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Effects of Laser Acupuncture Therapy on Paralytic Ileus

Primary Purpose

Paralytic Ileus

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser Acupuncture group
Sham Laser Acupuncture group
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralytic Ileus focused on measuring Lacer Acupuncture, Paralytic ileus

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser Acupuncture group

Sham Laser Acupuncture group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

the average amount of stool per day(g/Day)
Is the average amount of stool per day elevating in laser group?

Full Information

First Posted
January 23, 2017
Last Updated
February 5, 2017
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03041675
Brief Title
Effects of Laser Acupuncture Therapy on Paralytic Ileus
Official Title
Effects of Laser Acupuncture Therapy on Paralytic Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2017 (Anticipated)
Primary Completion Date
June 30, 2017 (Anticipated)
Study Completion Date
August 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralytic Ileus
Keywords
Lacer Acupuncture, Paralytic ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser Acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Laser Acupuncture group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser Acupuncture group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Laser Acupuncture group
Intervention Description
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.
Primary Outcome Measure Information:
Title
the changing of diameter of colon (KUB)
Description
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?
Time Frame
the 4th, 8th, 12th week
Secondary Outcome Measure Information:
Title
the average amount of stool per day(g/Day)
Description
Is the average amount of stool per day elevating in laser group?
Time Frame
the 4th, 8th, 12th week
Other Pre-specified Outcome Measures:
Title
bowel sound
Description
Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture
Time Frame
the 4th, 8th, 12th week
Title
frequency of enema
Description
Is frequency of enema decreasing in laser group?(Indication of enema: the amount of
Time Frame
the 4th, 8th, 12th week
Title
serum Gastrin (pmol/L) elevation
Description
Gastrin is secreted by G cell at stomach. It stimulates parietal cells of the stomach to secrete hydrochloric acid (HCl)/gastric acid. It also increases antral muscle mobility and promotes stomach contractions. Collect serum 3cc before study, and on the end of 4th, 8th, 12th week. Check serum Gastrin. Is serum Gastrin increased after Laser Acupuncture Therapy?
Time Frame
the 4th, 8th, 12th week
Title
serum Motilin (pmol/L) elevation
Description
Motilin is secreted by endocrine M cells that are numerous in crypts of the small intestine, especially in the duodenum and jejunum. It's the most important factor in controlling the inter-digestive migrating contractions. Collect serum 3cc before study, and on the end of 4th, 8th, 12th week. Check serum Motilin. Is serum Motilin increased after Laser Acupuncture Therapy?
Time Frame
the 4th, 8th, 12th week
Title
serum Pancreatic polypeptide (pmol/L) elevation
Description
Pancreatic polypeptide is released mainly from the pancreas. Pancreatic polypeptide has been shown to stimulate colonic muscle contraction. Collect serum 3cc before study, and on the end of 4th, 8th, 12th week. Check serum Pancreatic polypeptide. Is serum Pancreatic polypeptide increased after Laser Acupuncture Therapy?
Time Frame
the 4th, 8th, 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnant. Patients taking immunosuppressive or morphine analgesics. Skin infections. Without test consent permit. mechanical ileus, mechanical obstruction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, professor
Phone
+886-4-22053366
Ext
3500
Email
clhsieh@mail.cmuh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
SZU YU LIU, Doctor
Phone
+886-975829732
Email
m90641@gmail.com
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, professor
Phone
+886-4-22053366
Ext
3500
Email
clhsieh@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
SZU YU LIU, Doctor
Phone
+886-975829732
Email
m90641@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26834374
Citation
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.
Results Reference
background
PubMed Identifier
19818748
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/19818748
Description
Related Info

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Effects of Laser Acupuncture Therapy on Paralytic Ileus

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