Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

February 13, 2020 updated by: Changhua Christian Hospital

Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupuncture
Experimental group would receive acupuncture at specific acupoints for 15 minutes.
Procedure: acupuncture
Acupuncture in the Hegu (LI4), Shousanli (LI10), Zusanli (ST36), Yanlinquan (GB34), Taichong (LV3) and Ouch point. Needles would be correctly inserted and manually stimulated until the 'De Qi' sensation is elicited. The needles would stay in place for 15 minutes.
Sham Comparator: seed
Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.
Procedure: Vaccaria seed
We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes 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
15 minutes after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue diagnosis
Time Frame: 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.
15 minutes after intervention
Brief Pain Inventory
Time Frame: 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.
7 days after intervention
adverse event
Time Frame: 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.
Participants will be followed for the duration of hospital stay, an expected average of 2 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Investigators

  • Study Chair: Lun-Chien Lo, Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCM-2014-ED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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