• Hyun-Jong Lee, Byung Il Choi, Seungah Jun, Mu Seob Park, Se Jung Oh, Jung Hee Lee, Han Mi Gong, Jae Soo Kim, Young Joon Lee, So-Young Jung, and Chang Hyun Han.
• Department of Acupuncture and Moxibustion medicine, College of Korean Medicine, Daegu Haany University, Daegu, 42158, Republic of Korea.
• Trials. 2018 Dec 12; 19 (1): 680.

BackgroundWe investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale randomized controlled trial on this topic.MethodsForty participants were recruited for this two-arm, assessor-blinded randomized controlled pilot trial. The participants were randomly allocated to a TEA group (experimental group) or an acupuncture group (control group). The TEA group received TEA once every 2 weeks for 8 weeks (four sessions in total), while the acupuncture group received acupuncture twice per week for 8 weeks (16 sessions in total). The primary outcome was the visual analog scale (VAS) score for pain and the secondary outcomes were short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry Disability Index (ODI) scores. Assessments were performed at screening and at 2, 4, 6, 8, and 10 weeks after treatment initiation (the 10-week assessment was conducted at 2 weeks after treatment cessation).ResultsOf the 40 participants, 36 completed the study and four dropped out. Both the TEA group and the acupuncture group showed significant improvements in VAS, SF-MPQ, and ODI scores in a time-dependent manner. Furthermore, with regard to ODI, a significant interaction between group and time was observed, with the two groups exhibiting a different pattern of change at 8 weeks according to contrast analysis with Bonferroni's correction. No serious adverse event occurred, and hematological and biochemical test findings were within normal limits.ConclusionThis pilot study has provided basic data for a larger clinical trial to demonstrate the efficacy and safety of TEA for chronic LBP.Trial RegistrationClinical Research Information Service of the Korea National Institute of Health, ID: KCT0001819 . Registered on 15 February 2016.

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