The Effect of Electroacupuncture on Obesity
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Kyunghee University Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Kyunghee University Medical Center
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01102075
First received: April 6, 2010
Last updated: April 9, 2010
Last verified: September 2009
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Purpose
The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Device: Electroacupuncture Device: Sham electroacupuncture procedure |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study |
Resource links provided by NLM:
Further study details as provided by Kyunghee University Medical Center:
Primary Outcome Measures:
- waist circumference [ Time Frame: At 5 weeks (post treatment) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Thickness of abdominal subcutaneous fat [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
- Thickness of abdominal subcutaneous fat [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
- Thickness of abdominal subcutaneous fat [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
- Thickness of abdominal subcutaneous fat [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
- Waist hip ratio [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]
- Waist hip ratio [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]
- Waist hip ratio [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]
- Waist hip ratio [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]
- Body Mass Index [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Body Mass Index was measured by Inbody 720
- Body Mass Index [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Body Mass Index was measured by Inbody 720
- Body Mass Index [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Body Mass Index was measured by Inbody 720
- Body Mass Index [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Body Mass Index was measured by Inbody 720
- Body fat ratio [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Body fat ratio was measured by Inbody 720
- Body fat ratio [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Body fat ratio was measured by Inbody 720
- Body fat ratio [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Body fat ratio was measured by Inbody 720
- Body fat ratio [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Body fat ratio was measured by Inbody 720
- Visceral Fat Area [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Visceral Fat Area was measured by Inbody 720
- Visceral Fat Area [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Visceral Fat Area was measured by Inbody 720
- Visceral Fat Area [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Visceral Fat Area was measured by Inbody 720
- Visceral Fat Area [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Visceral Fat Area was measured by Inbody 720
- Body weight [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Body weight was measured by Inbody 720
- Body weight [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Body weight was measured by Inbody 720
- Body weight [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Body weight was measured by Inbody 720
- Body weight [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Body weight was measured by Inbody 720
- Obesity degree [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]Obesity degree was measured by Inbody 720
- Obesity degree [ Time Frame: At 3weeks ] [ Designated as safety issue: Yes ]Obesity degree was measured by Inbody 720
- Obesity degree [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]Obesity degree was measured by Inbody 720
- Obesity degree [ Time Frame: At 8weeks after first treatment (follow up) ] [ Designated as safety issue: Yes ]Obesity degree was measured by Inbody 720
- Bulimia Test Revised [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]
- Bulimia Test Revised [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]
- Korean version of Obesity-related QOL scale [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]
- Korean version of Obesity-related QOL scale [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]
- Body Shape Questionnaire [ Time Frame: Study Day 1 (Baseline) ] [ Designated as safety issue: Yes ]
- Body Shape Questionnaire [ Time Frame: At 5weeks (post treatment) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 39 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Electroacupuncture
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.
|
Device: Electroacupuncture
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)
Other Name: EA group
|
|
Sham Comparator: Sham electroacupuncture procedure
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.
|
Device: Sham electroacupuncture procedure
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)
Other Name: Sham EA group
|
|
No Intervention: Waiting list
No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102075
Locations
| Korea, Republic of | |
| Kyunghee University Medical Center | |
| Seoul, Hoegi-dong, Dongdaemun-gu, Korea, Republic of, 130-702 | |
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
| Principal Investigator: | Sung Keel Kang, Doctor | Kyunghee University Medical Center Oriental Hospital |
More Information
Publications:
| Responsible Party: | Sung Keel Kang, Kyunghee University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01102075 History of Changes |
| Other Study ID Numbers: | KOMC MIRB 2009-6 |
| Study First Received: | April 6, 2010 |
| Last Updated: | April 9, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Kyunghee University Medical Center:
|
Obesity Electroacupuncture Sham electroacupuncture Waist circumference Thickness of subcutaneous fat |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013