Background/Objectives: Thread-embedding acupuncture (TEA) is widely used for cosmetic and therapeutic purposes; however, its safety profile, particularly in real-world clinical settings, remains under-researched. This study aimed to evaluate the safety profile of TEA through a prospective, observational analysis and confirm the feasibility of the study design for future studies involving larger patient populations. Methods: A multicenter, prospective observational study was conducted involving 100 patients who received TEA. Adverse events (AEs) were tracked, including incidence, severity, and duration during the 6-month post-treatment period. Bivariate analysis was used to assess factors influencing AE occurrence, including treatment site, depth, and patient-specific variables. Results: A total of 100 patients received 136 treatments during the study period. A total of 12 AEs were reported, most of which were mild and transient local reactions, including pain and bruising. More than half of the AEs occurred on the day of the procedure, with an average duration of 7 days. No serious AEs were observed, and all events resolved without any lasting effects. Patients undergoing multiple treatments showed no significantly higher AE rates than those receiving a single session. Conclusions: This study suggested that TEA generally has a favorable safety profile, with most AEs being mild and resolving without long-term effects. Further studies that evaluate the safety of TEA treatment across larger populations are recommended.

Background: The aim of the present study is to confirm the efficacy, safety, and cost-effectiveness of thread-embedding acupuncture (TEA) in the treatment of adhesive capsulitis (AC). Methods: This is a randomized, sham-controlled, patient-assessor blinded trial with two parallel arms in a 1:1 ratio. A total of 160 participants with AC, also known as frozen shoulder, will be recruited and screened according to the eligibility criteria. Those who meet the eligibility criteria will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive either real TEA or thread-removed STEA treatment on nine acupoints once a week for 8 weeks while being blinded to the intervention. The shoulder pain and disability index will be evaluated as a primary outcome measure. In addition, a 100-mm pain visual analogue scale, rotator cuff quality of life scale, European Quality of Life 5-dimension 5-level scale, treatment satisfaction, safety assessment, and economic evaluation will be assessed as secondary outcome measures. Outcome assessments will be conducted for a total of 24 weeks, including a treatment period of 8 weeks and follow-up of 16 weeks, according to the schedule. Discussion: The results of this trial will provide a clinical basis for the efficacy, safety and cost-effectiveness of TEA in the treatment of patients with AC. Trial Registration Number: KCT0005920 (Clinical Research Information Service of the Republic of Korea). Registered on 22 February 2021.

Purpose: This study aimed to evaluate the effectiveness and safety of combination treatment with thread-embedding acupuncture (TEA) and electroacupuncture (EA) in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation. Patients and Methods: Twelve patients with knee osteoarthritis (KOA) who experienced postoperative pain were randomized to either the treatment group (TG) or control group (CG) in a 1:1 ratio. The TG received TEA once a week for four sessions and EA twice a week for eight sessions while continuing usual care, defined as standard conventional treatments. The CG received only usual care for four weeks. The primary outcome was the visual analogue scale (VAS) score at week 4 compared with the baseline. The secondary outcomes were the VAS scores at weeks 2, 6, and 8, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), the EuroQol 5-Dimension 5-Level (EQ-5D-5L), and rescue medication consumption at weeks 2, 4, 6, and 8. Adverse events were assessed at each visit. Results: The TG showed significant improvement in the VAS scores at weeks 4, 6, and 8 compared with the CG (week 4: − 24.5; p = 0.0106, week 6: − 19.667; p = 0.0228, week 8: − 28.667; p = 0.0036). In the TG, significant differences were observed in K-WOMAC total scores at weeks 2, 4, 6, and 8 (week 2: 17.167; p = 0.0083, week 4: 23; p = 0.0018, week 6: 29.833; p = 0.0009, week 8: 30.5; p = 0.0006); however, there were no differences between the two groups. The two groups had no significant differences in the EQ-5D-5L and rescue medication consumption. No adverse events were observed in either groups during the study period. Conclusion: This feasibility study suggests that adding combination treatment with TEA and EA to usual care might relieve pain in patients with KOA. Large-scale clinical trials are needed to confirm the long-term effects of combination treatment.

Background/Objectives: Medical therapies that apply biodegradable materials, such as polydioxanone, are widely used to treat various disorders. Thread-embedding acupuncture (TEA) is a unique form of acupuncture that exerts long-lasting therapeutic effects by inserting absorbable threads at specific acupuncture points, and is widely used to treat various diseases. However, there is currently a lack of research regarding the safety of TEA. This prospective observational trial aims to evaluate the safety of TEA by collecting and analyzing data related to adverse events in patients receiving TEA in actual practice. Methods: A total of 350 eligible participants who undergo TEA at one of three university-affiliated hospitals and two traditional Korean medicine clinics will be systemically observed for post-treatment adverse reactions. The patients will be monitored at three time points: 1 week, 1 month, and 3 months post-treatment. Safety evaluations will assess the incidence of adverse events and treatment discontinuation rates during the 3-month post-treatment period. Conclusions: This study will evaluate the safety of TEA and provide information for decision-making in clinical practice as well as basic data for future large-scale research.

This study aimed to analyze the status of adverse events (AEs) in the treatment of musculoskeletal conditions/ diseases using thread embedding acupuncture (TEA). Five electronic databases were searched to retrieve data on clinical studies published in the last 5 years (2016 to 2021). Of the 151 studies retrieved, 22 studies analyzed AEs and were selected for this review. There were no AEs reported in 6 studies (27.3%); of the remaining 16 studies, 4 studies (18.2%) reported AEs that were not related to TEA. The most common AEs reported in the Chinese studies were redness of skin with/without swelling and tingling sensation, and in the Korean studies they were stiffness, a foreign body sensation, and bruising. The percentage of patients with AE experience was 5.1% in the Chinese studies and 19.9% in the Korean studies. The discrepancies between the findings in the Chinese and Korean studies may be attribute to differences in the diameter of needles, thread materials, TEA treatment procedure, and evaluation methods for AEs. Most of the reported AEs were of a mild status and did not last for a long time. However, further research on the clinical course after TEA treatment is needed.

Jae Yong Lee, Dong Wook Shim, Soo Kwang An, Eun Seok Kim, Byung Ryul Lee, Gi Young Yang. Korean J Acupunct 2021;38:308-16. https://doi.org/10.14406/acu.2021.032