ObesityNCT02167308
Effect of Laser Acupuncture on Obesity
A study testing Laser acupuncture in people with Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- cardiovascular disease
- diabetes
- endocrine abnormalities
- renal disease
- contagious skin condition
- epilepsy
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi County, 61363
Chi-Chuan Tseng, MD, +886975353410, acupmox@gmail.com
Chi-Chuan Tseng, MD
About this study
Official title: Effect of Laser Acupuncture on Obesity: a Patient-Assessor-Blinded, Randomized, Sham-controlled Crossover Trial
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Laser acupuncture
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture group | Active comparator | Subjects will receive 24 activated laser acupuncture treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points. Receives: Device: Laser acupuncture |
| Control group | Sham comparator | 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. Receives: Device: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI change from baseline
Measured: week 26
Secondary outcomes (4)
Body fat percentage
Measured: week 26
Waist-to-Hip ratio (WHR)
Measured: week 26
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.
Measured: week 26
Quality of life
Will be assessed via validated questionnaire (short-form 36-item Health Survey, SF36)
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-chuan Tseng, Chang Gung Memorial Hospital
- Investigators
- Chi-Chuan Tseng, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167308
- Sponsor's protocol ID
- 103-1403A3
- Status last verified
- Jun 2014
- First submitted
- 14 Jun 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25972018
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Obesity: a Patient-Assessor-Blinded, Randomized, Sham-controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT02167308
- Acronym / sponsor ID
- 103-1403A3
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture group | Active comparator | Device: Laser acupunctureSubjects will receive 24 activated laser acupuncture treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points. |
| Control group | Sham comparator | Device: Laser acupunctureSubjects 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- cardiovascular disease
- diabetes
- endocrine abnormalities
- renal disease
- contagious skin condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupuncturea GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode. | Device | Control group, Laser acupuncture group |
Primary outcome
BMI change from baseline
Time frame: week 26
4 secondary outcomes
Body fat percentage
Time frame: week 26
Waist-to-Hip ratio (WHR)
Time frame: week 26
Hunger
Time frame: week 26
Quality of life
Time frame: week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Derived from this study: PubMed 25972018Tseng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Chuan Tseng, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Chuan Tseng, MD (+886975353410, acupmox@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI change from baseline (time frame: week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02167308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.