Knee Osteoarthritis, Knee Osteoarthritis (OA)
Conditions
Keywords
Balneotherapy, Spa therapy, Rheumatology, Knee osteoarthritis, WOMAC
Brief 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 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.
Interventions
OTHERBalneotherapy program in rheumatology indication
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.
Sponsors
COMPAGNIE EUROPEENNE DES BAINS
VALVITAL Santenay
CEN Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, single-arm, superiority study with external comparison (control group of a reference RCT)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Clinically Important Improvement (MCII) at 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of pain-related knee osteoarthritis at 3 months | Day 1 and 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). |
| Change from baseline of pain-related knee osteoarthritis at 6 months | Day 1 and 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). |
| Change from baseline of the pain subscale of the WOMAC at 3 months | Day 1 and 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). |
| Change from baseline of the pain subscale of the WOMAC at 6 months | Day 1 and 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). |
| Changes from baseline of stiffness subscale of the WOMAC at 3 months | Day 1 and 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). |
| Changes from baseline of stiffness subscale of the WOMAC at 6 months | Day 1 and 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). |
| Change from baseline of physical function subscale of the WOMAC at 3 months | Day 1 and 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). |
| Change from baseline of physical function subscale of the WOMAC at 6 months | Day 1 and 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). |
| Change from baseline of total score of the WOMAC at 3 months | Day 1 and 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). |
| Change from baseline of total score of the WOMAC at 6 months | Day 1 and 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). |
| Acceptable Symptom State (ASS) at 3 months | 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). |
| Acceptable Symptom State (ASS) at 6 months | 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). |
| Changes from baseline of quality of life at 3 months | Day 1 and 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). |
| Changes from baseline of quality of life at 6 months | Day 1 and 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). |
| Management of knee osteoarthritis over the study | 6 months | 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). |
| Safety of the18-day balneotherapy program (therapeutic indication: Rheumatology) at Santenay | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the spa therapy and spa site | Day 18 | Subjective opinion of patients regarding spa cares, facilities and staff, is collected at the end of the program, and measured using a 5-point Likert scale. |
Countries
France
Contacts
Primary ContactChristine JUHEL, Ph.D
Backup ContactAmandine FRY
Outcome results
None listed