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临床试验/NCT06982573
NCT06982573招募中不适用

The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients With End-Stage Renal Disease (ESRD)

Bundang CHA Hospital2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年8月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
Visual Analogue Sclae (VAS)

研究概览

简要总结

To determine the effectiveness of magnetic stimulation application on alleviating back pain and maintaining muscle mass in patients with end-stage renal disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Adults aged 19 years or older
  • Patients diagnosed with end-stage renal failure and receiving dialysis treatment more than three times a week
  • Back pain intensity of 4 points or higher on the visual analogue scale (VAS)
  • Those with cognitive function that can clearly indicate NRS with a score of 23 points or higher, the criterion for determining cognitive impairment on the Mini Mental State Examination (MMSE) [14]
  • Those who voluntarily decided to participate in this clinical trial after receiving a detailed explanation and fully understanding it and gave written consent to comply with the precautions

排除标准

  • If the pain is due to trauma
  • If it is difficult to participate in the study due to serious mental illness (e.g. schizophrenia, bipolar disorder, etc.) or psychological instability.
  • Patients with severe neurological illness (e.g. stroke, severe dementia, etc.).
  • Those with poor general condition due to unstable cardiovascular, digestive, respiratory, or endocrine systems, or severe internal medical illness such as systemic infection
  • Patients participating in other therapeutic clinical trials or those who have participated in other therapeutic clinical trials within the past 30 days (observational studies are not relevant)
  • If there are contraindications to magnetic stimulation
  • Patients with implanted medical devices (e.g. pacemakers)
  • Metal objects are inserted into the skull
  • A wound on the skin at the attachment site
  • History of epilepsy
  • Cervical pain or musculoskeletal disease
  • Pregnant and lactating women

结局指标

主要结局

Visual Analogue Sclae (VAS)

时间窗: 7 days before intervention/1 day after intervention/1 month after intervention

An assessment in which the subject quantifies the level of pain numerically from 0 to 10. The higher the number, the more intense the pain.

次要结局

  • Short Physical Performance Battery (SPPB)(7 days before intervention/1 day after intervention/1 month after intervention)
  • The World Health Organization (WHOQOL-BREF)(7 days before intervention/1 day after intervention/1 month after intervention)
  • 3D Motion Capture(7 days before intervention/1 day after intervention/1 month after intervention)
  • Dual Energy X-ray Absorptionmetry (DEXA)(7 days before intervention/1 day after intervention/1 month after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MinYoung Kim, MD, PhD

Principle investigator

Bundang CHA Hospital

研究点 (2)

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