Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain: An Open-labeled, Single-arm, Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
研究概览
简要总结
The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.
详细描述
The purpose of this study was to evaluate the effectiveness of acupuncture treatment in the patients with the following neuropathic pain related syndrome.
- Postherpetic neuralgia
- Failed back surgery syndrome
- Diabetic neuropathy
- other peripheral neuropathy
Patients with refractory neuropathic pain who do not respond to conservative treatment for more than 3 months should be included. Acupuncture treatment is maintained for 2 months in oriental medicine hospital. The effect is evaluated through the numeric rating score and the validated questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who can adequately write a reportable questionnaire
- •Patients who have been diagnosed with one of the following neuropathic pain disease (postherpetic neuralgia, failed back surgery syndrome, diabetic neuropathy, other peripheral neuropathy)
- •Patients who failed conservative treatment at Seoul National University Hospital for more than 3 months.
- •Patients with NRS 5 points or more
- •Patients with painDETECT score 19 points or more
排除标准
- •Patients with major mental illness
- •Patients with unstable medical conditions
- •Patients who received acupuncture treatment at the site within the past month
- •Patients with bleeding tendency
- •Patients taking immunosuppressive drugs
结局指标
主要结局
Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
时间窗: At 8-week follow-up visit
The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%).
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks
时间窗: At 4-week follow-up visit
The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%).
次要结局
- Change from the score of the short-form McGill Pain Questionnaire at 8 weeks(At 8-week follow-up visit)
- Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks(At 8-week follow-up visit)
- 5-pointed patient satisfaction scale(At 8-week follow-up visit)
- Patients' Global Impression of Change (PGIC) scale(At 8-week follow-up visit)
研究者
Jeeyoun Moon
Associate professor
Seoul National University