Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02116218
• Other study ID #: TCM-2014-ED
• Status: Withdrawn
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2020
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Emergencies
• Neoplasms
• Pain

Intervention

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.
• Vaccaria seed
We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.

Locations

Country	Name	City	State
Taiwan	Changhua Christian hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Azevedo São Leão 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. Epub 2006 Jun 8. Review. — View 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. Review. — View 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. Review. — View 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. Epub 2007 Mar 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes after intervention
Primary	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	15 minutes after intervention
Secondary	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.	15 minutes after intervention
Secondary	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.	7 days after intervention
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 2 hours.