Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

Not Applicable

Withdrawn

• Conditions: Neoplasms; Pain
• Interventions: Procedure: Vaccaria seed; Procedure: acupuncture

• Registration Number: NCT02116218
• Lead Sponsor: Changhua Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
seed	Vaccaria seed	Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.
acupuncture	acupuncture	Experimental group would receive acupuncture at specific acupoints for 15 minutes.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	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	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 Outcome Measures

Name	Time	Method
Tongue diagnosis	15 minutes after intervention	Tongue diagnosis plays an important role in TCM. In clinical practice Practitioners observed tongue characteristics, such as the color and shape, and the amount of saliva before deducing the primary ailment of a patient.; We would take photos of tongue before and after intervention to compare the clinical changes.
Brief Pain Inventory	7 days after intervention	Brief Pain Inventory (BPI) was made by Pain Research Group in order to measure the pain score of cancer patients.; We would do the questionnaire before and 7 days after intervention to investigate if there's a long-term effect.
adverse event	Participants will be followed for the duration of hospital stay, an expected average of 2 hours.	Participants should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment.

Trial Locations

Locations (1)

Changhua Christian hospital; 🇨🇳 Changhua, Taiwan