Electro-acupuncture for Central Obesity

Hong Kong Baptist University

Status: Completed

Conditions: Central Obesity

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03815253

HKBU-HMRF

Details and patient eligibility

About

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Full description

This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Enrollment: 168 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion criteria

Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups, including a placebo group

Acupuncture group

Experimental group

Description:

Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks. Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.

Treatment:

Other: acupuncture

sham-acupuncture group

Placebo Comparator group

Description:

As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.

Treatment:

Other: acupuncture