The Effects of Immersion in 42℃ Radon, Natrium, Calcium, Bicarbonate Content Thermal-mineral Water on Chronic Low-back Pain. Controlled, Follow-up Study
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
- 1
- 主要终点
- The pain during activity evaluated on Visual Analogue Scale (0-100mm)
研究概览
简要总结
In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The planned participants number is 120. Follow up period is 3 months.
详细描述
In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The balneotherapy takes place in Rudas Spa in Budapest, 15 times in 3 weeks. The intensity of pain in rest and during activity evaluated on Visual Analogue Scale (VAS), the Oswestry Disability Index and the Euroqol-5D is taken at week 0., at week 3. and at week 12. The planned participants number is 120. Follow up period is 3 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •outpatients suffering from non-specific chronic low back pain standing for at least 12 weeks; only slightly reduced mobility (able to admit the treatments or visits on his own or without the help of another person);
- •pain intensity of low back pain during activity at least 35 on Visual Analog Scale (0-100 mm VAS); likely degenerative symptoms
排除标准
- •severe neurological deficit associated with the lower back;
- •suspected vertebral compression of osteoporotic or other aetiology;
- •malignancy;
- •pain due to inflammatory spinal disease;
- •severe spondylolisthesis (grade 2 or above);
- •balneotherapy within 3 months prior the enrollement
- •steroid therapy within 1 month prior the enrollement
- •and general contraindications to balneotherapy: decompensated cardiopulmonary status (unstable hypertension, earlier tromboembolia, serious arteriosclerosis obliterans, serious varicositas, etc), unbalanced endocrinological and metabolic disease, fever condition, infectious disease, extensive inflammation/injury/absence of the skin, other severe interstitial, urogenital, and other diseases, malignancy, urine and stool incontinent, decompensated psychosis and neurosis, unconsciousness, pregnancy, postoperative status, alcoholic influence, and lack of compliance.
研究组 & 干预措施
control group
usual care
balneotherapy group
balneotherapy plus usual care
干预措施: balneotherapy (Other)
结局指标
主要结局
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
时间窗: 48 hours before the measuring time
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
次要结局
- The pain at rest evaluated on Visual Analogue Scale (0-100mm)(48 hours before the measuring time)
- Oswestry disability index(through study completion, an average of 12 weeks)
- patient acceptable symptom state (PASS)(through study completion, an average of 12 weeks)
- EuroQol 5D index and VAS(through study completion, an average of 12 weeks)
研究者
Tamas Gati
Principal Investigator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest