Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Recruiting

CT.gov ID

NCT06091761

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight or Obesity	Other: Auricular acupuncture Other: Thread embedding acupuncture Other: Sham Thread embedding acupuncture	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants will be unaware of their random allocation into either the intervention or placebo group. Sham Thread embedding acupuncture (Sham-TEA) will be administered in a manner similar to TEA, but without the insertion of threads, ensuring that no threads are left at the acupoints after the procedure. The physician responsible for administering the treatments will be aware of the group assignments but remain uninvolved in the evaluation of outcomes and subsequent data analysis. Those responsible for outcome assessment and data analysis will be kept blinded to the treatment assignments.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AA + TEA 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 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. Other: Thread embedding acupuncture 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.
Sham Comparator: AA + Sham-TEA 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 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. Other: Sham Thread embedding acupuncture 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.

Arm

Intervention/Treatment

Experimental: AA + TEA

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

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.

Other: Thread embedding acupuncture

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.

Sham Comparator: AA + Sham-TEA

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

Other: Sham Thread embedding acupuncture

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.

Outcome Measures

Primary Outcome Measures

Changes in body weight [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)]
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).

Secondary Outcome Measures

Changes in Body Mass Index (BMI) [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)]
BMI will be calculated with the Quetelet index formula, with units in kg/m².
Changes in waist circumference [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)]
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.
Changes in hip circumference [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)]
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.
Changes in waist-hip ratio [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)]
The waist-hip ratio will be calculated by dividing the waist circumference(cm) by the hip circumference(cm).
Changes in the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score [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)]
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.
Changes in Visual Analog Scale (VAS) score for 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)]
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.
Proportion of intervention-related adverse effects [Up to eight weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.