Paralytic IleusNCT03041675
Effects of Laser Acupuncture Therapy on Paralytic Ileus
A study testing Laser Acupuncture group in people with Paralytic Ileus, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less and less effective over time. Some study revealed that Moxibustion and Acupuncture are effective in Paralytic ileus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Paralytic Ileus
- What is being tested?
- Laser Acupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Feb 2017to 31 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Already sign test consent permit.
- More than 20-year-old.
- Doctors diagnosis as Paralysis ileus, and KUB report was improved as Paralysis ileus by Radiologists.
Who cannot join
- Pregnant.
- Patients taking immunosuppressive or morphine analgesics.
- Skin infections.
- Without test consent permit.
- mechanical ileus, mechanical obstruction.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Ching-Liang Hsieh, professor, +886-4-22053366 ext. 3500, clhsieh@mail.cmuh.org.tw
SZU YU LIU, Doctor, +886-975829732, m90641@gmail.com
About this study
Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less and less effective over time. Some study revealed that Moxibustion and Acupuncture are effective in Paralytic ileus. Investigators try to find other treatment except of medicine. Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of Laser Acupuncture on Paralytic ileus.
Read the detailed description
This study's sample consisted of 94 adult participants who had Paralytic ileus. Patients experiencing skin disease or wounds, pregnancy, less than 20 years old, and who take Immunosuppressants drugs or Morphine, Mechanical obstruction were excluded. These 94 patients were randomly divided into two groups: a Laser Acupuncture group and a control group. At the beginning of study, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, frequent of enema, average amount of stool per day. 47 patients received Laser Acupuncture therapy three times a week in acupoints RN6, RN4, and RN12. The whole duration of treatment is 8 weeks. The control group patients receive pseudo laser acupuncture. In the end of 4th and 8th week, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, observe the daily record and then calculate frequent of enema and average amount of stool per day. After the end of treatment, the investigators keep follow up for 4 weeks. The outcome parameters include:
- KUB,
- the average amount of stool every day,
- frequency of bowel sound,
- frequency of enema, (Indication of enema: the amount of stool less than 200g within 3 days),
- the change of serum Gastrin, Motilin, and Pancreatic polypeptide.
- Conditions
- Paralytic Ileus
- Being tested
- Laser Acupuncture group, Sham Laser Acupuncture group
- Keywords
- Lacer Acupuncture, Paralytic ileus
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Acupuncture groupDevice
47 participants receive 10 seconds of Laser Acupuncture(808nM/300mW) on acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks.
Sham Laser Acupuncture groupDevice
The investigators apply the Laser Acupuncture pen (without pressing the Laser button) on other 47 participants' acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture group | Experimental | 47 participants receive 10 seconds of Laser Acupuncture(808nM/300mW) on acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. Receives: Device: Laser Acupuncture group |
| Sham Laser Acupuncture group | Sham comparator | The investigators apply the Laser Acupuncture pen (without pressing the laser button) on other 47 participants' acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. Receives: Device: Sham Laser Acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changing of diameter of colon (KUB)
Definition of Ileus: Diameter of colon: >6cm. Check KUB on the 4th, 8th, 12th week. Calculate the biggest diameter of colon. Is diameter of colon decreasing in Laser Acupuncture group?
Measured: the 4th, 8th, 12th week
Secondary outcomes (1)
the average amount of stool per day(g/Day)
Is the average amount of stool per day elevating in laser group?
Measured: the 4th, 8th, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start13 Feb 2017 (estimated)
- Primary completion30 Jun 2017 (estimated)
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paralytic IleusStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041675
- Sponsor's protocol ID
- CMUH105-REC1-133
- Status last verified
- Feb 2017
- First submitted
- 23 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang JS, Lee SB, Park SY. The effect of SSP therapy on elderly nursing home residents' chronic constipation. J Phys Ther Sci. 2015 Dec;27(12):3887-9. doi: 10.1589/jpts.27.3887. Epub 2015 Dec 28.
PubMed 26834374Moriya R, Fujikawa T, Ito J, Shirakura T, Hirose H, Suzuki J, Fukuroda T, Macneil DJ, Kanatani A. Pancreatic polypeptide enhances colonic muscle contraction and fecal output through neuropeptide Y Y4 receptor in mice. Eur J Pharmacol. 2010 Feb 10;627(1-3):258-64. doi: 10.1016/j.ejphar.2009.09.057. Epub 2009 Oct 8.
