Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Measuring the effect of spa treatment on functional severity of arthrosis
研究概览
简要总结
Assessment of the effect of spa treatment on the functional severity of arthrosis.
Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.
Primary outcome measure:
-
Measuring the effect of spa treatment on functional severity of arthrosis
-
Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)
Secondary outcome measures
-
Quantitative evaluation of pain
-
Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after
-
Quantitative evaluation of WOMAC
-
Comparison of mean WOMAC between enrollment and 6 months after
-
Impact of spa treatment on the patient's metabolism
-
Height and Weight (BMI calculation)
-
Blood pressure
-
Heart rate
-
Quality of life
-
36-Item Short Form (SF36) at enrollment, 3 months and 6 months
-
EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months
-
Opinion of doctor and patient
-
Semi-quantitative scale collected at enrollment, 3 months and 6 months
-
Treatment follow-up
-
Self-evaluation of pain
-
Self-evaluation of pain with VAS pain scale every 6 week
详细描述
Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena.
Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients.
A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease.
Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain.
Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis
- •Rheumatic indication for spa treatment
- •Diminution of mobility
- •Affiliation to the French social security system or equivalent
- •Available for a 6-months follow-up and an 18-days spa treatment
排除标准
- •Pregnancy, parturient or breast feeding
- •Psychiatric illness or social situation that would preclude study compliance
- •Contraindication to spa treatment
- •Predictable intolerance to thermal treatment
研究组 & 干预措施
Spa Treatment
Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.
干预措施: Spa Treatment (Other)
结局指标
主要结局
Measuring the effect of spa treatment on functional severity of arthrosis
时间窗: 6 months
Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference)
次要结局
- Quantitative evaluation of pain(at baseline, 3 and 6 months)
- Quantitative evaluation of WOMAC(at baseline, 3 and 6 months)
- Patient's BMI(at baseline, 3 and 6 months)
- Opinion of doctor and patient(at baseline, 3 and 6 months)
- Number of treatments prescribed(at baseline, 3 and 6 months)
- Changes in treatments prescribed(at baseline, 3 and 6 months)
- Treatments duration(at baseline, 3 and 6 months)
- Self-evaluation of pain(at baseline, 1.5, 3, 4.5 and 6 months)
- patient examination(at baseline, 3 and 6 months)
- Quality of life(at baseline, 3 and 6 months)