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临床试验/NCT02167308
NCT02167308Unknown不适用

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

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
104
试验地点
2
主要终点
BMI change from baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals are eligible if they are above 20 years of age and have a BMI over 25 kg/m
  • 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.

排除标准

  • cardiovascular disease
  • endocrine abnormalities
  • renal disease
  • contagious skin condition
  • mental disorder
  • 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

结局指标

主要结局

BMI change from baseline

时间窗: week 26

次要结局

  • Body fat percentage(week 26)
  • Waist-to-Hip ratio (WHR)(week 26)
  • Hunger(week 26)
  • Quality of life(week 26)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi-chuan Tseng

MD

Chang Gung Memorial Hospital

研究点 (2)

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