Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

Study Overview
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Brief Summary
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Overweight and obesity are chronic non-communicable diseases with a rapidly increasing global prevalence. They constitute risk factors for various chronic conditions, including cardiovascular diseases, type 2 diabetes, chronic kidney disease, cancer, as well as musculoskeletal disorders and numerous other disorders, significantly impacting the quality of life. Numerous non-pharmacological interventions have been employed in the management of these conditions. Particularly, Auricular acupuncture (AA) has been a widely used and established method for weight management, owing to its effectiveness, safety, and convenience. Recently, a novel therapy known as Thread embedding acupuncture (TEA) has also demonstrated efficacy in weight reduction. Several studies have shown a substantial increase in treatment effectiveness when combining TEA with other acupuncture therapies. However, there is currently no available data on the combination of TEA with AA. This study is conducted to assess the efficacy and safety of combining TEA with AA compared with AA monotherapy in overweight and obesity.

Detailed Description
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Eligible participants with overweight or obesity, defined according to the criteria set by The World Health Organization Regional Office for the Western Pacific Region (Body Mass Index [BMI] of 23 kg/m² or higher), will be enrolled and subsequently randomized into two groups: the intervention group (AA + TEA group) and the placebo group (AA + Sham-TEA group), with a 1:1 allocation ratio. In both groups, the intervention duration is eight weeks, with Auricular acupuncture (AA) administered weekly, along with recommended lifestyle modifications. For the intervention group, Thread embedding acupuncture (TEA) therapy will be added every two weeks, totaling four sessions during the eight-week period. Meanwhile, Sham-TEA will be administered in the placebo group. Data regarding body weight, BMI, waist circumference, hip circumference, appetite, and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

Official Title
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Efficacy and Safety of Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity: Randomized Placebo-Controlled Trial

Conditions
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Overweight or Obesity

Intervention / Treatment
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* Other: Auricular acupuncture
* Other: Thread embedding acupuncture
* Other: Sham Thread embedding acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Simple overweight or obesity with a Body Mass Index (BMI) of 23 kg/m2 or higher, following the criteria of The World Health Organization Regional Office for the Western Pacific Region. Waist circumference of 90 cm or more for males, or 80 cm or more for females. Voluntary informed consent. Exclusion Criteria: Secondary obesity resulting from endocrine diseases or medication. Presence of severe medical conditions (e.g., cardiovascular, hepatic, renal or others) that could potentially affect treatment outcomes as per researchers' assessments. Current use of weight-affecting medications, including diabetes medications, endocrine medications, and medications for neurological psychiatric disorders. Pregnancy, lactation, or recent childbirth within the past 6 months. Severe mental and neurological conditions that may impact treatment compliance. Alcohol or substance addiction. History of hypersensitivity reactions to any form of acupuncture with needles or to Polydioxanone. Existing injuries or lesions at the acupoints under investigation in this study. Concurrent participation in other clinical trials or utilization of other weight reduction therapies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AA + TEA<br>Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Thread embedding acupuncture (TEA) every two weeks in eight weeks (four sessions). | Other: Auricular acupuncture<br>* Auricular acupuncture is conducted weekly in eight weeks using patches, each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. Five acupoints on one ear are selected, which included Shen-men (TF4), Stomach (CO4), Spleen (CO13), Endocrine (CO18), and Hunger point. The patch with the needle will remain in place for one week.<br>Other: Thread embedding acupuncture<br>* Thread embedding acupuncture is performed every two weeks in eight weeks using a single Polydioxaone thread. Needles has a gauge size of 29G, a shaft length of 38mm, and a thread length of 50mm, folded in half, and are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles with a gauge size of 30G, a shaft length of 25mm, and a thread length of 30mm, folded in half, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.<br>|
| Sham Comparator: AA + Sham-TEA<br>Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Sham Thread embedding acupuncture (Sham-TEA) every two weeks in eight weeks (four sessions). | Other: Auricular acupuncture<br>* Auricular acupuncture is conducted weekly in eight weeks using patches, each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. Five acupoints on one ear are selected, which included Shen-men (TF4), Stomach (CO4), Spleen (CO13), Endocrine (CO18), and Hunger point. The patch with the needle will remain in place for one week.<br>Other: Sham Thread embedding acupuncture<br>* Sham Thread embedding acupuncture is performed every two weeks in eight weeks. Needles without threads has a gauge size of 29G, and a shaft length of 38mm, are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles without threads with a gauge size of 30G, and a shaft length of 25mm, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the needle being inserted into the body, it will be withdrawn immediately.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | The body weight of the participants will be collected by investigators in the morning after the participants' personal hygiene routine and before breakfast, with measurements in kilograms (kg). | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Mass Index (BMI) | BMI will be calculated with the Quetelet index formula, with units in kg/m². | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Changes in waist circumference | The waist circumference of the participants will be measured by investigators in the morning after the participants' personal hygiene routine and before breakfast, with units in centimeters (cm). The waist circumference measurements will be conducted in accordance with the protocol established by the World Health Organization. | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Changes in hip circumference | The hip circumference of the participants will be measured by investigators in the morning after the participants' personal hygiene routine and before breakfast, with units in centimeters (cm). The hip circumference measurements will be conducted in accordance with the protocol established by the World Health Organization. | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Changes in waist-hip ratio | The waist-hip ratio will be calculated by dividing the waist circumference(cm) by the hip circumference(cm). | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Changes in the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score | The FCQ-T-r consists of 15 items. Participants will be requested to express their agreement using a Likert-type scale that ranges from 1 = strongly disagree to 5 = strongly agree, allowing for total scores within the range of 15 to 75, with higher scores indicating greater appetite. | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Changes in Visual Analog Scale (VAS) score for appetite | The VAS consists of a 100mm long line with two endpoints, ranging from no appetite to greatest appetite ever experienced. Participants will mark the position on the scale that corresponds to their current appetite sensation. | Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8) | 
| Proportion of intervention-related adverse effects | Expected adverse events (AEs) for Auricular acupuncture include pain at the insertion site, local discomfort, local skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. For Thread embedding acupuncture, expected AEs encompass local discomfort, post-treatment elevation in body temperature, local hematoma or subcutaneous hemorrhage, local swelling, local induration, local pain, local redness, infection, abscess, pruritus, and anaphylaxis. Additionally, any unexpected AEs associated with these procedures will also be documented and monitored. | Up to eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, auricular acupuncture, thread embedding acupuncture, traditional medicine