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Effects of Laser Acupuncture Therapy on Paralytic Ileus

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ClinicalTrials.gov Identifier: NCT03041675
Recruitment Status : Unknown
Verified February 2017 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 13, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : August 31, 2017


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.




Primary Outcome Measures :
  1. the changing of diameter of colon (KUB) [ Time Frame: 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) [ Time Frame: the 4th, 8th, 12th week ]
    Is the average amount of stool per day elevating in laser group?


Other Outcome Measures:
  1. bowel sound [ Time Frame: the 4th, 8th, 12th week ]
    Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture

  2. frequency of enema [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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?



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041675


Contacts
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Contact: Ching-Liang Hsieh, professor +886-4-22053366 ext 3500 clhsieh@mail.cmuh.org.tw
Contact: SZU YU LIU, Doctor +886-975829732 m90641@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Ching-Liang Hsieh, professor    +886-4-22053366 ext 3500    clhsieh@mail.cmuh.org.tw   
Contact: SZU YU LIU, Doctor    +886-975829732    m90641@gmail.com   
Sponsors and Collaborators
China Medical University Hospital

Additional Information:
Publications:
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03041675     History of Changes
Other Study ID Numbers: CMUH105-REC1-133
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ileus
Intestinal Pseudo-Obstruction
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases