Effect of Acupoint Thread Embedding on Obesity

NCT ID: NCT06316310

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-12-31

Brief Summary

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.

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 132 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 FibroScan, data collected from the body composition analyzer, and the 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，BMI，IWQOL-Lite, WHO-5, VAS, and the HAMA, will be calculated at baseline, week 6, week 12, and week 24. blood tests，FibroScan and the body composition analyzer's data will be calculated at baseline，week 12 and week24. 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.29.0. 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.

Conditions

Obesity

Keywords

Acupoint Thread Embedding; Sham Acupoint Thread Embedding; Obesity; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

acupoint thread embedding

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

acupoint thread embedding

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

sham acupoint thread embedding

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shifen Xu, PhD

Role: primary

Other Identifiers

XSF20240312

Identifier Type: -

Identifier Source: org_study_id