NCT06653530

Thread Embedding Acupuncture Therapy for Weight Loss

Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The present multi-center, randomized, sham-controlled, parallel-group trial aims to evaluate the effect of thread embedding acupuncture in patients with obesity. The patients will be randomized to receive one of two treatment arms: thread embedding acupuncture and sham thread embedding acupuncture. The participants will receive treatment that consists of 18 thread embedding acupuncture or sham thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks). At the end of 24 weeks treatment, the change of weight in overweight/obese participants between the two groups will be analyzed.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
OTHER	Thread embedding acupuncture	Thread 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.
OTHER	Sham thread embedding acupuncture	The 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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-10-22
• Last updated: 2025-01-16

Locations

1 site across 1 country: China