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Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Primary Purpose

Adhesive Small Bowel Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Small Bowel Obstruction focused on measuring Adhesive small bowel obstruction, Laser acupuncture, Acupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LA group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Success rate of conservative treatment
Defined as no need for long term nasogastric tube decompression and operative intervention.

Secondary Outcome Measures

Time to oral intake
Defined as participants can try intake due to symptoms improved including nausea, vomiting, distension and pain.
Length of hospital stay
Date from admission to discharge
Serum lipase
Serum lipase
Serum amylase
Serum amylase
Serum cortisol
Serum cortisol
Serum motilin
Serum motilin
Serum ghrelin
Serum ghrelin
Serum intestinal fatty acid binding protein (I-FABP)
Serum intestinal fatty acid binding protein (I-FABP)

Full Information

First Posted
March 16, 2020
Last Updated
March 8, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04318821
Brief Title
Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction
Official Title
Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction: a Prospective Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Small Bowel Obstruction
Keywords
Adhesive small bowel obstruction, Laser acupuncture, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The participants in each group will receive real (with energy output) or sham (without energy output) laser acupuncture. The feelings of participants in each group are not different. The care provider and outcomes assessor don't involve the random allocation and don't know if participants receive real laser acupuncture.
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LA group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture
Intervention Description
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
Primary Outcome Measure Information:
Title
Success rate of conservative treatment
Description
Defined as no need for long term nasogastric tube decompression and operative intervention.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Time to oral intake
Description
Defined as participants can try intake due to symptoms improved including nausea, vomiting, distension and pain.
Time Frame
2 weeks
Title
Length of hospital stay
Description
Date from admission to discharge
Time Frame
Through study completion, an average of 1 year
Title
Serum lipase
Description
Serum lipase
Time Frame
Up to 2 weeks
Title
Serum amylase
Description
Serum amylase
Time Frame
Up to 2 weeks
Title
Serum cortisol
Description
Serum cortisol
Time Frame
Up to 2 weeks
Title
Serum motilin
Description
Serum motilin
Time Frame
Up to 2 weeks
Title
Serum ghrelin
Description
Serum ghrelin
Time Frame
Up to 2 weeks
Title
Serum intestinal fatty acid binding protein (I-FABP)
Description
Serum intestinal fatty acid binding protein (I-FABP)
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Organizational Affiliation
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33655978
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

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