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Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

Primary Purpose

Neoplasms, Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Vaccaria seed
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhua Christian hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

acupuncture

seed

Arm Description

Experimental group would receive acupuncture at specific acupoints for 15 minutes.

Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.

Outcomes

Primary Outcome Measures

Visual Analog Scale
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
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

Tongue diagnosis
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
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 should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment.

Full Information

First Posted
April 10, 2014
Last Updated
February 13, 2020
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02116218
Brief Title
Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine
Official Title
Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was terminated and the PI has left the institution.
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Pain
Keywords
Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
Experimental group would receive acupuncture at specific acupoints for 15 minutes.
Arm Title
seed
Arm Type
Sham Comparator
Arm Description
Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vaccaria seed
Intervention Description
We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
15 minutes after intervention
Title
Heart rate variability
Description
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
Time Frame
15 minutes after intervention
Secondary Outcome Measure Information:
Title
Tongue diagnosis
Description
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.
Time Frame
15 minutes after intervention
Title
Brief Pain Inventory
Description
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.
Time Frame
7 days after intervention
Title
adverse event
Description
Participants should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lun-Chien Lo
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhua Christian hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23341529
Citation
Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.
Results Reference
background
PubMed Identifier
19009311
Citation
Chiu J, Yau T, Epstein RJ. Complications of traditional Chinese/herbal medicines (TCM)--a guide for perplexed oncologists and other cancer caregivers. Support Care Cancer. 2009 Mar;17(3):231-40. doi: 10.1007/s00520-008-0526-x. Epub 2008 Nov 14.
Results Reference
background
PubMed Identifier
17355955
Citation
van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
Results Reference
background
PubMed Identifier
16761128
Citation
Azevedo Sao Leao Ferreira K, Kimura M, Jacobsen Teixeira M. The WHO analgesic ladder for cancer pain control, twenty years of use. How much pain relief does one get from using it? Support Care Cancer. 2006 Nov;14(11):1086-93. doi: 10.1007/s00520-006-0086-x. Epub 2006 Jun 8.
Results Reference
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Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

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