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临床试验/jRCTs032240711
jRCTs032240711招募中不适用

A Study of the Efficacy of Peripheral Magnetic Stimulation in Patients with Chronic Low Back Pain -Randomized controlled trial- (rPMS on CLBP patients)

未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
主要终点
Subjective pain intensity of low back pain

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
60age 0month 0week old over 至 85age 0month 0week old under(—)
性别
All

入选标准

  • Patients with chronic low back pain
  • Subjects who meet the following selection criteria
  • Adults between 60 and 85 years old
  • More than 3 months have passed since the onset of low back pain
  • They are in stable general condition (stable vital signs)
  • Want to receive exercise therapy for low back pain
  • Have given a full explanation of the study and have given written consent of their own free will
  • Able to visit the hospital according to the research schedule

排除标准

  • Persons who meet any of the following criteria
  • Have a cardiac pacemaker, cardiac prosthetic valve, or indwelling cardiac catheter
  • Have NYHA II degree or higher heart failure
  • Have apparent intracranial hypertension
  • Have a medical pump
  • Dependent on intravascular or extracorporeal life support devices
  • May have metal fragments or ferromagnetic materials in the body
  • Have a cochlear implant
  • Have a history of syncope
  • Have a history or family history of epilepsy or seizures
  • Have unhealed burns or skin lesions in the lumbar region
  • Have a tumor, infection, fracture, or other low back pain that requires immediate attention
  • There are conditions such as spinal canal stenosis and lumbar disc herniation that are indications for surgery
  • Severe neuromuscular disease
  • Severe dementia, severe psychiatric illness
  • Other conditions deemed inappropriate by the physician

结局指标

主要结局

Subjective pain intensity of low back pain

时间窗: T0: before intervention, T1: after intervention

The change in the Visual analogue scale (VAS) before and after intervention (T0/T1)

次要结局

  • Full body stereoradiography(T0, T2)
  • Lumbar spine MRI (lumbar muscle mass)(T0, T2)
  • Subjective pain intensity of low back pain(T0, T1, T2)
  • Perception and pain quantitative analysis (Pain VisionTM)(T0, T1, T2)
  • Center of gravity sway and center of gravity range of motion in standing position(T0, T1, T2)
  • Body weight and body composition (body composition analyzer)(T0, T1, T2)
  • Roland-Morris Disability Questionnaire (RMDQ)(T0, T1, T2)
  • Tampa Scale for Kinesiophobia-11 (TSK-11)(T0, T1, T2)
  • Central sensitization scale: Short form Central Sensitization Inventory Japanese version(T0, T1, T2)

研究者

发起方
未提供

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