Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction: a Prospective Double-blind Randomized Controlled Trial

Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of admission after intra-abdominal surgery. To date, the ideal management of ASBO remains controversial. The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy in patients with ASBO.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Small Bowel Obstruction
• Intervention / Treatment: Procedure: Laser acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Ting Liu, MD; Phone Number: 2334 +886-7-7317123; Email: juntin0214@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Chun-Ting Liu, MD; Phone Number: 2334 +886-7-7317123; Email: juntin0214@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 20 to 80 years
• Clinical symptoms and signs of mechanical obstruction

Exclusion Criteria:

• Clear non-adhesive etiology of small bowel obstruction (e.g. tumor, hernia)
• Emergency surgical intervention before being admitted to the hospital
• Pregnancy
• Local skin infection on the acupoints, and limb amputees.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; The subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group.	Procedure: Laser acupuncture; Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
Experimental: LA group; The subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), PC6 (Neiguan, B3), ST25 (Tianshu, B3), ST36 (Zusanli, B2), CV4 (Guanyuan), CV12 (Zhongwan, B3).	Procedure: Laser acupuncture; Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of conservative treatment	Defined as no need for long term nasogastric tube decompression and operative intervention.	2 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to oral intake	Defined as participants can try intake due to symptoms improved including nausea, vomiting, distension and pain.	2 weeks
Length of hospital stay	Date from admission to discharge	Through study completion, an average of 1 year
Serum lipase	Serum lipase	Up to 2 weeks
Serum amylase	Serum amylase	Up to 2 weeks
Serum cortisol	Serum cortisol	Up to 2 weeks
Serum motilin	Serum motilin	Up to 2 weeks
Serum ghrelin	Serum ghrelin	Up to 2 weeks
Serum intestinal fatty acid binding protein (I-FABP)	Serum intestinal fatty acid binding protein (I-FABP)	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chun-Ting Liu, MD, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Shih CH, Hsieh TM, Wu BY, Liu CT. Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial. Medicine (Baltimore). 2021 Mar 5;100(9):e25035. doi: 10.1097/MD.0000000000025035.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Laser acupuncture; Adhesive small bowel obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: CMRPG8K0571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No