Electro-acupuncture for Central Obesity

Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Central Obesity
• Intervention / Treatment: Other: acupuncture

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Kowloon Tong, Kowloon, Hong Kong
      • Linda Zhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; 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.	Other: acupuncture; 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.
Placebo Comparator: sham-acupuncture group; 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.	Other: acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in waist circumference	Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).	0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hip circumference	hip circumference measured at the level of maximum posterior extension of the buttocks	0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks
Adverse events after treatment and follow up	Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in waist-to-hip circumference ratio	waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in Body Mass Index	Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in body fat percentage	The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)	Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.	0, 8 weeks

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Collaborators: Princess Margaret Hospital, Hong Kong
• Investigators: Study Director: Zhaoxiang Bian, MD., Ph.D, Hong Kong Chinese Medicine Clinical Study Centre

Publications and helpful links

General Publications

• Zhong LLD, Wu X, Lam TF, Wong YP, Cao P, Wong EY, Zhang S, Bian Z. Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol. BMC Complement Med Ther. 2021 Jul 3;21(1):190. doi: 10.1186/s12906-021-03367-2.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 20, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: HKBU-HMRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No