NCT03041675

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

January 23, 2017

Last Update Submit

February 5, 2017

Conditions

Paralytic Ileus

Keywords

Lacer AcupunctureParalytic ileus

Outcome Measures

Primary Outcomes (1)

  • 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?

    the 4th, 8th, 12th week

Secondary Outcomes (1)

  • the average amount of stool per day(g/Day)

    the 4th, 8th, 12th week

Other Outcomes (5)

  • bowel sound

    the 4th, 8th, 12th week

  • frequency of enema

    the 4th, 8th, 12th week

  • serum Gastrin (pmol/L) elevation

    the 4th, 8th, 12th week

  • +2 more other outcomes

Study Arms (2)

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.

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.

Device: Sham Laser Acupuncture group

Interventions

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.

Laser Acupuncture group
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.

Sham Laser Acupuncture group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant.
  • Patients taking immunosuppressive or morphine analgesics.
  • Skin infections.
  • Without test consent permit.
  • mechanical ileus, mechanical obstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26834374BACKGROUND

  • Moriya 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.

    PMID: 19818748BACKGROUND

Related Links

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Condition Hierarchy (Ancestors)

IleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Ching-Liang Hsieh, professor

CONTACT

+886-4-22053366clhsieh@mail.cmuh.org.tw

SZU YU LIU, Doctor

CONTACT

+886-975829732m90641@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 3, 2017

Study Start

February 13, 2017

Primary Completion

June 30, 2017

Study Completion

August 31, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)