Effects of Laser Acupuncture Therapy on Paralytic Ileus

Paralytic Ileus Clinical Trial

Official title:

Effects of Laser Acupuncture Therapy on Paralytic Ileus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041675
• Other study ID #: CMUH105-REC1-133
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2017
• Last updated: February 5, 2017
• Start date: February 13, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: February 2017
• Source: China Medical University Hospital
• Contact: Ching-Liang Hsieh, professor
• Phone: +886-4-22053366
• Email: clhsieh[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: August 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ileus
• Intestinal Pseudo-Obstruction
• Paralytic Ileus

Intervention

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 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bowel sound	Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture	the 4th, 8th, 12th week
Other	frequency of enema	Is frequency of enema decreasing in laser group?(Indication of enema: the amount of	the 4th, 8th, 12th week
Other	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
Other	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
Other	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
Primary	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	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

External Links

•   Link