEYRAC)
Acronym
NEYRAC
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
Collaborators
Floralis, University Grenoble Alps
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
spa therapy, phlebology, chronic venous insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
before / after study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient treated with a phlebology-oriented spa therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Spa therapy
Other Intervention Name(s)
spa treatment, spa care
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1.5, 3, 4.5 and 6 months
Title
Assessment of the global quality of life by the EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L).
Description
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.
Time Frame
3 and 6 months
Title
Physician/Patient perception
Description
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.
Time Frame
3 and 6 months
Title
Medication consumption
Description
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
Time Frame
6 months
Title
Assessment of compression compliance
Description
Comparison of the self-reported compression compliance (percentage of wearing time in the last week), between baseline and 3 and 6 months after enrolment
Time Frame
3 and 6 months
Title
Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category
Description
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.
Time Frame
3 and 6 months
Title
Evolution of the general clinical criteria : Body Mass Index (BMI)
Description
Comparison of the Body Mass Index between enrolment, and 3 months and 6 months after enrolment
Time Frame
3 and 6 months
Title
Evolution of the general clinical criteria : systolic blood pressure
Description
Comparison of the systolic blood pressure between enrolment, and 3 months and 6 months after enrolment
Time Frame
3 and 6 months
Title
Evolution of the general clinical criteria : diastolic blood pressure
Description
Comparison of the diastolic blood pressure between enrolment, and 3 months and 6 months after enrolment
Time Frame
3 and 6 months
Title
Evolution of the general clinical criteria : heart rate
Description
Comparison of the heart rate between enrolment, and 3 months and 6 months after enrolment
Time Frame
3 and 6 months
Title
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
Description
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.
Time Frame
3 and 6 months
Title
Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment
Description
Collection of medical events related or not to venous insufficiency (number of SAE, number of hospitalizations, number of medical and paramedical procedures)
Time Frame
6 months
Title
Evaluation of compliance with the spa therapy
Description
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
Time Frame
3 weeks
Title
Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Description
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.
Time Frame
3 and 6 months
Title
Comparison of the effictiveness of the treatment according to the limitation of the patient's walking (subgroup analysis according to patient mobility)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa COMTE
Phone
04 76 76 66 39
Email
alexa.comte@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carole ROLLAND
Phone
04 76 76 50 40
Email
carole.rolland@univ-grenoble-alpes.fr
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie BLAISE, MD,PhD
Phone
+33(0)476 76 55 47
Email
SBlaise@chu-grenoble.fr
Facility Name
Laboratoire TIMC
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc BOSSON, MD, PhD
Phone
04 76 76 50 40
Email
Jean-Luc.Bosson@univ-grenoble-alpes.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
33757637
Citation
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.
Results Reference
background
PubMed Identifier
24135621
Citation
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.
Results Reference
background
PubMed Identifier
26993844
Citation
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.
Results Reference
background
PubMed Identifier
4139420
Citation
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Results Reference
background
PubMed Identifier
3068365
Citation
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.
Results Reference
background
Links:
URL
https://www.has-sante.fr/upload/docs/application/pdf/douleur1.pdf
Description
[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
URL
https://www.academie-medecine.fr/wp-content/uploads/2016/10/Article-de-la-Presse-thermale.pdf
Description
[Queneau 2016] Press Therm Climat 2016;153:9-24
Learn more about this trial
Assessment of the Effect of Spa Therapy on the Quality of Life of Patients With Chronic Venous Insufficiency (NEYRAC)
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