Clinical trial NCT02167308: Effect of Laser Acupuncture on Obesity
Official title: Effect of Laser Acupuncture on Obesity: a Patient-Assessor-Blinded, Randomized, Sham-controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI change from baseline
timeFrame: week 26
Secondary outcomes:
measure: Body fat percentage
timeFrame: week 26
measure: Waist-to-Hip ratio (WHR)
timeFrame: week 26
measure: Hunger
timeFrame: week 26
measure: Quality of life
timeFrame: week 26
Other outcomes:
measure: Skin fold thickness
timeFrame: week 26
measure: Thigh circumference
timeFrame: week 26
measure: Blood pressure
timeFrame: week 26
measure: Heart rate
timeFrame: week 26
Locations:
city: Chiayi County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chi-Chuan Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tseng CC, Tseng A, Chang CH. Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial. Trials. 2015 May 15;16:217. doi: 10.1186/s13063-015-0748-4.