Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms, Pain

Intervention / Treatment
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* Procedure: acupuncture
* Procedure: Vaccaria seed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>Experimental group would receive acupuncture at specific acupoints for 15 minutes. | Procedure: acupuncture<br>* 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.<br>|
| Sham Comparator: seed<br>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<br>* We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department