Knee OsteoarthritisANGELLONCT05819437
Knee Osteoarthritis and Balneotherapy
A study testing Balneotherapy program in people with Knee Osteoarthritis, run by CEN Biotech at 1 site in France.
Trial summary
The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness)… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Balneotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2020to 20 Sep 2022
- 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 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 of 30 or greater;
- Available for balneotherapy program and the 6-month study follow-up;
- Signed inform consent;
- with health insurance affiliation.
Who cannot join
- Presented with balneotherapy contra-indication;
- Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
- Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
- regulatory reason (guardianship or already enrolled in a clinical trial).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone
The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.
Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.
Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.
- Conditions
- Knee Osteoarthritis
- Being tested
- Balneotherapy program
- Keywords
- Balneotherapy, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balneotherapy programOther
Whirlpool bath, bath with immersion showers, poultice application and underwater massage.
The baths were performed in an individual tub in ten-minute sessions. The temperature was set specifically for each patient, on average from 34 to 38°C. These were baths with jets and air diffusion.
The mud was applied as a poultice to the 2 knees and if necessary (duration of application: 10 minutes).
The massages were carried out by qualified physiotherapists under an affusion ramp of thermal water at 38°C for 10 minutes.
The water used is a mixed sulphated Natural Mineral Water, collected by drilling the "capuchins" at a depth of 975 m. The temperature of the water at the outlet of the borehole is 41.8°C and is lowered to 35°C.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | Standard of care for knee osteoarthritis |
| BALNEOTHERAPY PROGRAM | Experimental | 3-week balneotherapy program with Mineral Water of Saint Jean d'Angely in addition to standard of care for knee osteoarthritis Receives: Other: Balneotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation from baseline in 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).
Measured: Baseline (D1) and final (6 months)
Secondary outcomes (17)
Variation from baseline in 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).
Measured: Baseline (D1) and final (3 months)
Variation from baseline in 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).
Measured: Baseline (D1) and final (3 months)
Variation from baseline in 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).
Measured: Baseline (D1) and final (6 months)
Variation from baseline in 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).
Measured: Baseline (D1) and final (3 months)
Variation from baseline in 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).
Measured: Baseline (D1) and final (6 months)
Variation from baseline in WOMAC total score at 3 months
The scores for each subscale are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).
Measured: Baseline (D1) and final (3 months)
Variation from baseline in WOMAC total score at 6 months
The scores for each subscale are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).
Measured: Baseline (D1) and final (6 months)
Variation from baseline in pain-induced knee osteoarthritis intensity at 3 months
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
Measured: Baseline (D1) and final (3 months)
Variation from baseline in pain-induced knee osteoarthritis intensity at 6 months
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
Measured: Baseline (D1) and final (6 months)
Number of participants achieving minimal clinically important improvement (MCII) at 3 months
MCII is defined as 19.9 mm or greater on the VAS pain scale and/or 9.1 points or greater on the WOMAC physical function subscale normalized to a 0-100 score, and no knee surgery
Measured: 3 months
Number of participants achieving minimal clinically important improvement (MCII) at 6 months
MCII is defined as 19.9 mm or greater on the VAS pain scale and/or 9.1 points or greater on the WOMAC physical function subscale normalized to a 0-100 score, and no knee surgery
Measured: 6 months
Number of participants presented with acceptable symptom state (ASS) at 3 months
ASS is defined as VAS pain 32 mm or less or WOMAC function subscale normalized to a 0-100 score of 31 points or less.
Measured: 3 months
Number of participants presented with acceptable symptom state (ASS) at 6 months
ASS is defined as VAS pain 32 mm or less or WOMAC function subscale normalized to a 0-100 score of 31 points or less.
Measured: 6 months
Changes in participants 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 the patient's health state.
Measured: 3 months
Changes in participants 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's health state.
Measured: 6 months
Frequency of adverse events throughout the study
Adverse events are described using MedDRA and each event frequency is calculated.
