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临床试验/NCT04485182
NCT04485182终止不适用

Underwater Jet Massage Therapy for Chronic Low Back Pain

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
60
试验地点
1
主要终点
Tangentor

研究概览

简要总结

Underwater massage is the more modern variety of massages otherwise known as tangentor, where the temperature of the water of the treatment tub and the mechanical effect of the water jet is utilised. It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients.

Our goals are the followings:

  1. Is the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters?
  2. How much does the quality of life change in an initial state and how much is it in comparison with the control group?

详细描述

Informed consent was obtained from all participants. We use two groups to investigate the effects of the tangentor on the low back pain.

The patients presenting at the rheumatology inpatient clinics were enrolled without into the treatment and control groups.

Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics

In the controll group the Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics

Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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).
  • patient consent form signed before the start of test

排除标准

  • patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months
  • The exclusion criteria included:
  • previous lumbar spine surgery,
  • progressive neurologic loss,
  • pregnancy,
  • umbilical- , 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; malignity in the background;
  • 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

Tangentor

时间窗: 2 years

Investigate the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters on a Visual Analogue Scale (VAS)

次要结局

  • Tangentor(2 years)

研究者

发起方
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamas Gati

1027 Budapest Árpád fejedelem út 7.

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

研究点 (1)

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