Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 试验地点
- 2
- 主要终点
- Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
研究概览
简要总结
Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.
The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.
The secondary objectives are:
- To compare the efficacy of the 2 protocols at 3 months.
- To determine the evolution of quality of life and medical care consumption
- To describe postural abnormalities
- To determine predictive factors to a favourable response at 3 and 6 months
详细描述
This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both gender
- •uni or bilateral symptomatic knee OA
- •pain VAS > 3 on a 0-10 scale)
- •fulfilling ACR criteria for knee OA
- •Kellgren and Lawrence stage 2 or over on standard radiograph
- •Non inclusion criteria are:
- •severe comorbidity
- •isolated femoro-patellar knee OA
- •total knee replacement surgery expected during the next year
- •other joint disease
- •a contraindication or intolerance to any aspect of spa treatment (immune deficiency, evolving cardiovascular conditions, cancer, infection),
- •spa treatment within the previous 12 months
- •knee injection within the past month for corticosteroids and within the past 3 months for hyaluronic acids
- •osteoarthritis (SYSADOA) change in the past 3 months
- •massages, physiotherapy or acupuncture in the past month
- •Patients will not be allowed to modify their non-steroidal antiinflammatory drug (NSAID) or their analgesic drug within the past 5 days and in the previous 12 h respectively.
排除标准
- 未提供
结局指标
主要结局
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
时间窗: 6 months
The main outcome endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery.
次要结局
- medical care consumption(3 and 6 months)
- Achievement of the patient acceptable symptom state(3 and 6 months)
- evolution of quality of life scores(3 and 6 months)
- adverse events(3 and 6 months)
- postural abnormalities(3 and 6 months)