PubMed 19818748
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laser Acupuncture Therapy on Paralytic Ileus
- ClinicalTrials.gov ID
- NCT03041675
- Acronym / sponsor ID
- CMUH105-REC1-133
- Conditions
- Paralytic Ileus
- Keywords
- Lacer Acupuncture, Paralytic ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2017 (estimated)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- 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.
Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less and less effective over time. Some study revealed that Moxibustion and Acupuncture are effective in Paralytic ileus. Investigators try to find other treatment except of medicine. Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of Laser Acupuncture on Paralytic ileus.
Detailed description
This study's sample consisted of 94 adult participants who had Paralytic ileus. Patients experiencing skin disease or wounds, pregnancy, less than 20 years old, and who take Immunosuppressants drugs or Morphine, Mechanical obstruction were excluded. These 94 patients were randomly divided into two groups: a Laser Acupuncture group and a control group. At the beginning of study, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, frequent of enema, average amount of stool per day. 47 patients received Laser Acupuncture therapy three times a week in acupoints RN6, RN4, and RN12. The whole duration of treatment is 8 weeks. The control group patients receive pseudo laser acupuncture. In the end of 4th and 8th week, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, observe the daily record and then calculate frequent of enema and average amount of stool per day. After the end of treatment, the investigators keep follow up for 4 weeks. The outcome parameters include:
- KUB,
- the average amount of stool every day,
- frequency of bowel sound,
- frequency of enema, (Indication of enema: the amount of stool less than 200g within 3 days),
- the change of serum Gastrin, Motilin, and Pancreatic polypeptide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture group | Experimental | Device: Laser Acupuncture group47 participants receive 10 seconds of Laser Acupuncture(808nM/300mW) on acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. |
| Sham Laser Acupuncture group | Sham comparator | Device: Sham Laser Acupuncture groupThe investigators apply the Laser Acupuncture pen (without pressing the laser button) on other 47 participants' acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Already sign test consent permit.
- More than 20-year-old.
- Doctors diagnosis as Paralysis ileus, and KUB report was improved as Paralysis ileus by Radiologists.
Key exclusion criteria (5 listed)
- Pregnant.
- Patients taking immunosuppressive or morphine analgesics.
- Skin infections.
- Without test consent permit.
- mechanical ileus, mechanical obstruction.
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 |
|---|---|---|
| Laser Acupuncture group47 participants receive 10 seconds of Laser Acupuncture(808nM/300mW) on acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. | Device | Laser Acupuncture group |
| Sham Laser Acupuncture groupThe investigators apply the Laser Acupuncture pen (without pressing the Laser button) on other 47 participants' acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks. | Device | Sham Laser Acupuncture group |
Primary outcome
the changing of diameter of colon (KUB)
Time frame: the 4th, 8th, 12th week
Definition of Ileus: Diameter of colon: >6cm. Check KUB on the 4th, 8th, 12th week. Calculate the biggest diameter of colon. Is diameter of colon decreasing in Laser Acupuncture group?
1 secondary outcome
the average amount of stool per day(g/Day)
Time frame: the 4th, 8th, 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 26834374Wang JS, Lee SB, Park SY. The effect of SSP therapy on elderly nursing home residents' chronic constipation. J Phys Ther Sci. 2015 Dec;27(12):3887-9. doi: 10.1589/jpts.27.3887. Epub 2015 Dec 28.
- Background: PubMed 19818748Moriya R, Fujikawa T, Ito J, Shirakura T, Hirose H, Suzuki J, Fukuroda T, Macneil DJ, Kanatani A. Pancreatic polypeptide enhances colonic muscle contraction and fecal output through neuropeptide Y Y4 receptor in mice. Eur J Pharmacol. 2010 Feb 10;627(1-3):258-64. doi: 10.1016/j.ejphar.2009.09.057. Epub 2009 Oct 8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Paralytic Ileus
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture group in people with Paralytic Ileus, run by China Medical University 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 5 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Liang Hsieh, professor (+886-4-22053366 ext. 3500, clhsieh@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changing of diameter of colon (KUB) (time frame: the 4th, 8th, 12th week). 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 NCT03041675, which also lists 2 linked publications.
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 7 Feb 2017.