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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00448-41 | Other Identifier | French Competent Authority (ANSM) |
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| Name | Class |
|---|---|
| Town Hall of Enghien-les-Bains | UNKNOWN |
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The goal of this interventional study is to evaluate the effectiveness at 6 months of the Enghien-les-Bains thermal spa treatment on functional disability and pain, assessed by the Minimal Clinically Important Improvement (MCII), in patients with knee osteoarthritis.
The study is conducted in patients aged 50 to 80 years with knee osteoarthritis (Kellgren-Lawrence grade 2 to 4) and a baseline functional impairment defined by a normalized WOMAC function score ≥ 30.
The main questions it aims to answer are:
Patients of the study:
This study includes three medical visits with the investigator: one within 28 days before the thermal spa treatment, one at the end of the treatment, and one 6 months after the start of the treatment. At inclusion, informed consent is obtained, eligibility criteria are verified, and baseline data are collected, including self-administered questionnaires assessing pain, function, and quality of life before the start of the treatment.
During the 20-day thermal spa treatment, care provided and any adverse events are recorded. Clinical assessments and questionnaires are repeated at the end of the treatment. Additional patient-reported outcomes and treatment changes are collected at 3 months, and a final clinical evaluation and questionnaires are completed at 6 months.
An ancillary qualitative study evaluates the conditions under which the thermal spa treatment program is effective from the participants' perspective, including their engagement, lived experience, perceived benefits, facilitators and barriers, and any adaptations made. Data are collected through individual semi-structured face-to-face interviews at the end of the treatment, which are audio-recorded, fully transcribed, and qualitatively analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal spa treatment | Experimental | 18-day spa program with Waters of Enghien-les-Bains in addition to standard of care for knee osteoarthritis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal spa sessions | Other | At least 4 spa sessions per day, 6 days a week during 3 consecutive weeks that may include daily: one whirlpool bath, one poultice application, one overall jet shower and one underwater massage with thermal water. With the exception of the application of mud poultices and whirlpool bath, which cannot be substituted, other treatments may be replaced by: immersion bath with shower, penetrating shower, and local jet shower. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied for 10 minutes as a poultice to both knees (minimum 2 per knee, 45°C), if necessary, to other painful osteoarthritis areas. A 3-minute overall jet shower is administered by a thermal spa staff member, using thermal water at 37°C. A 10-minute underwater massage is administered by a physiotherapist, under a thermal water spray bar at 37°C. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of pain-related knee osteoarthritis at 20 days | 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). | Day 1 and 20 days |
| Change from baseline of pain-related knee osteoarthritis at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative assessment of participant experience and engagement with the thermal spa treatment | Semi-structured individual interviews are conducted with a subset of participants to explore their level of engagement, lived experience, and perceived benefits of the thermal spa treatment. The interviews also assess facilitators and barriers encountered during participation, as well as any adaptations made by participants, from their own perspective. Interview data are analyzed using qualitative thematic analysis. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Juhel, Ph.D | Contact | +33380680511 | christine.juhel@groupecen.com | |
| Amandine Fry | Contact | +33380680513 | amandine.fry@groupecen.com |
| Name | Affiliation | Role |
|---|---|---|
| Magali Ballard, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thermes d'Enghien-les-Bains | Recruiting | Enghien-les-Bains | 95880 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40358707 | Background | Forestier R, Debiais F, Michel N, Schueller R, Juhel C. The effectiveness of a 3-week spa therapy on the 6-month mobility and functional ability of patients with knee osteoarthritis: the ANGELLO randomized controlled trial. Int J Biometeorol. 2025 Jul;69(7):1715-1724. doi: 10.1007/s00484-025-02927-2. Epub 2025 May 13. |
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The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014876 | Water Pollution |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004787 | Environmental Pollution |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019984 | Quality Indicators, Health Care |
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Prospective, single-arm, superiority study with external comparison (control group of a reference RCT)
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| Thermal water | Other | The water has a neutral pH (7), is cold (14 °C), and presents a moderate level of mineralization (571 mg/L) with a balanced ionic profile. It contains calcium (128 mg/L), bicarbonates (440 mg/L), sulfates (93 mg/L), magnesium (27.9 mg/L), and sodium (12.4 mg/L). |
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| Standard of Care for Knee Osteoarthritis | Other | Participants continue standard medical care for knee osteoarthritis as prescribed by their primary care physician, including analgesics and physiotherapy, according to routine clinical practice. |
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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). |
| 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). | Day 1 and 6 months |
| Change from baseline of the pain subscale of the WOMAC at 20 days | 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). | Day 1 and 20 days |
| 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). | 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). | Day 1 and 6 months |
| Changes from baseline of stiffness subscale of the WOMAC at 20 days | 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). | Day 1 and 20 days |
| 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). | 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). | Day 1 and 6 months |
| Change from baseline of physical function subscale of the WOMAC at 20 days | 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). | Day 1 and 20 days |
| 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). | Day 1 and 3 months |
| Change from baseline of physical function subscale of the WOMAC at 36 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). | Day 1 and 6 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). | Day 1 and 6 months |
| Change from baseline of total score of the WOMAC at 20 days | 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). | Day 1 and 20 days |
| 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). | Day 1 and 6 months |
| Changes from baseline of quality of life at 20 days | 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). | Day 1 and 20 days |
| 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). | 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 patient health state. Mean variation is compared with that of the control group in the reference RCT (external comparison). | Day 1 and 6 months |
| Acceptable Symptom State (ASS) at 20 days | 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). | Day 20 |
| 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). | 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). | 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). | 6 months |
| Safety of the18-day spa treatment (therapeutic indication: Rheumatology) at Enghien-les-Bains | Adverse effects related to the spa treatment are described using MedDRA, whether they occurred during or after the 18-day spa treatment. | 6 months |
| Day 20 |
| Thermes d'Enghien-les-Bains | Not yet recruiting | Enghien-les-Bains | Île-de-France Region | 95880 | France |
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| D012216 |
| Rheumatic Diseases |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |