Thread Embedding Acupuncture Therapy for Weight Loss
ConditionObesity and Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Hospital of Traditional Chinese Medicine
About this trial
Obesity is the most prevalent chronic disease worldwide, affecting approximately 800 million adults. Excess adiposity and its numerous complications, including cardiovascular disease and type 2 diabetes, impose a considerable economic burden and constitute major contributors to global morbidity and mortality. Treatments that result in substantial weight reductions may improve outcomes for people living with obesity. Thread embedding acupuncture which provides long-term acupoints stimulation may be an effective treatment option for obesity. However, effects of thread embedding on obesity remain uncertain because of the small sample sizes or other methodological limitations. The objective of this multi-center, randomized, sham-controlled trial is to assess the effect of thread embedding acupuncture for alleviating weight.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;
Male or female, age between 18 and 75 years at the time of signing informed consent;
No history of receiving thread embedding treatment;
History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
Disqualifiers
A self-reported change in body weight ≥ 5 kg within 90 days before screening;
Treatment with any medication for the indication of obesity within the past 90 days before Screening;
Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening; (2) lap banding, if the band had been removed more than 1 year before screening; (3) intragastric balloon, if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 year before screening;
Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);
Trial design
Design model
Parallel
Treatments tested in this trial
Thread embedding acupuncture
Other interventionThread embedding acupuncture is performed using polyglycolic acido thread. Needles have a gauge size of 23G, a shaft length of 60mm, and a thread length of 50mm, folded in half, and are applied to fourteen acupoints, including Zhongwan (CV12), Qihai (CV6), bilateral Tianshu (ST 25), bilateral Wailing (ST 26), bilateral Daheng (SP 15), bilateral Zusanli (ST 36), bilateral Pishu (BL 20), and bilateral Weishu (BL 21). After the thread is inserted into the body, the needle will be withdrawn immediately. During the treatment period, health counseling will be provided by qualified staff at every visit, including diet and physical activity, but there will be no strict restrictions.
Sham thread embedding acupuncture
Other interventionThe protocol includes the same duration and frequency of sessions as for thread embedding acupuncture, but the treatment will be delivered superficially at non-acupuncture points 10mm from the lateral of the corresponding acupuncture and not above a meridian line. Needles without threads have a gauge size of 23G, and a shaft length of 60mm will be used. After the needle is inserted into the body, it will be withdrawn immediately. During the treatment period, health counseling will be provided by qualified staff at every visit, including diet and physical activity, but there will be no strict restrictions.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Thread embedding acupunctureExperimental treatment 1 intervention
Group B: Sham thread embedding acupunctureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Relative change in body weight
Measured in percentage (%)
Time frame
From baseline (week 0) to end of treatment (week 24)Secondary outcomes
1
Body weight reduction greater than or equal to 5%
Measured as the percentage of participants
Time frame
From baseline (week 0) to end of treatment (week 24)2
Body weight reduction greater than or equal to 10%
Measured as the percentage of participants
Time frame
From baseline (week 0) to end of treatment (week 24)3
Change in body weight
Measured in kilogram (kg)
Time frame
From baseline (week 0) to end of treatment (week 24)4
Change in Body Mass Index (BMI)
Measured in kilogram per square meter (kg/m\^2)
Time frame
From baseline (week 0) to end of treatment (week 24)Sponsors and contacts
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Source ClinicalTrials.gov