Knee OsteoarthritisSANTIAGONCT06617975
Knee Osteoarthritis and Spa Therapy
A study testing Balneotherapy program in rheumatology indication in people with Knee Osteoarthritis and Knee Osteoarthritis (OA), run by CEN Biotech at 1 site in France.
Trial summary
The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Osteoarthritis (OA)
- What is being tested?
- Balneotherapy program in rheumatology indication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years.
- 100-normalized score of the WOMAC physical function subscale greater than or equal to 30.
- Accepting a prescription for a balneotherapy program in the Rheumatology at Santenay spa as part of the management of their knee osteoarthritis issued by the investigator.
- Signed inform consent.
- With health insurance affiliation.
Who cannot join
- Presented with balneotherapy contraindication or to certain adjuvant treatment techniques (balneation, hydrotherapy jets, massage): chronic infectious pathology, active cancer, decompensated cardiac, hepatic or renal insufficiency, "open" leg ulcer, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, behavioral disorders, etc.
- Presented with chronic pain for reasons other than osteoarthritis: chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis) or fibromyalgia.
- Having had spa treatment in the past 6 months whatever the indication or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months.
- Having planned a spa treatment in another indication between inclusion and final visit.
- Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months.
- Residing more than 30 kilometers from Santenay at the time of spa treatment. Women of childbearing potential who are not using effective contraception (estrogen/progestin or progestin-only oral, vaginal, transdermal, injectable or subcutaneous) or who plan to discontinue contraception within the next 7 months.
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- Likely to be unable to comply with protocol or to attend visits, particularly in view of the duration of the research, or unable to read or understand French.
- Regulatory reason (guardianship or already enrolled in a clinical trial).
- Already included in a clinical trial or in the exclusion period of a clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Valvital - Thermes de Santenay
Santenay, Burgundy, 21590
Olivier BRUEZ, +330643194992, olivier.bruez@valvital.com
About this study
Official title: Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis
The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented with knee osteoarthritis.
The French National Academy of Medicine encourages the re-use of RCT data when available. In this context, the current study is designed as a single-arm prospective study with external comparison using the propensity score. The Control group consists of the patients which were allocated to the Control group of reference randomized clinical trial (RCT) "ANGELLO Study" (NCT05819437). These patients received standard care for knee osteoarthritis, i.e., pain management and exercise recommendations.
All patients enrolled in the current study benefit of 18-day balneotherapy program (therapeutic indication: Rheumatology) with Mineral Water of Santenay (Burgundy, France), and examination with a practitioner at enrollment and 6 months after the beginning of spa treatment.
Read the detailed description
For study purposes, two medical visits with the investigator are organized: the first in the 28 days preceding the 18-day balneotherapy program, or at the latest on the first day of the program, before the first care, and the second 6 months after the start of the program. A remote visit at 3 months is also organized.
The data required for study evaluations are collected by the investigator or self-evaluated by patients during the visits.
Patients of the study receive the same exercise recommendations than the patients of the Control group of the reference study, and their body weight as well as physical ability are monitored.
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (OA)
- Being tested
- Balneotherapy program in rheumatology indication
- Keywords
- Balneotherapy, Spa therapy, Rheumatology, Knee osteoarthritis, WOMAC
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balneotherapy program in rheumatology indicationOther
At least 4 balneotherapy sessions per day, 6 days a week during 3 consecutive weeks that may include: 1 whirlpool bath per day, 1 poultice application per day, 1 bath with immersion showers in a pool per day, a local jet shower every other day, a penetrating shower every other day.
Alternative treatments may replace penetrating shower or local jet shower, or other care, e.g., collective jet shower or steam bath. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied 10 minutes as a poultice to both knees (minimum 2 per knee, 52°C), if necessary, to other painful osteoarthritis areas. 10-minute collective pool bathing takes place in a thermal pool equipped with jet stations immersed in water at 32°C. 3-minute local jet shower is applied to the predefined area using thermal water at 37°C. 10-minute penetrating showers are delivered by an affusion ramp on the patient lying down and directed on the area defined, using thermal water at 37°C.
| Study group | Role | What they receive |
|---|---|---|
| Balneotherapy | Experimental | 18-day balneotherapy program with Mineral Water of Santenay in addition to standard of care for knee osteoarthritis Receives: Other: Balneotherapy program in rheumatology indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Clinically Important Improvement (MCII) at 6 months
MCII is defined as a pain reduction of 19.9 mm or more on a 0-100 visual analogic scale (VAS), where 0 means no pain and 100 worse pain.
The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).
Measured: 6 months
Minimal Clinically Important Improvement (MCII) at 6 months
MCII is defined as a reduction of 9.1 points or more in the function subscale of the Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) in absence of knee surgery. WOMAC is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations).
The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).
