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Efficacy of Electroacupuncture on Acute Abdomen Emergency Care

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ClinicalTrials.gov Identifier: NCT03199495
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Tsung Chieh, Changhua Christian Hospital

Brief Summary:

Contrast to conventional Western medicine, traditional Chinese medicine is the most common used therapy of complementary and alternative medicine. Taiwan inherits traditional Chinese culture, and the people popularly accept traditional Chinese medicine for general diseases. However, most patients with acute or critical illness are used to admit to emergency department for medical services, and then transfer to the department of related specialist for further treatment. During the course of staying at emergent observation room, some diseases do not meet the criteria of admission and keep for evaluation. The longer of staying at emergent observation room the more waste medical resources.

The Chinese medicine department of Changhua Christian hospital has treated patients, who consulted us at their own dispense, with subjective discomfort but remained at the emergent observation room. Detailed contents of this study include the Chinese and Western medicine, pharmaceutical, nursing cooperation mode, monitoring clinical effect of treating of the patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting, abdominal pain, abdominal distension or constipation.And the patients were assigned to the control and treatment group. Then we give the treatment group with the electroacupuncture treatment,and the control groupe with the Chinese medicine seeds and the transcutaneous nerve stimulation (no power).The patients were diagnosed with objective analysis of tongue diagnosis, pulse diagnosis, heart rate variability, and questionnaire of pain. Hope that we can assess the efficacy of both two different treatment,and also assess the cost of medical care, and try to complete the syndromes statistical analysis of traditional Chinese medicine for abdominal pain, building the relevance of Chinese medicine physical assessment teaching and clinical efficacy.

The most important of this clinical teaching is that, this is a good opportunity for Chinese medicine and Western medicine to cooperate with each other at the emergency department to confirm the efficacy of traditional Chinese medicine, not only in the field of chronic or geriatric diseases, but also in the field of emergency with the evidence base. This factually achieves communication and integration of Chinese and Western medicine, and benefits the public.


Condition or disease Intervention/treatment Phase
Acupuncture Other: electroacupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Electroacupuncture on Acute Abdomen Emergency Care
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 16, 2018
Estimated Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: electroacupuncture
Participants were randomized divided into experimental and control groups .Acupuncture included Hegu (LI 4), Neiguan (PC6), Zusali (ST 36), Shanjuxu (ST37), Xiajuxu (ST39), Taichong (LR3) and Taibai(SP3) on both hands and legs. Acupuncture included Hegu (LI 4) and Neiguan (PC6), Zusali (ST 36) and Taichong (LR3) with electrical stimulation were conducted. The frequency of electrical stimulation was 2 Hz and the intensities of the stimulation was below 9.8 mA for 15 minutes.After 15 minutes treatment, acupuncture were removed and after 15 minutes the investigators stated to evaluate.
Other: electroacupuncture
acupuncture needle with TENS device

Sham Comparator: sham electroacupuncture
Participants were randomized divided into experimental and control groups. The Vaccaria Seeds (scientific name:Vaccaria segetalis) will be applied in control group. Vaccaria Seed is a spherical, smooth and hard seed, which is commonly used on ear acupuncture point. In control group, Vaccaria Seeds will be secured on the acupuncture point the same as experimental group, and coverd by transcutaneous electrical nerve stimulation (TENS), which is actually not turned on. The intervention will last for 15 minutes.After 15 minutes treatment, acupuncture were removed and after 15 minutes the investigators stated to evaluate.
Other: electroacupuncture
acupuncture needle with TENS device




Primary Outcome Measures :
  1. Assessed the change of pain [ Time Frame: Before intervention/ 15 minutes after intervention/ 3 days after the intervention ]
    The primary outcome evaluation was the visual analog scale (VAS) for pain. Visual analog scale is graded from 0 (no pain) to 10 (worst possible pain) and has proven its usefulness and clinical validity for the evaluation of pain. Patients were evaluated at two timepoints in this study: intervention (VAS-1), after intervention (VAS-2), 3 days after the intervention (VAS-3).

  2. Assessed the change of pain [ Time Frame: Before intervention/ 15 minutes after intervention/ 3 days after the intervention ]
    The primary outcome evaluation was the the brief pain inventory (BPI) for pain. Brief pain inventory is used to assess the severity of pain and the impact of pain on daily functions. Patients were evaluated at two timepoints in this study: intervention (BPI-1), after intervention (BPI-2), 3 days after the intervention (BPI-3).


Secondary Outcome Measures :
  1. The duration that patient stay at emergency department (ED) . [ Time Frame: The duration is from the post-treatment to after 3 days that the participant may be discharged. ]
    The investigators will keep track of the direction (conditions) of post-treatment participant, their time duration at Emergency Department Observation sections.

  2. The ratio is that patient goes to emergency department (ED) because of the same chief complain unexpectedly. [ Time Frame: The duration is from the post-treatment to after 3 days that the participant may be discharged. ]
    The investigators will keep track of the rate of post-treatment participant of return to the emergency department (ED) for the same chief complain within 3 days.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 20-90 years old,who accepted to enter this trial
  2. The patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting, abdominal pain, abdominal distension or constipation.
  3. ICD-10 is R101-R1012

Exclusion Criteria:

Does not meet the above conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199495


Contacts
Contact: Tsung Chieh Lee +886-04-7238595 ext 4229 sara66815@gmail.com

Locations
Taiwan
Changhua Christian Hospital Recruiting
Changhua City, Changhua County, Taiwan, 500
Contact: Tsung Chieh Lee         
Sponsors and Collaborators
Changhua Christian Hospital

Responsible Party: Lee Tsung Chieh, Vice director of Chinese Medicine, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03199495     History of Changes
Other Study ID Numbers: ChanghuaCH
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lee Tsung Chieh, Changhua Christian Hospital:
traditional Chinese medicine
electroacupuncture
abdominal pain

Additional relevant MeSH terms:
Emergencies
Abdomen, Acute
Disease Attributes
Pathologic Processes
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive