Knee Osteoarthritis and Spa Therapy

Официальное название

Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Balneotherapy 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

Первичные конечные точки

• Minimal Clinically Important Improvement (MCII) at 6 months [Срок оценки: 6 months]
• Minimal Clinically Important Improvement (MCII) at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Change from baseline of pain-related knee osteoarthritis at 3 months [Срок оценки: Day 1 and 3 months]
• Change from baseline of pain-related knee osteoarthritis at 6 months [Срок оценки: Day 1 and 6 months]
• Change from baseline of the pain subscale of the WOMAC at 3 months [Срок оценки: Day 1 and 3 months]
• Change from baseline of the pain subscale of the WOMAC at 6 months [Срок оценки: Day 1 and 6 months]
• Changes from baseline of stiffness subscale of the WOMAC at 3 months [Срок оценки: Day 1 and 3 months]
• Changes from baseline of stiffness subscale of the WOMAC at 6 months [Срок оценки: Day 1 and 6 months]
• Change from baseline of physical function subscale of the WOMAC at 3 months [Срок оценки: Day 1 and 3 months]
• Change from baseline of physical function subscale of the WOMAC at 6 months [Срок оценки: Day 1 and 6 months]
• Change from baseline of total score of the WOMAC at 3 months [Срок оценки: Day 1 and 3 months]
• Change from baseline of total score of the WOMAC at 6 months [Срок оценки: Day 1 and 6 months]
• Acceptable Symptom State (ASS) at 3 months [Срок оценки: 3 months]
• Acceptable Symptom State (ASS) at 6 months [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Valvital - Thermes de Santenay — Santenay

Идентификаторы

NCT: NCT06617975 · C1729

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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