Knee Osteoarthritis and Spa Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorCEN Biotech
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Balneotherapy program in rheumatology indication
Other interventionAt 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: BalneotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
6 months2
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).
Time frame
6 monthsSecondary outcomes
1
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).
Time frame
Day 1 and 3 months2
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).
Time frame
Day 1 and 6 months3
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).
Time frame
Day 1 and 3 months4
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).
Time frame
Day 1 and 6 monthsOther outcomes
1
Satisfaction with the spa therapy and spa site
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.
Time frame
Day 18Sponsors and contacts
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Source ClinicalTrials.gov