Acupoint Embedding Combined With Laser Acupuncture for Obesity: A Randomized, Double-Blind, Sham Laser-Controlled Trial Evaluating Anthropometric, Biochemical, and Hemodynamic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Body Weight at Week 12
研究概览
简要总结
Acupoint catgut embedding and laser acupuncture have each been studied as treatments for obesity in adults, but the two have not been evaluated in combination, and few trials have measured anthropometric, biochemical, and blood pressure outcomes together.
This single-center randomized sham-controlled trial plans to enroll 120 adults aged 20 to 65 years with obesity. All participants receive the same acupoint catgut embedding with poliglecaprone 25 absorbable suture at 15 acupoints, comprising 25 insertions, once every 2 weeks for 6 sessions over 12 weeks. Participants are randomly assigned in a 1:1 ratio to receive, immediately before each embedding session, either active 810 nm laser acupuncture or sham laser acupuncture delivered with a device that is identical in appearance, indicator light, and operating sound but emits no therapeutic energy. Both groups also receive standardized dietary and exercise counseling.
Because the acupoint embedding regimen is identical in both groups and the groups differ only in whether the laser emits energy, the comparison estimates the incremental effect of laser acupuncture added to acupoint embedding. Participants are treated for 12 weeks and then followed for a further 12 weeks, to Week 24.
详细描述
Background
Acupoint catgut embedding and laser acupuncture have each accumulated clinical evidence as treatments for obesity in adults, but three gaps remain. First, the two have not been evaluated in combination. Second, few published trials measure anthropometric, biochemical, and blood pressure outcomes together. Third, most existing trials are small, and systematic reviews have repeatedly noted limitations in blinding and sham control. Supporting literature is listed under Citations.
Rationale for the design
Acupoint embedding delivers sustained mechanical stimulation as the suture degrades over several weeks, whereas laser acupuncture delivers an energy input at the time of each session. The two therefore differ in mechanism and in time course. By giving identical acupoint embedding to both groups and varying only whether the laser emits energy, the trial estimates the incremental effect attributable to laser acupuncture rather than the combined effect of the two therapies.
Masking
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The manufacturer supplies dedicated sham laser pens identical to the active pens in housing, red indicator light, and operating sound, but with the laser module disconnected so actual output is 0 milliwatts. Because 810 nm light is outside the visible range and safety goggles are worn, neither the participant nor the treating physician can tell the pens apart. The principal investigator personally performs the embedding and the laser application and is masked by this same mechanism, which is why the investigator role is recorded as masked. Pens are issued by serial number by a study coordinator who takes no part in treatment; the allocation code list is held sealed in the principal investigator's office and is opened only for a serious adverse event or a genuine medical emergency. Research assistants performing all measurements take no part in treatment and are not informed of allocation, and the statistician works from coded group labels until unmasking.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 65 years
- •Body mass index of 27 kg/m^2 or greater, or body mass index of 24 kg/m^2 or greater together with a waist circumference of 90 cm or greater in men or 80 cm or greater in women
- •Able to fully understand the informed consent document and willing to give written informed consent
- •No use of weight-loss medication and no other weight-reduction treatment in the 3 months before enrollment
- •Willing to follow the dietary and exercise advice given during the trial
排除标准
- •Current use of medication that may affect body weight, including corticosteroids, antipsychotics, insulin, or glucagon-like peptide-1 (GLP-1) receptor agonists
- •Known secondary cause of obesity, such as hypothyroidism, Cushing syndrome, or pituitary disease
- •Severe cardiovascular, hepatic, or renal disease, or poorly controlled diabetes defined as glycated hemoglobin (HbA1c) above 9 percent
- •Currently pregnant, breastfeeding, or planning pregnancy within 6 months
- •Bariatric surgery within the previous 6 months
- •Known allergy to absorbable suture material
- •Skin infection at the embedding sites, keloid tendency, or coagulation disorder
- •Implanted cardiac pacemaker or other electromagnetic implant
- •Known photosensitivity disorder or current use of photosensitizing medication
结局指标
主要结局
Mean Change From Baseline in Body Weight at Week 12
时间窗: Baseline and Week 12
Body weight in kilograms, measured on a calibrated scale by a trained assessor.
次要结局
- Mean Change From Baseline in Body Weight at Weeks 18 and 24(Baseline, Week 18, and Week 24)
- Mean Change From Baseline in Body Mass Index(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Waist Circumference(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Hip Circumference(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Waist-to-Hip Ratio(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Body Fat Percentage(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Periumbilical Subcutaneous Fat Thickness(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Total Cholesterol(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Triglycerides(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in High-Density Lipoprotein Cholesterol(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Low-Density Lipoprotein Cholesterol(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Fasting Plasma Glucose(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Fasting Insulin(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Homeostatic Model Assessment of Insulin Resistance(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Glycated Hemoglobin(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Systolic Blood Pressure(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Diastolic Blood Pressure(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Mean Change From Baseline in Mean Arterial Pressure(Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24)
- Number of Participants With Adverse Events(From the first treatment session at Week 0 up to Week 24)
- Number of Participants With Serious Adverse Events(From the first treatment session at Week 0 up to Week 24)
研究者
Chia-Lin Lin
Attending Physician, Department of Chinese Medicine
Taipei City Hospital