Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2014-06-30
2016-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Laser acupuncture group
Subjects will receive 24 activated laser acupuncture treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points.
Laser acupuncture
a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.
Control group
Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output. Acupuncture points, application duration, and total number of treatments will be identical to the Laser acupuncture group.
Laser acupuncture
a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.
Interventions
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Laser acupuncture
a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Chi-chuan Tseng
MD
Principal Investigators
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Chi-Chuan Tseng, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Chiayi County, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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103-1403A3
Identifier Type: -
Identifier Source: org_study_id
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