The Effect Evaluation of Laser Acupuncture in Obesity

Not Applicable

• Conditions: Obesity
• Interventions: Device: Handylaser Trion laser acupuncture

• Registration Number: NCT01975168
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-23
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male

Exclusion Criteria

• Pathmakers user
• Epilepsy history
• Pregnancy
• Immuno-inhibiting agents user
• Malignancy
• Skin contacted disease
• Weight controlled agents user during trial period
• Eating disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Handylaser Trion laser acupuncture	arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks
Group 2	Handylaser Trion laser acupuncture	arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks

Primary Outcome Measures

Name	Time	Method
body composition	12 weeks	body weight

Secondary Outcome Measures

Name	Time	Method
body mass index	12 weeks

Trial Locations

Locations (1)

Chinese Medicine Department Clinic, Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan