Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 试验地点
- 3
- 主要终点
- the more small change clinically relevant of the WOMAC indice and/or of pain.
研究概览
简要总结
The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.
详细描述
Gonarthrosis is a frequent pathology and the prevalence increase with age (prevalence: 6,1% in an adult population more than 30 years old and 40% after 75 years). It has a large impact on the quotidian life of the patients and it cause important costs for social protection. Relative to the treatment, numerous recommendations have been proposed (EULAR, ACR specifically). But no one of them recommends thermal treatment even if it is largely used in Europe and especially in France for the treatment of this pathology. Several prospective controlled randomized studies have evaluated the effect of the thermal treatments in rheumatology and some of them are relative, in part, to Gonarthrosis. So, we conduct a phase III randomized, controlled, single blind study evaluating the therapeutic effect at 6 month of a thermal cure on gonarthrosis.
In a situation of physical treatment, it's impossible to use a placebo as control: blind can't be respected. Whatever the methodology employed, non blind of the patient create a bias. So, we hope that the Zelen method for randomization will reduce the bias due to the dissatisfaction of the patients in the control group.
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
- •ACR criteria: knee pain and one of the tree following conditions: Age > 50 years, Morning stiffness< 30 minutes and articular crackling.
- •osteophytes visible on knee radiography.
- •knee radiography less than 3 years old: face, schuss, axial of kneecap cliché.
- •Actual gonarthrosis intensity on Visual Analogic Scale > or = 30mm.
排除标准
- •arthrosis limited to the femoro-patellar compartments.
- •severe depressive syndrome, psychosis.
- •Thermal cure less than 6 month before.
- •Contra-indication or predictable inability to tolerate thermal cure.
- •Profession lied to hydrotherapy.
- •previous knee treatments:
- •massage, physiotherapy and acupuncture since less than 1 month;
- •infiltration since less than 3 months;
- •NSAI since less than 5 days;
- •analgesic since less than 12 hours;
- •modification in the medicinal anti-arthrosis treatment since less than 3 months.
研究组 & 干预措施
1
group with 18 days thermal cure
干预措施: thermal cure (Drug)
2
group with no thermal cure but only access 3 days to watering place 6 months after inclusion
干预措施: 3 days access to watering place at 6 months (Drug)
结局指标
主要结局
the more small change clinically relevant of the WOMAC indice and/or of pain.
时间窗: at 6 months
次要结局
- WOMAC indice and pain (EVA)(at inclusion and 1, 3, 6 and 9 months)
- The clinically acceptable symptom for the patient(at 6 months)
- Clinical evaluation(at inclusion and 1, 3 and 6 months)
- Opinion of the patient and the physician(at 1, 3 and 6 months)
- Quality of life: questionnaire SF-36(inclusion and 1, 3, 6 and 9 months)
- Treatments: medicinal consumption, physical treatments, hospitalization, consumption of cares getting back by the Medicaid of Savoie (CPAM, only for the study centre of Aix-les-Bains)(inclusion and 1,3,6 months)