Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Minimal Clinically Important Improvement (MCII) at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Minimal Clinically Important Improvement (MCII) at 6 months
时间窗: 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).
次要结局
- Change from baseline of pain-related knee osteoarthritis at 3 months(Day 1 and 3 months)
- Change from baseline of pain-related knee osteoarthritis at 6 months(Day 1 and 6 months)
- Change from baseline of the pain subscale of the WOMAC at 3 months(Day 1 and 3 months)
- Change from baseline of the pain subscale of the WOMAC at 6 months(Day 1 and 6 months)
- Changes from baseline of stiffness subscale of the WOMAC at 3 months(Day 1 and 3 months)
- Changes from baseline of stiffness subscale of the WOMAC at 6 months(Day 1 and 6 months)
- Change from baseline of physical function subscale of the WOMAC at 3 months(Day 1 and 3 months)
- Change from baseline of physical function subscale of the WOMAC at 6 months(Day 1 and 6 months)
- Change from baseline of total score of the WOMAC at 3 months(Day 1 and 3 months)
- Change from baseline of total score of the WOMAC at 6 months(Day 1 and 6 months)
- Acceptable Symptom State (ASS) at 3 months(3 months)
- Acceptable Symptom State (ASS) at 6 months(6 months)
- Changes from baseline of quality of life at 3 months(Day 1 and 3 months)
- Changes from baseline of quality of life at 6 months(Day 1 and 6 months)
- Management of knee osteoarthritis over the study(6 months)
- Safety of the18-day balneotherapy program (therapeutic indication: Rheumatology) at Santenay(6 months)