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The study was terminated and the PI has left the institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | Experimental group would receive acupuncture at specific acupoints for 15 minutes. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lun-Chien Lo | Changhua Christian Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian hospital | Changhua | 500 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23341529 | Background | 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. | |
| 19009311 | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| D000072716 | Cancer Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Vaccaria seed | Procedure | We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group. |
|
| 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. |
| 17355955 | 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. |
| 16761128 | 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. |
| D010335 | Pathologic Processes |