search
Back to results

The Effect of Electroacupuncture on Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electroacupuncture
Sham electroacupuncture procedure
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Electroacupuncture, Sham electroacupuncture, Waist circumference, Thickness of subcutaneous fat

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Waist circumference: Male>= 90 cm, Female >= 85 cm
  • BMI over than 25kg/m2

Exclusion Criteria:

  • Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc.
  • Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
  • Hypertension, hyperlipidemia or hypercholesterinemia patients on medication
  • Stroke or otherwise unable to exercise
  • Pregnant or lactating women
  • Childbirth within 6 months
  • Management for weight control within 3 months
  • Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge

Sites / Locations

  • Kyunghee University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Electroacupuncture

Sham electroacupuncture procedure

Waiting list

Arm Description

The Electroacupuncture therapy protocol included a total of 12 acupuncture points at the CV12,CV6, bilateral ST25, SP15, SP14,LI4, LI11, ST36, ST44. All acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Abdominal acupuncture points were inserted horizontally 6~6.5cm in depth and the others were inserted vertically 2~2.5cm in depth until patient can feel De-Qi. All acupuncture points were stimulated electrically with a frequency of 24 Hz an intensity of 0.27-1.3mA(tolerable strength) with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks by practitioner who had had 6 years of acupuncture training and 3 more years of clinical experience.

The Sham electroacupuncture therapy protocol(Non-acupoint, No electrical stimulation)included the same number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment, but superficially at non acupuncture points 15 mm to the lateral of each acupuncture point was treated. The points were not stimulated electrically, but the sound of the pulse generator was heard by the participants. (Lee SH, LeeBC 2009) Those receiving EA or SEA therapy were treated on alternate days to prevent crosstalk among groups, which could have compromised the blinded study design.

No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.

Outcomes

Primary Outcome Measures

waist circumference

Secondary Outcome Measures

Thickness of abdominal subcutaneous fat
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Waist hip ratio
Waist hip ratio
Waist hip ratio
Waist hip ratio
Body Mass Index
Body Mass Index was measured by Inbody 720
Body Mass Index
Body Mass Index was measured by Inbody 720
Body Mass Index
Body Mass Index was measured by Inbody 720
Body Mass Index
Body Mass Index was measured by Inbody 720
Body fat ratio
Body fat ratio was measured by Inbody 720
Body fat ratio
Body fat ratio was measured by Inbody 720
Body fat ratio
Body fat ratio was measured by Inbody 720
Body fat ratio
Body fat ratio was measured by Inbody 720
Visceral Fat Area
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area
Visceral Fat Area was measured by Inbody 720
Body weight
Body weight was measured by Inbody 720
Body weight
Body weight was measured by Inbody 720
Body weight
Body weight was measured by Inbody 720
Body weight
Body weight was measured by Inbody 720
Obesity degree
Obesity degree was measured by Inbody 720
Obesity degree
Obesity degree was measured by Inbody 720
Obesity degree
Obesity degree was measured by Inbody 720
Obesity degree
Obesity degree was measured by Inbody 720
Bulimia Test Revised
Bulimia Test Revised
Korean version of Obesity-related QOL scale
Korean version of Obesity-related QOL scale
Body Shape Questionnaire
Body Shape Questionnaire

Full Information

First Posted
April 6, 2010
Last Updated
April 9, 2010
Sponsor
Kyunghee University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01102075
Brief Title
The Effect of Electroacupuncture on Obesity
Official Title
The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.
Detailed Description
Many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(Wang F. et al. 2008)Recently conducted systematic review of Pittler and Ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. However, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. In this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Electroacupuncture, Sham electroacupuncture, Waist circumference, Thickness of subcutaneous fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
The Electroacupuncture therapy protocol included a total of 12 acupuncture points at the CV12,CV6, bilateral ST25, SP15, SP14,LI4, LI11, ST36, ST44. All acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Abdominal acupuncture points were inserted horizontally 6~6.5cm in depth and the others were inserted vertically 2~2.5cm in depth until patient can feel De-Qi. All acupuncture points were stimulated electrically with a frequency of 24 Hz an intensity of 0.27-1.3mA(tolerable strength) with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks by practitioner who had had 6 years of acupuncture training and 3 more years of clinical experience.
Arm Title
Sham electroacupuncture procedure
Arm Type
Sham Comparator
Arm Description
The Sham electroacupuncture therapy protocol(Non-acupoint, No electrical stimulation)included the same number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment, but superficially at non acupuncture points 15 mm to the lateral of each acupuncture point was treated. The points were not stimulated electrically, but the sound of the pulse generator was heard by the participants. (Lee SH, LeeBC 2009) Those receiving EA or SEA therapy were treated on alternate days to prevent crosstalk among groups, which could have compromised the blinded study design.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA group
Intervention Description
We used Electrical stimulator(STN-111,Stratek)with a frequency of 24 Hz and intensity of 0.27-1.3mA(tolerable strength), asymmetric interactive pulse with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks(10 sessions) by practitioner.(n=13)
Intervention Type
Device
Intervention Name(s)
Sham electroacupuncture procedure
Other Intervention Name(s)
Sham EA group
Intervention Description
We used same electroacupuncture device, number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment. Specific details are as described in the arm description.(n=13)
Primary Outcome Measure Information:
Title
waist circumference
Time Frame
At 5 weeks (post treatment)
Secondary Outcome Measure Information:
Title
Thickness of abdominal subcutaneous fat
Description
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Time Frame
Study Day 1 (Baseline)
Title
Thickness of abdominal subcutaneous fat
Description
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Time Frame
At 3weeks
Title
Thickness of abdominal subcutaneous fat
Description
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Time Frame
At 5weeks (post treatment)
Title
Thickness of abdominal subcutaneous fat
Description
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Time Frame
At 8weeks after first treatment (follow up)
Title
Waist hip ratio
Time Frame
Study Day 1 (Baseline)
Title
Waist hip ratio
Time Frame
At 3weeks
Title
Waist hip ratio
Time Frame
At 5weeks (post treatment)
Title
Waist hip ratio
Time Frame
At 8weeks after first treatment (follow up)
Title
Body Mass Index
Description
Body Mass Index was measured by Inbody 720
Time Frame
Study Day 1 (Baseline)
Title
Body Mass Index
Description
Body Mass Index was measured by Inbody 720
Time Frame
At 3weeks
Title
Body Mass Index
Description
Body Mass Index was measured by Inbody 720
Time Frame
At 5weeks (post treatment)
Title
Body Mass Index
Description
Body Mass Index was measured by Inbody 720
Time Frame
At 8weeks after first treatment (follow up)
Title
Body fat ratio
Description
Body fat ratio was measured by Inbody 720
Time Frame
Study Day 1 (Baseline)
Title
Body fat ratio
Description
Body fat ratio was measured by Inbody 720
Time Frame
At 3weeks
Title
Body fat ratio
Description
Body fat ratio was measured by Inbody 720
Time Frame
At 5weeks (post treatment)
Title
Body fat ratio
Description
Body fat ratio was measured by Inbody 720
Time Frame
At 8weeks after first treatment (follow up)
Title
Visceral Fat Area
Description
Visceral Fat Area was measured by Inbody 720
Time Frame
Study Day 1 (Baseline)
Title
Visceral Fat Area
Description
Visceral Fat Area was measured by Inbody 720
Time Frame
At 3weeks
Title
Visceral Fat Area
Description
Visceral Fat Area was measured by Inbody 720
Time Frame
At 5weeks (post treatment)
Title
Visceral Fat Area
Description
Visceral Fat Area was measured by Inbody 720
Time Frame
At 8weeks after first treatment (follow up)
Title
Body weight
Description
Body weight was measured by Inbody 720
Time Frame
Study Day 1 (Baseline)
Title
Body weight
Description
Body weight was measured by Inbody 720
Time Frame
At 3weeks
Title
Body weight
Description
Body weight was measured by Inbody 720
Time Frame
At 5weeks (post treatment)
Title
Body weight
Description
Body weight was measured by Inbody 720
Time Frame
At 8weeks after first treatment (follow up)
Title
Obesity degree
Description
Obesity degree was measured by Inbody 720
Time Frame
Study Day 1 (Baseline)
Title
Obesity degree
Description
Obesity degree was measured by Inbody 720
Time Frame
At 3weeks
Title
Obesity degree
Description
Obesity degree was measured by Inbody 720
Time Frame
At 5weeks (post treatment)
Title
Obesity degree
Description
Obesity degree was measured by Inbody 720
Time Frame
At 8weeks after first treatment (follow up)
Title
Bulimia Test Revised
Time Frame
Study Day 1 (Baseline)
Title
Bulimia Test Revised
Time Frame
At 5weeks (post treatment)
Title
Korean version of Obesity-related QOL scale
Time Frame
Study Day 1 (Baseline)
Title
Korean version of Obesity-related QOL scale
Time Frame
At 5weeks (post treatment)
Title
Body Shape Questionnaire
Time Frame
Study Day 1 (Baseline)
Title
Body Shape Questionnaire
Time Frame
At 5weeks (post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Waist circumference: Male>= 90 cm, Female >= 85 cm BMI over than 25kg/m2 Exclusion Criteria: Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc. Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker Hypertension, hyperlipidemia or hypercholesterinemia patients on medication Stroke or otherwise unable to exercise Pregnant or lactating women Childbirth within 6 months Management for weight control within 3 months Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Keel Kang, Doctor
Organizational Affiliation
Kyunghee University Medical Center Oriental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyunghee University Medical Center
City
Seoul
State/Province
Hoegi-dong, Dongdaemun-gu
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19394499
Citation
Lee SH, Lee BC. Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology. 2009 May;73(5):1036-41. doi: 10.1016/j.urology.2008.10.047.
Results Reference
background
PubMed Identifier
18719995
Citation
Wang F, Tian DR, Han JS. Electroacupuncture in the treatment of obesity. Neurochem Res. 2008 Oct;33(10):2023-7. doi: 10.1007/s11064-008-9822-6. Epub 2008 Aug 22.
Results Reference
background
PubMed Identifier
15925954
Citation
Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review. Int J Obes (Lond). 2005 Sep;29(9):1030-8. doi: 10.1038/sj.ijo.0803008.
Results Reference
background

Learn more about this trial

The Effect of Electroacupuncture on Obesity

We'll reach out to this number within 24 hrs