ABSTRACT
[Objective] We performed a multi-center randomized controlled trial using sham acupuncture as a control in the 11 institutions of Aichi and Shizuoka prefecture at which we practice our original acupuncture method. <BR>[Design · Methods] Patients were randomly allocated to four groups : A group, “Taikyoku-Ryoho” (whole body acupuncture method) pole treatment combined with low frequency electroacupuncture; B group, “TaikyokuRyoho” pole treatment; C group, low frequency electroacupuncture; D group, sham acupuncture. Therapeutic effectiveness was evaluated using a visual analogue scale (VAS) and criteria of the Japanese Orthopedic Association for low back pain (JOA score). After these evaluations, patients in B group received low frequency electroacupuncture and patients in C group received “Taikyoku-Ryoho” pole treatment. Patients in D group received both therapies. Thus, all patients eventually received the entire series of therapies. [Results] Significant improvement (P<0.05) in VAS and JOA scores was recognized after one acupuncture treatment in A, B and C groups, but not in D group. There were no differences in terms of the effectiveness among A, B and C groups.<BR>[Conclusion] Our original acupuncture method of “Taikyoku-Ryoho” combined with low frequency electroacupuncture was superior to sham acupuncture. However, the definition of sham acupuncture needs to be more clearly defined in future research.