Centre thermal de Saint-Lary Soulan
Saint-Lary-Soulan, 65170, France
NCT Number: NCT05790824
The hypothesis is that the use of spa therapy in Saint-Lary Soulan for knee osteoarthritis treatment would have a therapeutic effect on this pathology.
The main objective of this external comparison study is to evaluate the comparative effectiveness at 6 months of spa therapy in the Saint-Lary Soulan spa center on functional disability and pain (MCII: Minimal Clinical Important Improvement) in knee osteoarthritis compared to the control group of the Thermarthrose multicenter randomized clinical trial, receiving standard cares.
The patients included in the Larytherm cohort will undergo a three-week spa therapy in Saint-Lary Soulan with a follow-up of 6 months after the end of spa therapy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint-Lary-Soulan, 65170, France
Knee osteoarthritis is a frequent disease with important consequences for quality of life of patients. In France, prevalence was estimated at 7.6% among subjects between 40-75 years old. The management of knee osteoarthritis is essentially based on lifestyle and dietary measures and the use of analgesic treatment. Spa treatments are also part of the overall management of this pathology.
In this context, the spa town Saint-Lary Soulan requests the approval of the " Rheumatology " therapeutic orientation for its new borehole water (SL5), which requires a study (Larytherm) conducted according to the criteria of the French Academy of Medicine.
Secondary objectives are to evaluate 6 months after spa therapy in Saint-Lary Soulan, the evolution of:
The patients will be identified by local physicians or through a local public communication campaign. The patients with criteria of eligibility will complete a self-reported questionnaire before the beginning of spa therapy, after the spa therapy and 6 months after the end of spa therapy, and the physicians practising at the spa center will complete a medical questionnaire at inclusion and after the spa therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The "RH2" rheumatology treatment protocol will propose treatments that can be carried out with water from the SL5 borehole and will be composed of:
Time frame: 6 months after the end of spa therapy
Improvement from baseline of at least 9.1 points on the Western Ontario and McMaster University osteoarthritis (WOMAC) index standardized functional subscale of 0-100 and/or at least 1.99 cm on the Visual Analogue Scale (VAS) for pain without knee surgery, at 6 months.
WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain.
This outcome will be evaluated in the Larytherm cohort and compared to the control group of the Thermarthrose study.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
WOMAC index (full questionnaire): functional assessment index for knee osteoarthritis, exploring three areas of analysis: pain, stiffness and daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of the spa therapy
Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Visual Analogue Scale for the evaluation of fatigue on the day of filling out the self-questionnaire.The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no fatigue and the right end (= 10 cm) to the maximum imaginable fatigue.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Questionnaire to assess the functional abilities and discomfort experienced by patients with knee osteoarthritis. Each question is scored, and the final score is classified as follows: 0-4: modest disability, 5-7: moderate disability, 8-10 points: significant disability, 11-13 points: very significant disability, ≥14 points: unbearable extreme disability.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Quality of life questionnaire exploring 8 dimensions of quality of life and calculating two Summary Psychological and Physical Scores, ranging from 0 (no quality of life) to 100 (maximum quality of life).
Time frame: Baseline and 6 months after the end of spa therapy
Time frame: Baseline and 6 months after the end of spa therapy
The patient self-questionnaire includes yes/no questions and pre-listed options.
Time frame: Baseline and 6 months after the end of spa therapy
Questionnaire for the assessment of physical activity performed for at least 10 minutes in a row during the last 7 days, including questions on heavy lifting. The score is expressed in metabolic equivalent task (MET-minutes/week) or categorically in 3 levels (low/moderate/high)
Time frame: 6 months after the end of spa therapy
Time frame: End of spa therapy (week 3) and 6 months after the end of spa therapy
Time frame: 6 months after the end of spa therapy
University of Bordeaux
Other
Acronym: LARYTHERM
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