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)
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
- 否
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
MinYoung Kim, MD, PhD
Principle investigator
Bundang CHA Hospital
研究点 (2)
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