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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

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date February 7, 2017
Estimated Study Start Date  ICMJE February 13, 2017
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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?
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 1, 2017)
  • bowel sound [ Time Frame: the 4th, 8th, 12th week ]
    Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture
  • frequency of enema [ Time Frame: the 4th, 8th, 12th week ]
    Is frequency of enema decreasing in laser group?(Indication of enema: the amount of
  • 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?
  • 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?
  • 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?
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Laser Acupuncture Therapy on Paralytic Ileus
Official Title  ICMJE Effects of Laser Acupuncture Therapy on Paralytic Ileus
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Paralytic Ileus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Laser Acupuncture group
  • 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.
    Intervention: Device: Sham Laser Acupuncture group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2017
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041675
Other Study ID Numbers  ICMJE CMUH105-REC1-133
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Medical University Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP