Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial

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 2weeks for 8weeks (four sessions in total), while the acupuncture group received acupuncture twice per week for 8weeks (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 10weeks after treatment initiation (the 10-week assessment was conducted at 2weeks 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 8weeks 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.