The Effect of Electroacupuncture on Obesity

Sponsor

Kyunghee University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01102075

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Electroacupuncture Device: Sham electroacupuncture procedure	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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 Names:

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.

Outcome Measures

Primary Outcome Measures

waist circumference [At 5 weeks (post treatment)]

Secondary Outcome Measures

Thickness of abdominal subcutaneous fat [Study Day 1 (Baseline)]
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat [At 3weeks]
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat [At 5weeks (post treatment)]
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Thickness of abdominal subcutaneous fat [At 8weeks after first treatment (follow up)]
Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).
Waist hip ratio [Study Day 1 (Baseline)]
Waist hip ratio [At 3weeks]
Waist hip ratio [At 5weeks (post treatment)]
Waist hip ratio [At 8weeks after first treatment (follow up)]
Body Mass Index [Study Day 1 (Baseline)]
Body Mass Index was measured by Inbody 720
Body Mass Index [At 3weeks]
Body Mass Index was measured by Inbody 720
Body Mass Index [At 5weeks (post treatment)]
Body Mass Index was measured by Inbody 720
Body Mass Index [At 8weeks after first treatment (follow up)]
Body Mass Index was measured by Inbody 720
Body fat ratio [Study Day 1 (Baseline)]
Body fat ratio was measured by Inbody 720
Body fat ratio [At 3weeks]
Body fat ratio was measured by Inbody 720
Body fat ratio [At 5weeks (post treatment)]
Body fat ratio was measured by Inbody 720
Body fat ratio [At 8weeks after first treatment (follow up)]
Body fat ratio was measured by Inbody 720
Visceral Fat Area [Study Day 1 (Baseline)]
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area [At 3weeks]
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area [At 5weeks (post treatment)]
Visceral Fat Area was measured by Inbody 720
Visceral Fat Area [At 8weeks after first treatment (follow up)]
Visceral Fat Area was measured by Inbody 720
Body weight [Study Day 1 (Baseline)]
Body weight was measured by Inbody 720
Body weight [At 3weeks]
Body weight was measured by Inbody 720
Body weight [At 5weeks (post treatment)]
Body weight was measured by Inbody 720
Body weight [At 8weeks after first treatment (follow up)]
Body weight was measured by Inbody 720
Obesity degree [Study Day 1 (Baseline)]
Obesity degree was measured by Inbody 720
Obesity degree [At 3weeks]
Obesity degree was measured by Inbody 720
Obesity degree [At 5weeks (post treatment)]
Obesity degree was measured by Inbody 720
Obesity degree [At 8weeks after first treatment (follow up)]
Obesity degree was measured by Inbody 720
Bulimia Test Revised [Study Day 1 (Baseline)]
Bulimia Test Revised [At 5weeks (post treatment)]
Korean version of Obesity-related QOL scale [Study Day 1 (Baseline)]
Korean version of Obesity-related QOL scale [At 5weeks (post treatment)]
Body Shape Questionnaire [Study Day 1 (Baseline)]
Body Shape Questionnaire [At 5weeks (post treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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