The Effect Evaluation of Laser Acupuncture in Obesity

Kaohsiung Medical University

Status: Unknown

Conditions: Obesity

Treatments: Device: Handylaser Trion laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01975168

KMUH-LAAC-OB-001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Group 1

Experimental group

Description:

arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks

Treatment:

Device: Handylaser Trion laser acupuncture

Group 2

Sham Comparator group

Description:

arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks

Treatment:

Device: Handylaser Trion laser acupuncture