To observe the impact of indirect moxibustion with Taiyi moxa stick on pain severity and the quality of life in the patients with back myofascitis, and evaluate its clinical effect and safety. Seventy-two patients with back myofascitis were randomly divided into an observation group (36 cases, 1 cases dropped out) and a control group (36 cases, 3 cases dropped out). Three to six ashi points were selected using acupoint diagnosis methods. In the observation group, the indirect moxibustion with Taiyi moxa stick was operated at the ashi points, once every other day, three times a week. In the control group, the topical treatment with diclofenac sodium gel was given at ashi points, three times daily. The treatment was delivered consecutively for 2 weeks in the two groups. The scores of visual analogue scale (VAS) and the short-form McGill pain questionnaire (SF-MPQ) were recorded before treatment, after 1 and 2 weeks of treatment, and after 4 weeks of treatment completion (follow-up visit) in the two groups separately. The difference value between VAS score after 2 weeks of treatment and that before treatment was taken as the primary outcome. The SF-36 score was observed before treatment, after 2 weeks of treatment and during the follow-up visit, and the safety was evaluated in the two groups. The difference value of VAS scores was (-4.57±1.50) points and (-2.40±1.31) points in the observation group and the control group, respectively, the reduction of the score in the observation treatment was larger than that of the control group (P<0.001). After 1 and 2 weeks of treatment and during the follow-up visit, VAS and SF-MPQ scores were reduced when compared with those before treatment (P<0.05) in the two groups, and VAS and SF-MPQ scores in the observation group were lower than those in the control group (P<0.05). In the follow-up visit, VAS and SF-MPQ scores in the observation group were dropped in comparison with those after 1 week of treatment (P<0.05), and these scores in the control group were elevated compared with those after 2 weeks of treatment (P < 0.05). After 2 weeks of treatment and during the follow-up visit, the score of each dimension and total score of SF-36 scale were increased in comparison with those before treatment in the observation group (P<0.05); and the scores of the dimensions except that of mental health of SF-36 scale were elevated in the control group (P<0.05). During the follow-up visit, in the control group, the scores of physical functioning, bodily pain, general health and role emotional were elevated when compared with those before treatment (P<0.05). After 2 weeks of treatment and during the follow-up visit, the score of every dimension and total score of SF-36 scale in the observation group were higher than those in the control group (P<0.05). During the follow-up visit, the score of bodily pain was increased when compared with that after 2 weeks of treatment in the observation group (P<0.05), while the scores of bodily pain and vitality were dropped in the control group (P<0.05). No adverse event happened in the two groups. The indirect moxibustion with Taiyi moxa stick effectively reduces pain severity and improves the quality of life in the patients with back myofascitis. This therapy presents the superior and persistent effect compared with topical application of diclofenac sodium gel.
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