AcupunctureNCT03199495
Efficacy of Electroacupuncture on Acute Abdomen Emergency Care
A study testing electroacupuncture in people with Acupuncture, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acupuncture
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2017to 16 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet the above conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acupuncture
- Being tested
- electroacupuncture
- Keywords
- traditional Chinese medicine, electroacupuncture, abdominal pain
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
acupuncture needle with TENS device
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | 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. Receives: Other: electroacupuncture |
| sham electroacupuncture | Sham comparator | 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. Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before intervention/ 15 minutes after intervention/ 3 days after the intervention
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).
Measured: Before intervention/ 15 minutes after intervention/ 3 days after the intervention
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: The duration is from the post-treatment to after 3 days that the participant may be discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start17 Apr 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Tsung Chieh, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199495
- Sponsor's protocol ID
- ChanghuaCH
- Status last verified
- Feb 2019
- First submitted
- 13 Jun 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32093785
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electroacupuncture on Acute Abdomen Emergency Care
- ClinicalTrials.gov ID
- NCT03199495
- Acronym / sponsor ID
- ChanghuaCH
- Conditions
- Acupuncture
- Keywords
- traditional Chinese medicine, electroacupuncture, abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Other: electroacupunctureParticipants 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. |
| sham electroacupuncture | Sham comparator | Other: electroacupunctureParticipants 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet the above conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureacupuncture needle with TENS device | Other | electroacupuncture, sham electroacupuncture |
Primary outcome
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).
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).
2 secondary outcomes
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 32093785Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Acupuncture, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessed the change of pain (time frame: Before intervention/ 15 minutes after intervention/ 3 days after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.