• Purumea Jun, Chang-Hyun Han, Chang Sop Yang, Min Ji Kim, Jae Soo Kim, Cho In Lee, Jung Hee Lee, Chung A Park, Young Joon Lee, and Hyun-Jong Lee.
• Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
• Medicine (Baltimore). 2020 Sep 4; 99 (36): e21957.

IntroductionAlthough there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients.Methods And AnalysisThis study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment.ConclusionThe trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis.Trial Registration NumberKCT0004844.

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