Effect of Laser Acupuncture on Obesity

Obesity Clinical Trial

Official title:

Effect of Laser Acupuncture on Obesity: a Patient-Assessor-Blinded, Randomized, Sham-controlled Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02167308
• Other study ID #: 103-1403A3
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2014
• Last updated: June 17, 2014
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: June 2014
• Source: Chang Gung Memorial Hospital
• Contact: Chi-Chuan Tseng, MD
• Phone: +886975353410
• Email: acupmox[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background: Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded, or included low-calorie diet control. Investigators have therefore designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity.

Methods/design: One hundred and four subjects above 20 years of age with a body mass index (BMI) of over 25 kg/m2 will be divided into two groups: experimental and control. Each subject will receive the treatment relevant to their group three times a week for eight weeks. After eight weeks of treatment the subject will enter a two week washout period, after which the subjects will switch groups. Measurements will include BMI, body fat percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh circumference, body fat, blood pressure, heart rate, hunger, and the 36-item short-form health survey (SF-36).

Discussion: The results of this pilot study will provide the basis for future large-scale multicenter trials investigating the effects of laser acupuncture on obesity.

Description:

The number of obese people around the world has been increasing rapidly. It has been estimated that over 10% of the world's adult population are obese. Obesity is associated with increased risk of coronary heart disease, type II diabetes, stroke, osteoarthritis, and certain types of cancer. These deleterious conditions are detrimental to individuals' quality of life, and places emotional and financial burden on the individual, their families, and society as a whole. Much more needs to be done to improve treatments for obesity.

Current methods to treat obesity include dietary intervention, lifestyle intervention, drug intervention, or bariatric surgery. Among these, acupuncture, in a comprehensive program for weight loss, has been increasing in popularity. However, previous systematic reviews assessing the effects of acupuncture on obesity discovered promising but inconclusive results. The low quality methodology used in those trials further reduced the strength of those conclusions. In addition, the lack of safety procedures used in traditional manual acupuncture could lead to adverse events such as retroperitoneal abscess, rapid dermal spread of breast cancer, pneumothorax, cardiac tamponade, viral hepatitis, and granuloma.

In comparison with traditional manual acupuncture, laser acupuncture therapy has several advantages. These advantages include ease of application, precision in dose measurement, painlessness, and non-invasiveness. It is a quick and safe therapy with low cost and no risk of infection. As laser acupuncture does not produce local sensation, double blind randomized controlled studies are also much easier to perform.

Laser acupuncture has been widely used in medical fields for over 30 years. Clinical research on the efficacy of laser acupuncture has also increased. Several studies have showed that laser acupuncture could be an effective treatment of obesity. Low-level laser therapy as a non-invasive approach for body contouring and spot fat reduction has also been reported. However, there are several experimental limitations that have to be considered. For instance, absence of placebo (sham) control, combination with low-calorie diet, and lack of sufficient comparative parameters have been questioned . For these reasons, investigators decided to conduct a patient-assessor-blinded, randomized, sham-controlled crossover pilot trial to investigate the effects of laser acupuncture with Gallium Aluminum Arsenide (GaAlAs) laser irradiation on weight loss, fat reduction, body contouring, and quality of life in people suffering from obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Individuals are eligible if they are above 20 years of age and have a BMI over 25 kg/m2. BMI cutoffs were adopted from a proposed classification of weight by BMI in adult Asians, including the obese I (BMI: 25-29.9 kg/m2) and obese II (BMI =30 kg/m2) categories.

Exclusion Criteria:

• cardiovascular disease

• diabetes

• endocrine abnormalities

• renal disease

• contagious skin condition

• epilepsy

• tumor

• mental disorder

• pregnant

• photosensitivity reactions to laser treatment

• uses a pacemaker

• used medications known to affect one's weight up to one month in advance

• un-willing to comply with the study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Laser acupuncture
a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Chiayi County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin fold thickness		week 26	No
Other	Thigh circumference		week 26	No
Other	Blood pressure		week 26	No
Other	Heart rate		week 26	No
Primary	BMI change from baseline		week 26	No
Secondary	Body fat percentage		week 26	No
Secondary	Waist-to-Hip ratio (WHR)		week 26	No
Secondary	Hunger	For hunger, a Visual Analogue Scale (VAS) with horizontal lines will be used, graded from 0 mm, representing no hunger, to 100 mm, representing the most extreme hunger imaginable. Subjects will be asked to mark their level of hunger on the VAS.	week 26	No
Secondary	Quality of life	Will be assessed via validated questionnaire (short-form 36-item Health Survey, SF36)	week 26	No