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临床试验/NCT05622630
NCT05622630已完成不适用

Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy

Paracelsus Harz Clinic Bad Suderode.2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Vibration sensation test

研究概览

简要总结

Sensorimotor diabetic polyneuropathy is a common and serious complication of longstanding diabetes mellitus. The therapeutic options are limited (pain therapy, antidepressants, physical measures using direct current such as two- / four-cell baths). In the present study, for the first time, after positive data from a pilot study, it is to be checked whether the effectiveness of an existing therapy can be extended by treatment with heated granulate stones in the rehabilitation setting.

详细描述

The central aspect of this study is the proof of the effectiveness of the therapeutic treatment of diabetic polyneuropathy with heated granulate stones.

Subsequent information from the study doctor and the patient's written consent will remove the sociodemographic relationships from the standards of the Paracelsus Harz Clinic Bad Suderode. Behavioral behavior and sporting behavior among those affected, as well as the course of the disease, are treated using a questionnaire. Furthermore, medical parameters (echocardiographic parameters, penalties, weight, BMI, waist-hip ratio, blood glucose, HbA1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, etc.) are determined.

A randomization list was created for randomization, with the randomization algorithm assigning patient IDs to the two treatment groups. Randomization takes place using previously sealed, opaque and consecutively numbered envelopes.

After randomization at time T0 (before the first treatment) and T1 (after the last treatment), the patients receive a questionnaire (see appendix) in which they should state the symptoms, how long they have existed and the assessment of the intensity. The assessment of the intensity is based on a spectrum from 1 = minor complaints to 6 = severe complaints.

Quality of life is measured using the SF-12 questionnaire, and anxiety and depression using the HADS questionnaire are also measured at time points T0 and T1.

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
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

入选标准

  • Age> 18 years of age
  • diabetic polyneuropathy
  • Inpatient stay in the Paracelsus Harz Clinic Bad Suderode

排除标准

  • Lack of consent
  • Infections on the extremities to be bathed
  • Skin damage on the extremities to be bathed
  • Pacemaker or ICD implantation
  • Metal (e.g. osteosynthesis materials) in the parts of the body to be bathed

结局指标

主要结局

Vibration sensation test

时间窗: day 20

Vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the wrist, metatarsophalangeal joint of the big toe, inner ankle and the tibial

次要结局

未报告次要终点

研究者

发起方
Paracelsus Harz Clinic Bad Suderode.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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