Effect of Acupoint Thread Embedding on Obesity

The Effect and Safety of Acupoint Thread Embedding on Over-weight and Obesity Treatment : A Randomized, Single-Blind, Sham- Controlled Study

The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: acupoint thread embedding

Detailed Description

Obesity refers to a complex chronic disease in which there is excessive accumulation of body fat. As of 2016, there were more than 650 million obese people worldwide, and it is expected to reach 1.12 billion by 2030, with at least 2.8 million deaths due to obesity each year, according to surveys. In Europe, 60 percent of the population is already overweight or obese. The incidence of obesity is also increasing rapidly in China, with a recent report by The Lancet showing that the number of obese people in China has reached 85 million, making it the country with the highest number of obese people in the world. In 2002, the China Obesity Task Force recommended threshold value to define overweight as Body Mass Index (BMI) of ≥ 24 kg/m2, a waist circumference (WC) ≥of 85 cm for men and a WC ≥ 80 cm for women, or a Waist-to-Hip Ratio (WHR) of ≥ 0.9 for men and a WHR ≥ 0.8 for women, and to define obesity as a BMI ≥ 28 kg/m2. Studies have shown that Asian populations have higher health risks at the same BMI and WC levels due to the distribution of adipose tissue. Acupoint thread embedding is a widely recognized therapy to lose weight in clinical practice.But there are some doubts about the effectiveness of acupoint thread embedding versus sham acupoint thread embedding in treating obesity due to its lack of medical evidence.

This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of acupoint thread embedding (ATE) in obese patients. The investigators designed a protocol for a randomized controlled trial, in which 110 eligible patients will be randomly assigned to one of the two groups: the ATE group (receiving ATE treatment with health education) and the sham acupoint thread embedding (SATE) group (receiving SATE treatment with health education). A total of 6 sessions of interventions will be given for consecutive 12 weeks, followed by 12 weeks follow-up period. Each session of ATE or SATE treatment will last for about 30 minutes. The primary outcome is the change of the body mass index (BMI) at week 12. The secondary outcomes include the change of patient's body weight and body circumference, results from the blood tests (FBG, LDL-C, HDL-C, TG and TC), the abdominal visceral fat tissue thickness scanned by abdominal B-ultrasound, data collected from the body composition analyzer, the and scores of the impact of weight on quality of life (IWQOL-Lite), the well-being index (WHO-5), visual analog scale (VAS) of appetite and hamilton anxiety scale(HAMA). All adverse effects will be accessed by the treatment emergent symptom scale (TESS) from baseline to the follow-up period. The body weight and circumferences and BMI will be calculated at baseline, week 6, week 12, and week 24. The IWQOL-Lite, WHO-5, VAS, the HAMA, blood tests and abdominal B-ultrasound will be calculated at baseline and week 12. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-week intervention period.

All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary outcome is the change of the body mass index (BMI) at week 12. Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V.20.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity, as well as determine the differences between the ATE and SATE treatment.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Recruiting
      • Shanghai Municipal Hospital of Traditional Chinese Medicine
      • Contact: Shifen Xu, PhD; Phone Number: +8613761931393; Email: xu_teacher2006@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females aged 18~45 years old;
• BMI≥24.0 kg/m2；
• WC≥80cm ; recommended BMI and WC threshold value to define overweight in China;
• Stable weight change (increase or decrease of ≤4 kg) within 3 months prior to the start of the test;
• Agree to participate in the trial and sign a written informed consent form;

Exclusion Criteria:

• Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);
• History of bariatric surgery (gastric reduction, liposuction, etc.);
• Are taking medications that may affect the results of the trial (weight):
• Severe ulcers, abscesses, skin infections, etc. at the acupuncture site;
• Severe heart, brain, lung, liver and kidney insufficiency, hematopoietic system disease or other serious diseases;
• Participated in other clinical medical trial studies in the past 1 month;
• History of acupoint thread embedding in the past 6 months;
• Alcoholism, drug abuse, or smoking (change in smoking habits within the past 2 months or a plan to quit smoking during the study period);
• Pregnant and lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupoint Thread Embedding group+health education; Acupuncture thread embedding (ATE), extension and development of acupuncture therapy, which emerged in mid 1950s, is an acupoint stimulation technique which sterile biodegradable threads (such as polydioxanone (PDO) threads) are inserted into acupuncture points, by using hollow core embedding needles. The aim of this therapy is provide long term stimulation of acupoints, making this technique one of the most commonly used methods for treating obesity.	Other: acupoint thread embedding; Acupoint embedding therapy:Main acupoints: Shangguan (CV-13), Xiaguan (CV-10), Tianshu (ST-25), Daheng (SP-15), Fenglong (ST-40), Qihai (CV-6), Zhongguan (CV-12), Zusanli (ST-36), Quchi (LI-11), Guanyuan (CV-4), Wailing (ST-26), Daju (ST-27), Shuidao (ST-28), Daimai (GB-26), Liangmen (ST-21), Ashi acupoints , where local fat accumulation in the abdomen. Methods of operation: With the patient in the prone position and all acupoints routinely sterilized, the acupuncturist will use sterile forceps to insert a 3-0 × 2-cm poly-p-dimethyl-hydroxy-oxazolone (PDO) thread into the tip of the #6 (0.6 mm × 60 mm) disposable embedded thread needle. The tissue around the area of the acupuncture point will be lifted with the thumb and forefinger of the non-dominant hand and the needle will be inserted into the acupuncture point to a depth of 1.5 cm with the dominant hand. Each treatment will last maximum of 10 minutes and the intervention will be repeated every 2 weeks for a total of 6 sessions.; Other Names: sham acupoint thread embedding
Sham Comparator: Sham Acupoint Thread Embedding group+health education; Sham acupoint thread embedding method in this study is set as the Sham acupoint thread embedding manipulated at the same main acupoints won't be put into trocar and de qi sensation will not be obtained. The aim of the sham acupoint thread embedding is to eliminate the possible placebo effect of ATE treatment.	Other: acupoint thread embedding; Acupoint embedding therapy:Main acupoints: Shangguan (CV-13), Xiaguan (CV-10), Tianshu (ST-25), Daheng (SP-15), Fenglong (ST-40), Qihai (CV-6), Zhongguan (CV-12), Zusanli (ST-36), Quchi (LI-11), Guanyuan (CV-4), Wailing (ST-26), Daju (ST-27), Shuidao (ST-28), Daimai (GB-26), Liangmen (ST-21), Ashi acupoints , where local fat accumulation in the abdomen. Methods of operation: With the patient in the prone position and all acupoints routinely sterilized, the acupuncturist will use sterile forceps to insert a 3-0 × 2-cm poly-p-dimethyl-hydroxy-oxazolone (PDO) thread into the tip of the #6 (0.6 mm × 60 mm) disposable embedded thread needle. The tissue around the area of the acupuncture point will be lifted with the thumb and forefinger of the non-dominant hand and the needle will be inserted into the acupuncture point to a depth of 1.5 cm with the dominant hand. Each treatment will last maximum of 10 minutes and the intervention will be repeated every 2 weeks for a total of 6 sessions.; Other Names: sham acupoint thread embedding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	one of the criteria for evaluating the body weight and health status of a person. BMI = weight (kg)/height (m)2. Each subject will be provided with a free Bluetooth Internet-enabled scale to monitor their weight at regular intervals, and the researcher will be able to access the data from the backend	week0, week6, week12, week24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	The change in body weight at the end of the intervention compared to the baseline.	week0, week6, week12, week24
Changes in body circumference	Waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), waist-height ratio (WHtR), and the average value of the changes in each circumference at the end of the intervention were calculated compared with the baseline. WHR=WC/HC; WHtR=WC/height .	week0, week6, week12, week24
Body composition analysis	Evaluating changes in body fat percentage or composition by using bioelectrical impedance analysis (BIA) device (InBody770; Biospace, Seoul, Korea)., which allows for high-density body composition measurements, including muscle mass, body water content, body fat percentage, visceral fat grade, and other body components, by bioelectrical impedance analysis.	week0, week6, week12, week24
Abdominal visceral fat tissue thickness	Abdominal B-ultrasound scanning of the upper abdomen and flat umbilicus level will be used to quantitatively calculate the visceral fat thickness.	week0, week12
Fasting blood glucose (FPG)	glucose concentration in the blood in the early morning fasting, which can reflect the function of pancreatic β-cells,HOMA-IR, Insulin level.	week0, week12
Blood lipid profile	including Low-density Lipoprotein (LDL), High density lipoprotein (HDL), triglyceride (TG), cholesterol (TC), reflects the lipid metabolism within the body.	week0, week12
Impact of Weight on Quality-of-Life Scale (IWQOL-Lite)	a 31-item self-report scale consisting of a total score and individual scores on 5 dimensions, i.e., physical functioning, self-esteem, sexuality, public stress, and work, to assess the quality of life of obese patients	week0, week12
Well-Being Index (WHO-5)	shot, self-administered subjective measure of well-being over the last two weeks. It consists of 5 positively worded item that is rated on 0-6 which is 0 means at no time and 5 is all the time.	week0, week12
Visual analog scale (VAS) of appetite	This method relies on a line segment of 100 mm or 150mm in length, with the two ends pointing to "I have no appetite at all" and "I have a very good appetite" respectively. Subjects mark the line according to their level of appetite. The patient was determined to have a reduced appetite if the measured line segment was <50 mm or 70 mm.	week0, week12
Hamilton Anxiety Scale (HAMA)	The CCMD-3 Chinese Diagnostic Criteria for Mental Disorders lists it as an important diagnostic tool for anxiety disorders, and is often used clinically as the basis for the diagnosis and degree classification of anxiety disorders. The total score can better reflect the severity of anxiety symptoms, and can be used to evaluate the severity of anxiety symptoms in patients with anxiety and depressive disorders and evaluate the effects of various drugs and psychological interventions. According to the information provided by the Chinese scale collaboration group: the total score is ≥ 29 points, which may be severe anxiety; ≥ 21 points, there must be significant anxiety; ≥ 14 points, there is definitely anxiety; More than 7 points, there may be anxiety; If the score is less than 7, there are no anxiety symptoms.	week0, week12
Adverse effects	Any adverse event (described as unfavourable or unintended signs, symptoms or diseases occurring during the trial) related to the intervention will be reported by patients and practitioners and accessed by the Treatment Emergent Symptom Scale (TESS) which is used as an associated indicator to mainly evaluate the safety of acupoint thread embedding treatment in this trial.	week6, week12, week24

Collaborators and Investigators

• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Randomized Controlled Trial; Acupoint Thread Embedding; Sham Acupoint Thread Embedding
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: XSF20240312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
• IPD Sharing Time Frame: All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
• IPD Sharing Access Criteria: The data in this trial will be publicly available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No