Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Achievement of minimal clinically important improvement (MCII) at 6 months
研究概览
简要总结
Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI.
In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.
详细描述
Methods: randomised prospective clinical trial of patients with knee osteoarthritis.
The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit.
Follow-up was at 3 and 6 months, by a visit to the examination.
The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage
- •Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year
- •Patient affiliated with a social security system
排除标准
- •Realization of a water cure in the last 6 months
- •Infiltration of the knee of less than 3 months
- •Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
- •Person major placed under guardianship or trusteeship,
- •Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
- •Patient already included in an interventional clinical protocol,
- •Pregnant women
- •Contraindication in the water cure:
- •Severe change of the general state or debilitating afflictions
- •Acute affections and pushed acute(sharp) of the chronic affections
- •Grave cardiac insufficiency, unstable arterial high blood pressure
- •Severe renal or hepatic insufficiency
- •Not healed cutaneous hurts
- •Contagious or evolutionary diseases
- •Evolutionary Cancers
- •Current immunomodulator or immunosupressor Treatment, waves of inflammation.
研究组 & 干预措施
Thermal care
Spa Treatment realised daily 6 days a week during 18 days
干预措施: Spa Treatment (Other)
Standard Care
Usual care
结局指标
主要结局
Achievement of minimal clinically important improvement (MCII) at 6 months
时间窗: 30 months
The main 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 osteoart
次要结局
- Achievement of minimal clinically important improvement (MCII) at 3 months(30 months)