Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Effect of spa treatment on lower limb osteoarthritis
研究概览
简要总结
- Primary outcome measure: measuring the effect of spa treatment in patients suffering from lower limb osteoarthritis or any other lower limb rheumatological condition.
Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS) or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement of at least 9 points (minimal clinically important difference), 6 months after enrollment.
Secondary outcome measures: 2. Measuring the effect of spa treatment in patients with concomitant chronic lower back pain.
Percentage of patients presenting clinical benefits according to the EIFEL score, with a decrease of at least 5 points, 6 months after enrollment. 3. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6 months after spa treatment. 4. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment and 6 months after spa treatment. 5. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment and 6 months after spa treatment. 6. Impact of spa treatment on the patient's metabolism. Height and weight (BMI calculation), blood pressure and heart rate measured at enrollment and throughout the follow-up. 7. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D) questionnaires at enrollment, 3 months and 6 months.
9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and 6 months.
10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the medical visit at enrollment, 3 months and 6 months.
11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more precise time frame of the treatment's effect.
详细描述
Osteoarthritis and rheumatic conditions in general are a major public health issue, notably causing chronic pain disorders.
Spa treatments currently play a central role in the non-medical therapeutic arsenal for patients suffering from these rheumatic diseases.
A French study estimated the direct costs generated by osteoarthritis in France up to 1,6 billion euros in 2002, half of which was due to hospital expenses (800 million euros). Osteoarthritis required 13 millions consults and drug expenses of 570 million euros. Compared to 1993, these expenses increased by 156% due to the raise of the number of patients treated (+54%) and of the cost for each patient (+2,5% per year). This study concerned patients with lower limb osteoarthritis, and a significant portion of these expenses were attributable to the disease.
Chronic lower back pain is also a major health issue for its impact on patients' functional capacities as well as for the economic and social costs it generates. This is a frequent condition, it is estimated that 80% of the population will present lower back pain at some point in their life. Furthermore, epidemiological studies show an increase in the prevalence of lower back pain (3,9% in 1992 to 10,2% in 2006 in the American population).
Different well-conducted studies around the impact of spa treatments have led to the recognition of its beneficial outcome on the treatment of chronic lower back pain.
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 presenting an indication for rheumatological spa treatment
- •Patient with osteoarthritis or other rheumatic disease, located on the lower limbs with or without chronic lower back pain.
- •Functional impairment with reduced mobility
- •Life expectancy > 6 months
- •VAS pain evaluation > 30 mm
- •Available for a 6-months follow-up and an 18-days spa treatment
- •Affiliation to the French social security system or equivalent
- •Patient living within 100 kms of recruitment center
排除标准
- •Patient having already underwent a spa treatment for rheumatic indication 6 months within enrollment
- •Pregnancy, parturient or breast feeding
- •Psychiatric illness or social situation that would preclude study compliance
- •Predictable intolerance to thermal treatment (immunodeficiency, advanced cardiopathy, active cancer, active pulmonary tuberculosis, severe renal failure, cirrhosis, advanced dementia and severe mental conditions)
结局指标
主要结局
Effect of spa treatment on lower limb osteoarthritis
时间窗: At 6 months
Percentage of patients with a WOMAC score improvement of 9 or more points and/or with a decrease in VAS of at least 19,9 mm (minimal clinically important difference)
次要结局
- Doctor / patient opinions(At baseline, 3 and 6 months)
- Quantitative evaluation of pain(At baseline and 6 months)
- Quantitative evaluation of EIFEL(At baseline and 6 months)
- Global quality of life(At baseline, 3 and 6 months)
- Quantitative evaluation of WOMAC(At baseline and 6 months)
- Patient BMI(At baseline, 3 and 6 months)
- Treatment follow-up(At baseline, 3 and 6 months)
- Self evaluation of pain(With investigator at baseline, 3 and 6 months. Auto evaluation at 1.5 months and 4.5 months.)
- Effect of spa treatment on lower back pain(At 6 months)
- Health quality of life(At baseline, 3 and 6 months)