Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help.
Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment.
This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 75 years, either gender.
- •Visit emergency department
- •Chief complaint is pain.
- •Diagnosed by oncologist with International Classification of Diseases 9th revision (ICD-9) code between 140.0 to 239.9.
排除标准
- •Serious comorbid conditions (for example, life-threatening condition).
- •Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.
- •Pregnancy status.
研究组 & 干预措施
acupuncture
Experimental group would receive acupuncture at specific acupoints for 15 minutes.
干预措施: acupuncture (Procedure)
seed
Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.
干预措施: Vaccaria seed (Procedure)
结局指标
主要结局
Visual Analog Scale
时间窗: 15 minutes after intervention
The Visual Analog Scale (VAS) has proven its usefulness and its clinical validity for the evaluation of pain. VAS would be measured and compared before and after intervention.
Heart rate variability
时间窗: 15 minutes after intervention
Autonomic nervous dysfunction plays a role as a consequence of pain. Recording the heart rate variability (HRV) in an easy non-invasive methods to investigate autonomic balance. HRV would be measured and compared before and after intervention
次要结局
- Tongue diagnosis(15 minutes after intervention)
- Brief Pain Inventory(7 days after intervention)
- adverse event(Participants will be followed for the duration of hospital stay, an expected average of 2 hours.)