Effects of Laser Acupuncture Therapy on Paralytic Ileus

Study Overview
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Brief Summary
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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
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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: KUB, the average amount of stool every day, frequency of bowel sound, frequency of enema, (Indication of enema: the amount of stool less than 200g within 3 days), the change of serum Gastrin, Motilin, and Pancreatic polypeptide.

Official Title
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Effects of Laser Acupuncture Therapy on Paralytic Ileus

Conditions
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Paralytic Ileus

Intervention / Treatment
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* Device: Laser Acupuncture group
* Device: Sham Laser Acupuncture group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Acupuncture group<br>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<br>* 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.<br>|
| Sham Comparator: Sham Laser Acupuncture group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacer Acupuncture, Paralytic ileus