Abstract： Objective： To observe the clinical effect of needle knife regulating spinal zone for primary insomnia. Methods： A total of 122 cases of patients with primary insomnia were randomly divided into the needle knife group， the genuine acupuncture group， and the placebo- acupuncture group， 40， 41 and 41 cases in each group respectively. The needle knife group was treated with needle knife regulating spinal zone，the genuine acupuncture group was given routine acupuncture，and the placebo-acupuncture group was given placebo-acupuncture. Before and after treatment，the changes in the scores of Pittsburgh Sleep Quality Index(PSQI)，Self-Rating Anxiety Scale(SAS) and Beck Depression Inventory(BDI)， the total sleeping time and the sleep latency， as well as the clinical effect were evaluated. Results： The comparison of PSQI，SAS and BDI before and after treatment between the needle knife group and the genuine acupuncture group showed significance in the difference(P＜0.05). The comparison of SAS and BDI before and after treatment in the placeboacupuncture group showed significance in the difference(P＜0.05)，and the comparison of PSQI showed no significance in the difference(P＞0.05). After treatment，the comparison of PSQI in the placebo-acupuncture group showed significance in the difference(P＜0.05)，and the comparison of SAS and BDI showed no significance in the difference(P＞0.05). The comparison of PSQI between the needle knife group and the genuine acupuncture group， between the needle knife group and the placebo- acupuncture group，and between the genuine acupuncture group and the placebo- acupuncture group all showed significance in differences(P＜0.0167). The comparison of the sleep latency and the total sleeping time before and after treatment between the needle knife group and the genuine acupuncture group showed significance in differences(P＜0.05). The comparison of the sleep latency before and after treatment in the placebo-acupuncture group showed significance in the difference(P＜0.05)，and the comparison of the total sleeping time before and after treatment showed no significance in the difference(P＞0.05). After treatment， the comparison of the sleep latency and the total sleeping time among three groups showed significance in differences(P＜0.05). The comparison of the sleep latency and the total sleeping time between the needle knife group and the placebo- acupuncture group， and between the genuine acupuncture group and the placeboacupuncture group showed significance in differences(P＜0.016 7). The evaluation of the clinical effect by PSQI showed that the curative effect in the needle knife group was better than that in the other two groups(Z=53.78， P=0.001<0.05). Conclusion：The application of needle knife regulating spinal zone for primary insomnia is safe and effective.