Multicenter Investigation Weight Bath Traction in Chronic Lumbar Spine Pain: a Controlled, Randomiezd, Single Blind Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.
研究概览
简要总结
It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients. For acute lumbar pain, approx. 10-15% of them are converted into chronic. Conservative treatments are few studies done in the traction therapy. A large number of multicenter trials did not evaluate the effectiveness of underwater traction therapy.
详细描述
Goals are the followings:
- Is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters?
- How much does the quality of life change in an initial state and how much is it in comparison with the control group?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •at least 12 weeks of non-specific lymphatic pain,
- •the pain sensitivity of the paravertebral muscle and the painful movement of the lumbar spine can be observed, which can be characterized by segmental motion, segmental instability or other reasons
- •radiographically confirmed spondylosis, discopathy, and spondylarthrosis within one year.
- •back pain at least 30mm (100mm visualis analogue scale).
- •patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months
- •p- atient consent form signed before the start of test
排除标准
- •The exclusion criteria included previous lumbar spine surgery,
- •progressive neurologic loss,
- •pregnancy,
- •(umbilical, hiatal, inguinal) hernia,
- •malignities,
- •infectious diseases,
- •inflammatory pathologies,
- •severe pulmonary and cardiovascular diseases,
- •uncontrolled- hypertension,
- •mental disorders,
- •incontinence,
- •Acute lower back pain;
- •Organic neurological symptoms associated with the lower back;
- •pain in the background of osteoporosis or other causes of vertebral compression is likely
- •Lack of complience,
- •Pain due to inflammatory spinal disease;
- •spondylolisthesis (which is not greater than 25% of vertebral skeleton compared to adjacent vertebrae)
结局指标
主要结局
prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.
时间窗: at the first visit and After at the 3 and the 12 weeks
Change From Baseline in Pain Scores on the Visual Analog Scale at the 3 and the 12 weeks after the treatment.Pain intensity was measured by using the Visual Analog Scale (0-100 mm). Patients recorded on the VAS scale the level of low back pain at rest as well as during activity.
次要结局
- Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.(at the first visit and After at the 3 and the 12 weeks)
- Secondary objective was to evaluate whether it also leads to the improvement in the movements of the lumbal spine.(at the first visit and After at the 3 and the 12 weeks)
研究者
Tamas Gati
Principal Investigator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest