Clinical trial NCT03041675: Effects of Laser Acupuncture Therapy on Paralytic Ileus
Official title: Effects of Laser Acupuncture Therapy on Paralytic Ileus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paralytic Ileus
Keywords: Lacer Acupuncture
Paralytic ileus
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the changing of diameter of colon (KUB)
timeFrame: the 4th, 8th, 12th week
Secondary outcomes:
measure: the average amount of stool per day(g/Day)
timeFrame: the 4th, 8th, 12th week
Other outcomes:
measure: bowel sound
timeFrame: the 4th, 8th, 12th week
measure: frequency of enema
timeFrame: the 4th, 8th, 12th week
measure: serum Gastrin (pmol/L) elevation
timeFrame: the 4th, 8th, 12th week
measure: serum Motilin (pmol/L) elevation
timeFrame: the 4th, 8th, 12th week
measure: serum Pancreatic polypeptide (pmol/L) elevation
timeFrame: the 4th, 8th, 12th week
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
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: 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.