Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with liver cancer. Patients will randomly allocated into PENS group, Tens group and control group.
详细描述
PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on. Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer. TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant is allocated randomly by staff A, and grouping situation is concealed; Technician (stuff B) or chargeing docotor operates PENS or TENS, or administers oral analgesic medication; Related datas are collected according to perdetermined forms by stuff C; Outcomes are assessed by stuff D.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary liver cancer with pain;
- •Haven't underwent neurolytic celiac plexus block in the past 1 month;
- •With anticipatory survival of more than 3 months.
排除标准
- •Metastatic liver cancer;
- •Can not tolerate a flat or side lying or sitting prostrate for 30 min;
- •performance score>3;
- •Who has been recruited in other clinical trial for pain relieving;
- •Who underwent radiotherapy or local radioactive seeds implantation for pain relieving in the past month;
- •Imaging diagnosed with encephalic tumor or metastasis;
- •Who with cardiac pacemaker or metal stand;
研究组 & 干预措施
percutaneous stimulation
PENS in 2/100 hertz (HZ), 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
干预措施: PENS (Device)
transcutaneous stimulation
TENS in 2/100 HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
干预措施: TENS (Device)
Control
Conventional analgesic medication is offered.
结局指标
主要结局
pain score
时间窗: day0 to day6
pain score assessed via visual analogue scale (VAS)
次要结局
- quantity of analgesic medication(day0 to Day6)
- times of breakthrough pain (BTP)(day0 to day6)