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
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