Measured: From inclusion to the final visit at 6 months
Participants' opinion with their symptoms related to knee osteoarthritis at 6 months
Opinion is measured using a 5-point Likert scale
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 posted19 Apr 2023
- Study start26 Aug 2020
- Primary completion3 Jul 2021
- Study completion20 Sep 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial, monocentric
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COMPAGNIE EUROPEENNE DES BAINS
- Responsible party
- Sponsor
- Investigators
- Arnaud TERRILLON-SEYTRE, Study director, CEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819437
- Sponsor's protocol ID
- C1650
- Acronym
- ANGELLO
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone
- ClinicalTrials.gov ID
- NCT05819437
- Acronym / sponsor ID
- ANGELLO / C1650
- Conditions
- Knee Osteoarthritis
- Keywords
- Balneotherapy, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- COMPAGNIE EUROPEENNE DES BAINS
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 19 Apr 2023 (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 goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.
Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.
Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled Trial, monocentric
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –Standard of care for knee osteoarthritis |
| BALNEOTHERAPY PROGRAM | Experimental | Other: Balneotherapy program3-week balneotherapy program with Mineral Water of Saint Jean d'Angely 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 of 30 or greater;
- Available for balneotherapy program and the 6-month study follow-up;
- Signed inform consent;
- with health insurance affiliation.
Key exclusion criteria (4 listed)
- Presented with balneotherapy contra-indication;
- Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
- Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
- regulatory reason (guardianship or already enrolled in a clinical trial).
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 programWhirlpool bath, bath with immersion showers, poultice application and underwater massage. The baths were performed in an individual tub in ten-minute sessions. The temperature was set specifically for each patient, on average from 34 to 38°C. These were baths with jets and air diffusion. The mud was applied as a poultice to the 2 knees and if necessary (duration of application: 10 minutes). The massages were carried out by qualified physiotherapists under an affusion ramp of thermal water at 38°C for 10 minutes. The water used is a mixed sulphated Natural Mineral Water, collected by drilling the "capuchins" at a depth of 975 m. The temperature of the water at the outlet of the borehole is 41.8°C and is lowered to 35°C. | Other | BALNEOTHERAPY PROGRAM |
Primary outcome
Variation from baseline in physical function subscale of the WOMAC at 6 months
Time frame: Baseline (D1) and final (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).
17 secondary outcomes
Variation from baseline in physical function subscale of the WOMAC at 3 months
Time frame: Baseline (D1) and final (3 months)
Variation from baseline in pain subscale of the WOMAC at 3 months
Time frame: Baseline (D1) and final (3 months)
Variation from baseline in pain subscale of the WOMAC at 6 months
Time frame: Baseline (D1) and final (6 months)
Variation from baseline in stiffness subscale of the WOMAC at 3 months
Time frame: Baseline (D1) and final (3 months)
Variation from baseline in stiffness subscale of the WOMAC at 6 months
Time frame: Baseline (D1) and final (6 months)
Variation from baseline in WOMAC total score at 3 months
Time frame: Baseline (D1) and final (3 months)
Variation from baseline in WOMAC total score at 6 months
Time frame: Baseline (D1) and final (6 months)
Variation from baseline in pain-induced knee osteoarthritis intensity at 3 months
Time frame: Baseline (D1) and final (3 months)
Variation from baseline in pain-induced knee osteoarthritis intensity at 6 months
Time frame: Baseline (D1) and final (6 months)
Number of participants achieving minimal clinically important improvement (MCII) at 3 months
Time frame: 3 months
Number of participants achieving minimal clinically important improvement (MCII) at 6 months
Time frame: 6 months
Number of participants presented with acceptable symptom state (ASS) at 3 months
Time frame: 3 months
Number of participants presented with acceptable symptom state (ASS) at 6 months
Time frame: 6 months
Changes in participants quality of life at 3 months
Time frame: 3 months
Changes in participants quality of life at 6 months
Time frame: 6 months
Frequency of adverse events throughout the study
Time frame: From inclusion to the final visit at 6 months
Participants' opinion with their symptoms related to knee osteoarthritis at 6 months
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 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Arnaud TERRILLON-SEYTRE study director
CEN
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 people with Knee Osteoarthritis, 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 4 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 Apr 2023. 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?
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?
Variation from baseline in physical function subscale of the WOMAC at 6 months (time frame: Baseline (D1) and final (6 months)). 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 19 Apr 2023.