Effects of Laser Acupuncture Therapy on Paralytic Ileus

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.

Study Overview

• Status: Unknown
• Conditions: Paralytic Ileus
• Intervention / Treatment: Device: Laser Acupuncture group; Device: Sham Laser Acupuncture group

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:

1. KUB,
2. the average amount of stool every day,
3. frequency of bowel sound,
4. frequency of enema, (Indication of enema: the amount of stool less than 200g within 3 days),
5. the change of serum Gastrin, Motilin, and Pancreatic polypeptide.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Liang Hsieh, professor; Phone Number: 3500 +886-4-22053366; Email: clhsieh@mail.cmuh.org.tw
• Study Contact Backup: Name: SZU YU LIU, Doctor; Phone Number: +886-975829732; Email: m90641@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital
    • Contact: Ching-Liang Hsieh, professor; Phone Number: 3500 +886-4-22053366; Email: clhsieh@mail.cmuh.org.tw
    • Contact: SZU YU LIU, Doctor; Phone Number: +886-975829732; Email: m90641@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Acupuncture group; 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; 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 Comparator: Sham Laser Acupuncture group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the average amount of stool per day(g/Day)	Is the average amount of stool per day elevating in laser group?	the 4th, 8th, 12th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
bowel sound	Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture	the 4th, 8th, 12th week
frequency of enema	Is frequency of enema decreasing in laser group?(Indication of enema: the amount of	the 4th, 8th, 12th week
serum Gastrin (pmol/L) elevation	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?	the 4th, 8th, 12th week
serum Motilin (pmol/L) elevation	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?	the 4th, 8th, 12th week
serum Pancreatic polypeptide (pmol/L) elevation	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?	the 4th, 8th, 12th week

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): February 13, 2017
• Primary Completion (Anticipated): June 30, 2017
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Lacer Acupuncture; Paralytic ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Intestinal Pseudo-Obstruction
• Other Study ID Numbers: CMUH105-REC1-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No