Effects of Laser Acupuncture Therapy on Paralytic Ileus

Not Applicable

• Conditions: Paralytic Ileus
• Interventions: Device: Laser Acupuncture group; Device: Sham Laser Acupuncture group

• Registration Number: NCT03041675
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-23
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Submitted: 2017-02-05
• Last Update Posted: 2017-02-07
• Study Start: 2017-02-13
• Primary Completion: 2017-06-30
• Study Completion: 2017-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Acupuncture group	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 Laser Acupuncture group	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

Name	Time	Method
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

Name	Time	Method
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?

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan