The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pain before intervention to be assessed with Numeric Rating Scale
研究概览
简要总结
Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities.
Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN.
Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores [PCSs and MCSs]), at 1-week post-treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neuropathic pain (stocking glove distribution) of a numeric rating scale (NRS) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities
- •pain duration of ≥3 months
- •age between 21 and 80 years
排除标准
- •presence of contraindications for TMS, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker.
结局指标
主要结局
Pain before intervention to be assessed with Numeric Rating Scale
时间窗: The NRS score will be assessed the day before starting the stimulation sessions (pre-treatment).
We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Pain after intervention to be assessed with Numeric Rating Scale
时间窗: The NRS score will be assessed 1 week after the completion of the sessions.
We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Quality of life before intervention to be assessed with Short Form 36-Item Health Survey
时间窗: The SF-36 PCS and SF-36 MCS will be measured the day before starting the stimulation sessions.
We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Quality of life after intervention to be assessed with Short Form 36-Item Health Survey
时间窗: The SF-36 PCS and SF-36 MCS will be measured 1 week after the completion of the sessions.
We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
次要结局
未报告次要终点
研究者
Min Cheol Chang
Associate Professor
Yeungnam University College of Medicine