Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Changhua Christian Hospital
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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.)