OBJECTIVE: To evaluate the effect of hand-ear acupuncture on chronic low-back pain(cLBP).METHODS: This was an open, randomized and controlled trial in The General Hospital of Western Theater Command, Sichuan Province. The trial was registered with ClinicalTrials.gov, NCT02260284. All the 152 participates with cLBP were randomly assigned to hand-ear acupuncture(n = 54), standard acupuncture(n = 50), or usual care groups(n = 48).Eighteen treatments were provided over 7 weeks.Back-related dysfunction and symptom severity were assessed by the Roland-Morris Disability Questionnaire(RMDQ) and the Visual Analogue Scale(VAS), which were collected at baseline, 2 months and 6 months post to the treatment.RESULTS: At 6 months, the RMDQ scores improved by 7.74 points of hand-ear acupuncture group. Significant improvement of VAS and RMDQ was observed in hand-ear acupuncture group(P < 0.001),but no significant changes of RMDQ were observed in both standard acupuncture group and usual care group. We also observed an overall efficacy rate of 88.89% in hand-ear acupuncture group, as evaluated by Diagnosis and Curative Effect Standard for Symptom pattern of Traditional Chinese Medicine, which was much higher than 45.84% in the usual care group(H = 16.000, P < 0.001).CONCLUSION: Both of the hand-ear acupuncture and standard acupuncture modes have beneficial and persistent effectiveness against cLBP compared with the usual care. Furthermore, hand-ear acupuncture is significantly more effective than the standardized acupuncture, especially in the long term.