The Effect of Electroacupuncture on Obesity

NCT01102075 | Unknown Phase 2 DMC

• 1 other identifier: KOMC MIRB 2009-6
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Electroacupuncture; Sham electroacupuncture; Waist circumference; Thickness of subcutaneous fat

Outcome Measures

Primary Outcomes (1)

• waist circumference

  At 5 weeks (post treatment)

Secondary Outcomes (34)

• Thickness of abdominal subcutaneous fat

  Study Day 1 (Baseline)

• Thickness of abdominal subcutaneous fat

  At 3weeks

• Thickness of abdominal subcutaneous fat

  At 5weeks (post treatment)

• Thickness of abdominal subcutaneous fat

  At 8weeks after first treatment (follow up)

• Waist hip ratio

  Study Day 1 (Baseline)

Study Arms (3)

Electroacupuncture

EXPERIMENTAL

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

Sham electroacupuncture procedure

SHAM COMPARATOR

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

Waiting list

NO INTERVENTION

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

Interventions

Electroacupuncture DEVICE

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)

Also known as: EA group

Electroacupuncture

Sham electroacupuncture procedure DEVICE

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)

Also known as: Sham EA group

Sham electroacupuncture procedure

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Kyunghee University Medical Center

Seoul, Hoegi-dong, Dongdaemun-gu, 130-702, South Korea

Location

Related Publications (3)

• 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.

  PMID: 19394499 BACKGROUND

• 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.

  PMID: 18719995 BACKGROUND

• 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.

  PMID: 15925954 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Sung Keel Kang, Doctor

  Kyunghee University Medical Center Oriental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 12, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 12, 2010

Record last verified: 2009-09

Locations

KR (1)