Neoplasms, Pain
Conditions
Keywords
Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department
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.
Interventions
PROCEDUREacupuncture
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.
PROCEDUREVaccaria seed
We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.
Sponsors
Changhua Christian Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 15 minutes after intervention | 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 | 15 minutes after intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Tongue diagnosis | 15 minutes after intervention | 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 | 7 days after intervention | 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 will be followed for the duration of hospital stay, an expected average of 2 hours. | Participants should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment. |
Countries
Taiwan
Outcome results
None listed