Effects of Laser Acupuncture Therapy on Paralytic Ileus

China Medical University

Status: Unknown

Conditions: Paralytic Ileus

Treatments: Device: Sham Laser Acupuncture group; Device: Laser Acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT03041675

CMUH105-REC1-133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups

Laser Acupuncture group

Experimental 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.

Treatment:

Device: Laser Acupuncture group

Sham Laser Acupuncture group

Sham Comparator 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.

Treatment:

Device: Sham Laser Acupuncture group