<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041675</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH105-REC1-133</org_study_id>
    <nct_id>NCT03041675</nct_id>
  </id_info>
  <brief_title>Effects of Laser Acupuncture Therapy on Paralytic Ileus</brief_title>
  <official_title>Effects of Laser Acupuncture Therapy on Paralytic Ileus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus&#xD;
      include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less&#xD;
      and less effective over time. Some study revealed that Moxibustion and Acupuncture are&#xD;
      effective in Paralytic ileus. Investigators try to find other treatment except of medicine.&#xD;
      Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of&#xD;
      Laser Acupuncture on Paralytic ileus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study's sample consisted of 94 adult participants who had Paralytic ileus. Patients&#xD;
      experiencing skin disease or wounds, pregnancy, less than 20 years old, and who take&#xD;
      Immunosuppressants drugs or Morphine, Mechanical obstruction were excluded. These 94 patients&#xD;
      were randomly divided into two groups: a Laser Acupuncture group and a control group. At the&#xD;
      beginning of study, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic&#xD;
      polypeptide, and record bowel sound per minute, frequent of enema, average amount of stool&#xD;
      per day. 47 patients received Laser Acupuncture therapy three times a week in acupoints RN6,&#xD;
      RN4, and RN12. The whole duration of treatment is 8 weeks. The control group patients receive&#xD;
      pseudo laser acupuncture. In the end of 4th and 8th week, check X-ray(KUB), collect serum&#xD;
      Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, observe the&#xD;
      daily record and then calculate frequent of enema and average amount of stool per day. After&#xD;
      the end of treatment, the investigators keep follow up for 4 weeks. The outcome parameters&#xD;
      include:&#xD;
&#xD;
        1. KUB,&#xD;
&#xD;
        2. the average amount of stool every day,&#xD;
&#xD;
        3. frequency of bowel sound,&#xD;
&#xD;
        4. frequency of enema, (Indication of enema: the amount of stool less than 200g within 3&#xD;
           days),&#xD;
&#xD;
        5. the change of serum Gastrin, Motilin, and Pancreatic polypeptide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 13, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the changing of diameter of colon (KUB)</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>Definition of Ileus: Diameter of colon: &gt;6cm. Check KUB on the 4th, 8th, 12th week. Calculate the biggest diameter of colon. Is diameter of colon decreasing in Laser Acupuncture group?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the average amount of stool per day(g/Day)</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>Is the average amount of stool per day elevating in laser group?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>bowel sound</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture</description>
  </other_outcome>
  <other_outcome>
    <measure>frequency of enema</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>Is frequency of enema decreasing in laser group?(Indication of enema: the amount of</description>
  </other_outcome>
  <other_outcome>
    <measure>serum Gastrin (pmol/L) elevation</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>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?</description>
  </other_outcome>
  <other_outcome>
    <measure>serum Motilin (pmol/L) elevation</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>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?</description>
  </other_outcome>
  <other_outcome>
    <measure>serum Pancreatic polypeptide (pmol/L) elevation</measure>
    <time_frame>the 4th, 8th, 12th week</time_frame>
    <description>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?</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Paralytic Ileus</condition>
  <arm_group>
    <arm_group_label>Laser Acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Laser Acupuncture group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Acupuncture group</intervention_name>
    <description>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.</description>
    <arm_group_label>Laser Acupuncture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Laser Acupuncture group</intervention_name>
    <description>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.</description>
    <arm_group_label>Sham Laser Acupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Already sign test consent permit.&#xD;
&#xD;
          -  More than 20-year-old.&#xD;
&#xD;
          -  Doctors diagnosis as Paralysis ileus, and KUB report was improved as Paralysis ileus&#xD;
             by Radiologists.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Patients taking immunosuppressive or morphine analgesics.&#xD;
&#xD;
          -  Skin infections.&#xD;
&#xD;
          -  Without test consent permit.&#xD;
&#xD;
          -  mechanical ileus, mechanical obstruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ching-Liang Hsieh, professor</last_name>
    <phone>+886-4-22053366</phone>
    <phone_ext>3500</phone_ext>
    <email>clhsieh@mail.cmuh.org.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>SZU YU LIU, Doctor</last_name>
    <phone>+886-975829732</phone>
    <email>m90641@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ching-Liang Hsieh, professor</last_name>
      <phone>+886-4-22053366</phone>
      <phone_ext>3500</phone_ext>
      <email>clhsieh@mail.cmuh.org.tw</email>
    </contact>
    <contact_backup>
      <last_name>SZU YU LIU, Doctor</last_name>
      <phone>+886-975829732</phone>
      <email>m90641@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/19818748</url>
    <description>Related Info</description>
  </link>
  <reference>
    <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. Epub 2015 Dec 28.</citation>
    <PMID>26834374</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19818748</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 5, 2017</last_update_submitted>
  <last_update_submitted_qc>February 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacer Acupuncture</keyword>
  <keyword>Paralytic ileus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
    <mesh_term>Intestinal Pseudo-Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041675
org study id: CMUH105-REC1-133
nct id: NCT03041675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the changing of diameter of colon (KUB)
time frame: the 4th, 8th, 12th week
description: 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?
measure: the average amount of stool per day(g/Day)
time frame: the 4th, 8th, 12th week
description: Is the average amount of stool per day elevating in laser group?
measure: bowel sound
time frame: the 4th, 8th, 12th week
description: Record frequency of bowel sound. Is bowel sound increased after Laser Acupuncture
measure: frequency of enema
time frame: the 4th, 8th, 12th week
description: Is frequency of enema decreasing in laser group?(Indication of enema: the amount of
measure: serum Gastrin (pmol/L) elevation
time frame: the 4th, 8th, 12th week
description: 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?
measure: serum Motilin (pmol/L) elevation
time frame: the 4th, 8th, 12th week
description: 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?
measure: serum Pancreatic polypeptide (pmol/L) elevation
time frame: the 4th, 8th, 12th week
description: 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?
arm group label: Laser Acupuncture group
arm group type: Experimental
description: 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.
arm group label: Sham Laser Acupuncture group
arm group type: Sham Comparator
description: 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 type: Device
intervention name: Laser Acupuncture group
description: 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.
arm group label: Laser Acupuncture group
intervention type: Device
intervention name: Sham Laser Acupuncture group
description: 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.
arm group label: Sham Laser Acupuncture group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ching-Liang Hsieh, professor
phone: +886-4-22053366
phone ext: 3500
email: clhsieh@mail.cmuh.org.tw
last name: SZU YU LIU, Doctor
phone: +886-975829732
email: m90641@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
url: https://www.ncbi.nlm.nih.gov/pubmed/19818748
description: Related Info
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. Epub 2015 Dec 28.
PMID: 26834374
citation: 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.
PMID: 19818748
responsible party type: Sponsor
mesh term: Ileus
mesh term: Intestinal Pseudo-Obstruction
sharing ipd: No