太乙神针治疗背肌筋膜炎的临床疗效:随机对照试验

Clinical effect of indirect moxibustion with Taiyi moxa stick in treatment of back myofascitis:a randomized controlled trial

目的:观察太乙神针治疗对背肌筋膜炎患者疼痛程度和生活质量的影响,评价其临床疗效和安全性。方法:将72例背肌筋膜炎患者随机分为观察组(36例,脱落1例)和对照组(36例,脱落3例)。首先通过腧穴诊察方法选取背部3~6个阿是穴,观察组于阿是穴处行太乙神针治疗,隔日1次,每周治疗3次;对照组于阿是穴涂抹双氯芬酸钠凝胶治疗,每日用药3次。两组均连续治疗2周。于治疗前、治疗1、2周后和治疗结束后4周随访,观察两组患者视觉模拟量表(VAS)评分、简化McGill疼痛问卷(SF-MPQ)评分,以治疗2周后与治疗前VAS评分差值作为主要结局指标;于治疗前、治疗2周后与随访时,观察两组患者健康调查简表(SF-36)评分,并观察两组安全性。结果:观察组和对照组VAS评分差值分别为(-4.57±1.50)分、(-2.40±1.31)分,观察组降低幅度大于对照组(P<0.001)。治疗1、2周后和随访时,两组患者VAS、SF-MPQ评分较治疗前降低(P<0.05),观察组患者VAS、SF-MPQ评分均低于对照组(P<0.05);随访时,观察组患者VAS、SF-MPQ评分较治疗1周后降低(P<0.05),对照组患者VAS、SF-MPQ评分较治疗2周后升高(P<0.05)。治疗2周后和随访时,观察组患者SF-36各维度评分及总分较治疗前升高(P<0.05);治疗2周后除精神健康维度外,对照组患者其余维度SF-36评分及总分较治疗前升高(P<0.05),随访时,对照组生理职能、躯体疼痛、总体健康、情感职能维度SF-36评分及总分较治疗前升高(P<0.05);治疗2周后和随访时,观察组患者SF-36各维度评分及总分均高于对照组(P<0.05);随访时,观察组患者躯体疼痛维度评分较治疗2周后升高(P<0.05),对照组躯体疼痛、精力维度评分较治疗2周后降低(P<0.05)。两组患者均未发生不良事件。结论:太乙神针能有效改善背肌筋膜炎患者的疼痛程度,提高其生活质量,疗效优于双氯芬酸钠凝胶外用且较持久。

Objective 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.Methods 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.Results 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.Conclusion 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.