Chronic Venous InsufficiencyNEYRACNCT05449743
Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)
A study testing Spa therapy in people with Chronic Venous Insufficiency, run by Le Syndicat Intercommunal pour le Thermalisme et l'Environnement at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jul 2022to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Grenoble Alpes
Grenoble, 38043
Laboratoire TIMC
Grenoble, 38043
About this study
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
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
Read the 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
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Spa therapy
- Keywords
- spa therapy, phlebology, chronic venous insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapyOther
Also called spa treatment, spa care
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Spa therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start11 Jul 2022
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before / after study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis, University Grenoble Alps, thermes de NEYRAC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449743
- Sponsor's protocol ID
- 2021-A00545-36
- Acronym
- NEYRAC
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33757637Carpentier 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.
PubMed 24135621Launois 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.
PubMed 26993844Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Bellamy 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.
PubMed 3068365
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05449743
- Acronym / sponsor ID
- NEYRAC / 2021-A00545-36
- Conditions
- Chronic Venous Insufficiency
- Keywords
- spa therapy, phlebology, chronic venous insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Le Syndicat Intercommunal pour le Thermalisme et l'EnvironnementUniversity, hospital or other
- Collaborators
- Floralis, University Grenoble Alps, thermes de NEYRAC
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before / after study
| Arm | Type | Receives |
|---|---|---|
| patient treated with a phlebology-oriented spa therapy | Experimental | Other: Spa therapyThermal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapyAlso: spa treatment, spa careThermal 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 | patient treated with a phlebology-oriented spa therapy |
Primary outcome
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
Time frame: 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.
15 secondary outcomes
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
Time frame: 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).
Time frame: 3 and 6 months
Physician/Patient perception
Time frame: 3 and 6 months
Medication consumption
Time frame: 6 months
Assessment of compression compliance
Time frame: 3 and 6 months
Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category
Time frame: 3 and 6 months
Evolution of the general clinical criteria : Body Mass Index (BMI)
Time frame: 3 and 6 months
Evolution of the general clinical criteria : systolic blood pressure
Time frame: 3 and 6 months
Evolution of the general clinical criteria : diastolic blood pressure
Time frame: 3 and 6 months
Evolution of the general clinical criteria : heart rate
Time frame: 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
Time frame: 3 and 6 months
Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment
Time frame: 6 months
Evaluation of compliance with the spa therapy
Time frame: 3 weeks
Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time frame: 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)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 33757637Kim 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.
- Background: PubMed 24135621Carpentier 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.
- Background: PubMed 26993844Launois 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.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 3068365Bellamy 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.
- \[Anaes 1999\] 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 1999Link provided by the sponsor.
- \[Queneau 2016\] Press Therm Climat 2016;153:9-24Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy in people with Chronic Venous Insufficiency, run by Le Syndicat Intercommunal pour le Thermalisme et l'Environnement at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449743, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.