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Efficacy of Electroacupuncture on Acute Abdomen Emergency Care

Primary Purpose

Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring traditional Chinese medicine, electroacupuncture, abdominal pain

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

electroacupuncture

sham electroacupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessed the change of pain
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).
Assessed the change of pain
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

The duration that patient stay at emergency department (ED) .
The investigators will keep track of the direction (conditions) of post-treatment participant, their time duration at Emergency Department Observation sections.
The ratio is that patient goes to emergency department (ED) because of the same chief complain unexpectedly.
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.

Full Information

First Posted
June 13, 2017
Last Updated
February 14, 2019
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03199495
Brief Title
Efficacy of Electroacupuncture on Acute Abdomen Emergency Care
Official Title
Efficacy of Electroacupuncture on Acute Abdomen Emergency Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture
Keywords
traditional Chinese medicine, electroacupuncture, abdominal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
sham electroacupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
acupuncture needle with TENS device
Primary Outcome Measure Information:
Title
Assessed the change of pain
Description
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).
Time Frame
Before intervention/ 15 minutes after intervention/ 3 days after the intervention
Title
Assessed the change of pain
Description
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).
Time Frame
Before intervention/ 15 minutes after intervention/ 3 days after the intervention
Secondary Outcome Measure Information:
Title
The duration that patient stay at emergency department (ED) .
Description
The investigators will keep track of the direction (conditions) of post-treatment participant, their time duration at Emergency Department Observation sections.
Time Frame
The duration is from the post-treatment to after 3 days that the participant may be discharged.
Title
The ratio is that patient goes to emergency department (ED) because of the same chief complain unexpectedly.
Description
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.
Time Frame
The duration is from the post-treatment to after 3 days that the participant may be discharged.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 20-90 years old,who accepted to enter this trial The patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting, abdominal pain, abdominal distension or constipation. ICD-10 is R101-R1012 Exclusion Criteria: Does not meet the above conditions
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua City
State/Province
Changhua County
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32093785
Citation
Chang YY, Chiu CW, Chen CY, Chang CF, Lee TC, Lo LC, Lee CY, Chang K, Chen PW, Hsieh CJ, Chang YJ, Huang SY. Efficacy of electroacupuncture on acute abdomen emergency care: study protocol for a randomized controlled trial. Trials. 2020 Feb 24;21(1):224. doi: 10.1186/s13063-020-4071-3.
Results Reference
derived

Learn more about this trial

Efficacy of Electroacupuncture on Acute Abdomen Emergency Care

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