Measured: 6 months
Secondary outcomes (16)
Change from baseline of pain-related knee osteoarthritis at 3 months
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 3 months
Change from baseline of pain-related knee osteoarthritis at 6 months
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 6 months
Change from baseline of the pain subscale of the WOMAC at 3 months
Pain subscale of the WOMAC is a self-administered questionnaire that consists in 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse pain limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 3 months
Change from baseline of the pain subscale of the WOMAC at 6 months
Pain subscale of the WOMAC is a self-administered questionnaire that consists in 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse pain limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 6 months
Changes from baseline of stiffness subscale of the WOMAC at 3 months
Stiffness subscale of the WOMAC is a self-administered questionnaire that consists in 2 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse stiffness limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 3 months
Changes from baseline of stiffness subscale of the WOMAC at 6 months
Stiffness subscale of the WOMAC is a self-administered questionnaire that consists in 2 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse stiffness limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 6 months
Change from baseline of physical function subscale of the WOMAC at 3 months
Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 3 months
Change from baseline of physical function subscale of the WOMAC at 6 months
Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 6 months
Change from baseline of total score of the WOMAC at 3 months
The scores for each of the 3 subscales (function, pain, stiffness) are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).
Measured: Day 1 and 3 months
Change from baseline of total score of the WOMAC at 6 months
The scores for each of the 3 subscales (function, pain, stiffness) are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).
Measured: Day 1 and 6 months
Acceptable Symptom State (ASS) at 3 months
ASS is defined as VAS pain value of 32 mm or less or a WOMAC function subscale, normalized to a 0-100 score of 31 points or less. The percentage of patients achieving ASS is calculated and compared with that of the control group in the reference RCT (external comparison).
Measured: 3 months
Acceptable Symptom State (ASS) at 6 months
ASS is defined as VAS pain value of 32 mm or less or a WOMAC function subscale, normalized to a 0-100 score of 31 points or less. The percentage of patients achieving ASS is calculated and compared with that of the control group in the reference RCT (external comparison).
Measured: 6 months
Changes from baseline of quality of life at 3 months
Quality of life is measured using EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes patient health state. Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 3 months
Changes from baseline of quality of life at 6 months
Quality of life is measured using EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient health state. Mean variation is compared with that of the control group in the reference RCT (external comparison).
Measured: Day 1 and 6 months
Management of knee osteoarthritis over the study
Number and frequency of treatments for knee osteoarthritis (analgesics, chondro-protectors or antarthritics, intra-articular injections of corticoids and hyaluronic acid, physical or surgical treatments). Numbers and frequencies of treatments are compared with those of the control group in the reference RCT (external comparison).
Measured: 6 months
Safety of the18-day balneotherapy program (therapeutic indication: Rheumatology) at Santenay
Adverse effects related to the 18-day balneotherapy program (therapeutic indication: Rheumatology) with Santenay mineral water are described using MedDRA, whether they occurred during or after the program.
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 posted1 Oct 2024
- Study start14 Oct 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, superiority study with external comparison (control group of a reference RCT)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COMPAGNIE EUROPEENNE DES BAINS, VALVITAL Santenay
- Responsible party
- Sponsor
- Investigators
- Bruno COLLOMBIER, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617975
- Sponsor's protocol ID
- C1729
- Acronym
- SANTIAGO
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data is not anonymized. To comply with European regulations and national provisions, patients are informed that no sharing of IPD is planned in order to protect their personal data. If data is to be shared, patients must be informed individually and their consent obtained. At this stage, only aggregated data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06617975
- Acronym / sponsor ID
- SANTIAGO / C1729
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (OA)
- Keywords
- Balneotherapy, Spa therapy, Rheumatology, Knee osteoarthritis, WOMAC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- COMPAGNIE EUROPEENNE DES BAINS, VALVITAL Santenay
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented with knee osteoarthritis.
The French National Academy of Medicine encourages the re-use of RCT data when available. In this context, the current study is designed as a single-arm prospective study with external comparison using the propensity score. The Control group consists of the patients which were allocated to the Control group of reference randomized clinical trial (RCT) "ANGELLO Study" (NCT05819437). These patients received standard care for knee osteoarthritis, i.e., pain management and exercise recommendations.
All patients enrolled in the current study benefit of 18-day balneotherapy program (therapeutic indication: Rheumatology) with Mineral Water of Santenay (Burgundy, France), and examination with a practitioner at enrollment and 6 months after the beginning of spa treatment.
Detailed description
For study purposes, two medical visits with the investigator are organized: the first in the 28 days preceding the 18-day balneotherapy program, or at the latest on the first day of the program, before the first care, and the second 6 months after the start of the program. A remote visit at 3 months is also organized.
The data required for study evaluations are collected by the investigator or self-evaluated by patients during the visits.
Patients of the study receive the same exercise recommendations than the patients of the Control group of the reference study, and their body weight as well as physical ability are monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, superiority study with external comparison (control group of a reference RCT)
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy | Experimental | Other: Balneotherapy program in rheumatology indication18-day balneotherapy program with Mineral Water of Santenay in addition to standard of care for knee osteoarthritis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years.
- 100-normalized score of the WOMAC physical function subscale greater than or equal to 30.
- Accepting a prescription for a balneotherapy program in the Rheumatology at Santenay spa as part of the management of their knee osteoarthritis issued by the investigator.
- Signed inform consent.
- With health insurance affiliation.
Key exclusion criteria (9 listed)
- Presented with balneotherapy contraindication or to certain adjuvant treatment techniques (balneation, hydrotherapy jets, massage): chronic infectious pathology, active cancer, decompensated cardiac, hepatic or renal insufficiency, "open" leg ulcer, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, behavioral disorders, etc.
- Presented with chronic pain for reasons other than osteoarthritis: chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis) or fibromyalgia.
- Having had spa treatment in the past 6 months whatever the indication or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months.
- Having planned a spa treatment in another indication between inclusion and final visit.
- Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months.
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 |
|---|---|---|
| Balneotherapy program in rheumatology indicationAt least 4 balneotherapy sessions per day, 6 days a week during 3 consecutive weeks that may include: 1 whirlpool bath per day, 1 poultice application per day, 1 bath with immersion showers in a pool per day, a local jet shower every other day, a penetrating shower every other day. Alternative treatments may replace penetrating shower or local jet shower, or other care, e.g., collective jet shower or steam bath. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied 10 minutes as a poultice to both knees (minimum 2 per knee, 52°C), if necessary, to other painful osteoarthritis areas. 10-minute collective pool bathing takes place in a thermal pool equipped with jet stations immersed in water at 32°C. 3-minute local jet shower is applied to the predefined area using thermal water at 37°C. 10-minute penetrating showers are delivered by an affusion ramp on the patient lying down and directed on the area defined, using thermal water at 37°C. | Other | Balneotherapy |
Primary outcome
Minimal Clinically Important Improvement (MCII) at 6 months
Time frame: 6 months
MCII is defined as a pain reduction of 19.9 mm or more on a 0-100 visual analogic scale (VAS), where 0 means no pain and 100 worse pain. The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).
Minimal Clinically Important Improvement (MCII) at 6 months
Time frame: 6 months
MCII is defined as a reduction of 9.1 points or more in the function subscale of the Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) in absence of knee surgery. WOMAC is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations). The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).
16 secondary outcomes
Change from baseline of pain-related knee osteoarthritis at 3 months
Time frame: Day 1 and 3 months
Change from baseline of pain-related knee osteoarthritis at 6 months
Time frame: Day 1 and 6 months
Change from baseline of the pain subscale of the WOMAC at 3 months
Time frame: Day 1 and 3 months
Change from baseline of the pain subscale of the WOMAC at 6 months
Time frame: Day 1 and 6 months
Changes from baseline of stiffness subscale of the WOMAC at 3 months
Time frame: Day 1 and 3 months
Changes from baseline of stiffness subscale of the WOMAC at 6 months
Time frame: Day 1 and 6 months
Change from baseline of physical function subscale of the WOMAC at 3 months
Time frame: Day 1 and 3 months
Change from baseline of physical function subscale of the WOMAC at 6 months
Time frame: Day 1 and 6 months
Change from baseline of total score of the WOMAC at 3 months
Time frame: Day 1 and 3 months
Change from baseline of total score of the WOMAC at 6 months
Time frame: Day 1 and 6 months
Acceptable Symptom State (ASS) at 3 months
Time frame: 3 months
Acceptable Symptom State (ASS) at 6 months
Time frame: 6 months
Changes from baseline of quality of life at 3 months
Time frame: Day 1 and 3 months
Changes from baseline of quality of life at 6 months
Time frame: Day 1 and 6 months
Management of knee osteoarthritis over the study
Time frame: 6 months
Safety of the18-day balneotherapy program (therapeutic indication: Rheumatology) at Santenay
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- ANGELLO STUDYLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Patient data is not anonymized. To comply with European regulations and national provisions, patients are informed that no sharing of IPD is planned in order to protect their personal data. If data is to be shared, patients must be informed individually and their consent obtained. At this stage, only aggregated data can be shared.
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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.
Bruno COLLOMBIER, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balneotherapy program in rheumatology indication in people with Knee Osteoarthritis and Knee Osteoarthritis (OA), run by CEN Biotech at 1 site 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine JUHEL, Ph.D (+33380680511, christine.juhel@groupecen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Clinically Important Improvement (MCII) at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.