Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

NCT02116218 | Withdrawn DMC

• 1 other identifier: TCM-2014-ED
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Pain

Keywords

Traditional Chinese Medicine; acupuncture; complementary alternative medicine; cancer pain; emergency department

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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.

Study Arms (2)

acupuncture

EXPERIMENTAL

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

Procedure: acupuncture

seed

SHAM COMPARATOR

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

Interventions

acupuncture PROCEDURE

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.

acupuncture

Vaccaria seed PROCEDURE

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

seed

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian hospital

Changhua, 500, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 23341529 BACKGROUND

• 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.

  PMID: 19009311 BACKGROUND

• 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.

  PMID: 17355955 BACKGROUND

• 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.

  PMID: 16761128 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain; Emergencies

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lun-Chien Lo

  Changhua Christian Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 16, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

TW (1)