Effects of Laser Acupuncture Therapy on Paralytic Ileus

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03041675
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 14.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paralytic Ileus	Device: Laser Acupuncture group; Device: Sham Laser Acupuncture group	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Laser Acupuncture Therapy on Paralytic Ileus
• Anticipated Study Start Date: Feb 13, 2017
• Anticipated Primary Completion Date: Jun 30, 2017
• Anticipated Study Completion Date: Aug 31, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. the changing of diameter of colon (KUB) [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?

Secondary Outcome Measures

1. the average amount of stool per day(g/Day) [the 4th, 8th, 12th week]

   Is the average amount of stool per day elevating in laser group?

Other Outcome Measures

1. bowel sound [the 4th, 8th, 12th week]

   Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture

2. frequency of enema [the 4th, 8th, 12th week]

   Is frequency of enema decreasing in laser group?(Indication of enema: the amount of

3. serum Gastrin (pmol/L) elevation [the 4th, 8th, 12th week]

   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?

4. serum Motilin (pmol/L) elevation [the 4th, 8th, 12th week]

   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?

5. serum Pancreatic polypeptide (pmol/L) elevation [the 4th, 8th, 12th week]

   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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan	404

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• 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.
• 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.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT03041675
• Other Study ID Numbers: CMUH105-REC1-133
• First Posted: Feb 3, 2017
• Last Update Posted: Feb 7, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China Medical University Hospital: Lacer Acupuncture; Paralytic ileus
• Additional relevant MeSH terms: Ileus; Intestinal Pseudo-Obstruction

Study Results

No Results Posted as of Feb 7, 2017