Efficacy of Electroacupuncture on Acute Abdomen Emergency Care

February 14, 2019 updated by: Lee Tsung Chieh, Changhua Christian Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Changhua County
      • Changhua City, Changhua County, Taiwan, 500
        • Changhua Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Before intervention/ 15 minutes after intervention/ 3 days after the intervention
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).
Before intervention/ 15 minutes after intervention/ 3 days after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
The duration is from the post-treatment to after 3 days that the participant may be discharged.
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.
The duration is from the post-treatment to after 3 days that the participant may be discharged.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChanghuaCH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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