BalneologyPhase 3NCT01956318
Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency
A Phase 3 study testing Crenobalneotherapy in people with Balneology, run by Centre de Recherche Rhumatologique et Thermal.
Trial summary
At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Balneology
- What is being tested?
- Crenobalneotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Feb 2012
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
- Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months
Who cannot join
- pregnant women,
- contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
- surgery in the next three months,
- spa treatment in the previous 6 months,
- professional involvement with a spa resort
About this study
Official title: Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.
- Conditions
- Balneology
- Being tested
- Crenobalneotherapy
- Keywords
- Chronic venous insufficiency, Varicose vein, Crenobalneotherapy, Balneotherapy, Spa therapy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenobalneotherapyBehavioural
Also called Crenotherapy, Balneotherapy, Spa therapy
18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.
| Study group | Role | What they receive |
|---|---|---|
| Crenobalneotherapy | Experimental | 18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle. Receives: Behavioral: Crenobalneotherapy |
| control group | No intervention | patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with 20% improvement of CIVIC scale at 3 months
Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months
Measured: 3 months
Secondary outcomes (7)
CIVIC
Chronic Venous Insufficiency Questionnaire (CIVIQ 2) 20% improvement. disease-specific QOL score for patients with chronic venous disease. The total score is derived from 20 questions (items) that represent four QOL dimensions (of 3-9 items each): bodily pain, physical, social and psychological functioning. The possible scores for each item are as follows: 1, negative; 2, weak; 3, moderate; 4, strong; 5, severe. The total scores can therefore vary from 20 (no symptoms) to 100 (worse possible condition).
Measured: 1 month
civic
evolution of civic scale
Measured: 1 & 3 months
Rutherford severity score
clinical evaluation of severity taking into account 10 attributes: pain, varicose veins, venous edema, skin pigmentation, and adherence to compressive therapy, inflammation, induration, number, size and duration of active ulcer. Each attribute is scored 0 (minimum) to 2 (maximum).
Measured: 1 & 3 months
PASS
PASS is measured by asking the patient if he/she feels he/she is in an acceptable clinical condition in terms of its venous insufficiency. We measure the number of patients with PASS
Measured: 1 & 3 months
opinion of patient and practitionner
Opinion of patient and practitioner is determined on a 5 point Lickert scale (very aggravated, aggravated, unchanged, improved and very improved)
Measured: 1 & 3 months
associated treatment
Drug consumption is estimated on the last 3 days prior to the evaluation. Surgery, hospitalization for venous insufficiency and adherence to compression therapy
Measured: 1 & 3 months
side effects
side effects are collected by therapists and assessor. we collected the number of patients with side effects and the type of side effect
Measured: week 1 & 3. 1 & 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalneologyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Rhumatologique et Thermal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FORESTIER Romain, Centre de Recherche Rhumatologique et Thermal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956318
- Sponsor's protocol ID
- Thermes2010
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Forestier RJ, Briancon G, Francon A, Erol FB, Mollard JM. Balneohydrotherapy in the treatment of chronic venous insufficiency. Vasa. 2014 Sep;43(5):365-71. doi: 10.1024/0301-1526/a000374.
PubMed 25147013
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01956318
- Acronym / sponsor ID
- Thermes2010
- Conditions
- Balneology
- Keywords
- Chronic venous insufficiency, Varicose vein, Crenobalneotherapy, Balneotherapy, Spa therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre de Recherche Rhumatologique et ThermalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crenobalneotherapy | Experimental | Behavioral: Crenobalneotherapy18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle. |
| control group | No intervention | –patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
- Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months
Key exclusion criteria (5 listed)
- pregnant women,
- contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
- surgery in the next three months,
- spa treatment in the previous 6 months,
- professional involvement with a spa resort
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 |
|---|---|---|
| CrenobalneotherapyAlso: Crenotherapy, Balneotherapy, Spa therapy18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center. | Behavioural | Crenobalneotherapy |
Primary outcome
number of patient with 20% improvement of CIVIC scale at 3 months
Time frame: 3 months
Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months
7 secondary outcomes
CIVIC
Time frame: 1 month
civic
Time frame: 1 & 3 months
Rutherford severity score
Time frame: 1 & 3 months
PASS
Time frame: 1 & 3 months
opinion of patient and practitionner
Time frame: 1 & 3 months
associated treatment
Time frame: 1 & 3 months
side effects
Time frame: week 1 & 3. 1 & 3 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 8 Oct 2013.
- Derived from this study: PubMed 25147013Forestier RJ, Briancon G, Francon A, Erol FB, Mollard JM. Balneohydrotherapy in the treatment of chronic venous insufficiency. Vasa. 2014 Sep;43(5):365-71. doi: 10.1024/0301-1526/a000374.
Related trials for Balneology
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crenobalneotherapy in people with Balneology, run by Centre de Recherche Rhumatologique et Thermal.
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 2 inclusion and 5 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of patient with 20% improvement of CIVIC scale at 3 months (time frame: 3 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 NCT01956318, which also lists 1 linked publication.
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 8 Oct 2013.