Objective To evaluate the efficacy and safety of bone trauma spray (containing musk, dragon’s blood, rhubarb, borneol, cinnabar, toads, alcohol and others) on acute and chronic soft tissue pain.Methods From January 2011 to December 2013, 157 out-patients with acute and chronic soft tissue pain were divided into two groups according to the different treatments. 62 patients in the control group used oxycodone hydrochloride orally. 95 patients in the study group used oxycodone hydrochloride orally and bone trauma spray. Analgesia onset time, improvement of symptoms. Before and after treatment, and pain VAS scores were Compared between the two groups. And the safety of drug on patients after treatment was checked.Results Three patients in the study group had local skin allergic reactions, the trial was so put an end. In the study group, VAS pain score was significantly lower than that in the control group(P<0.01). Pain, swelling, local tenderness, aggravation with cold relief after treatment in the study group, compared with the control group, were significantly different(P<0.05). The effective rate in the study group was 92.39%, significantly higher than that (80.65%) in the control group (P<0.05). Analgesia onset time in the study group was significantly shorter than in the control group(P<0.01), and did not find heart, liver, kidney or other organ damages.Conclusions TCM external medicine bone trauma spray for treatment of acute and chronic pain is effective and has no significant side effects.