| Objective:We conducted this clinical randomized controlled trial to investigate the intervention effect of the comprehensive moxibustion of the fire dragon cup on postpartum body pain with cold-dampness obstruction syndrome,to provide new technologies and methods for clinical nursing of postpartum body pain,and to provide reference for further clinical application for fire dragon cup.Methods:This study adopted a single-blind,single-center,clinical randomized controlled trial design.From September 2021 to December 2021,subjects were screened in the gynecological clinic and rheumatology clinic of Liaoning Traditional Chinese Medicine Affiliated Hospital in Shenyang,Liaoning Province,and the patients with postpartum body pain who met the criteria for admission and discharge were divided into the experimental group and the experimental group according to the random number table.The control group and the experimental group were given comprehensive moxibustion with fire dragon cup,the control group was given a placebo(imitation pot)for intervention,and both the test group and the control group were given routine nursing care.The intervention plan was formulated according to the operating norms formulated by the Nursing Committee of the Liaoning provincial Association of Traditional Chinese Medicine;the first 3 times of the two groups were intervened once a day,the 4th and 5th times were intervened once every other day,and the latter 3 times were intervened once every 2 days.Interventions were performed for 30-40 min each time,with a total of 8 times within an whole intervention cycle,15 days as an whole intervention cycle.Patients were cared for during the procedure,and subjects were followed up 30 days after the intervention.The visual analogue scale(VAS score)was used as the primary outcome index,the TCM syndrome score and total effective response were used as the secondary outcome indexes,and the incidence of adverse reactions was used as the safety evaluation index.Basic information such as age,pregnancy,parity,etc.of the patients were collected.The visual analog score and TCM syndrome score were recorded before the intervention,15 days after the intervention and 30 days after the intervention,and the curative effect of the intervention was statistically compared.Statistical Analysis: the data were analyzed by SPSS 25.0 software,and the measurement data were tested by T test or rank sum test,repeated measure data were analyzed by repeated measure variance.P < 0.05,the difference was statistically significant.Results:1.a total of 76 patients were included in this study,38 in the trial group and 38 in the control group.There was no significant difference between the two groups in terms of age,pregnancy times,birth times,course of disease,mode of delivery,treatment history,disease location,Vas score and TCM syndrome score(P > 0.05),the two groups are comparable in equilibrium.2.Efficacy evaluation results:2.1 Main outcome indicators-VAS score results: Compared with the VAS scores of the subjects in the two groups at the baseline and the 15 th day of the intervention,the scores of the 15 th day of the intervention were lower,and the P values were all less than 0.01.There was no significant difference in the VAS scores of the experimental group on the 15 th day of intervention and 30 days after the intervention(P>0.05).The difference was statistically significant(P<0.01).The VAS scores of the 15 th day after intervention and 30 days after the end of the intervention were compared between the control group and the experimental group.The scores of the experimental group were lower than those of the control group,and the difference was statistically significant(P<0.01).2.2 Secondary outcome indicators-TCM syndrome score results: Compared with the TCM syndrome scores of the two groups at the baseline and the 15-day intervention,the scores on the 15-day intervention were lower,and the P values were all less than 0.01.There was no significant difference in the TCM syndrome scores of the experimental group after 15 days of intervention and 30 days after the intervention(P>0.05).The score at 30 days increased,and the difference was statistically significant(P<0.01).The scores of TCM syndromes on the 15 th day of intervention and 30 days after the end of the intervention were compared between the control group and the experimental group. Secondary outcome indicators-total effective rate: 38 cases in the experimental group with 20 cases(52.63%)were markedly effective,11 cases(28.94%)were effective,and 7cases(18.42%)were ineffective,with a total effective rate of 81.57%.38 cases in the control group with 14 cases(36.84%)were effective,24 cases(63.16%)were ineffective,and the total effective rate was 36.84%.Comparing the two groups,the total effective rate of the experimental group was higher than that of the control group,and the difference was statistically significant(P<0.01).3.Safety evaluation results: There were no adverse reactions in both the experimental group and the control group during the test.Conclusion:Comprehensive moxibustion with fire dragon pot can effectively reduce the pain symptoms of postpartum body pain patients with cold-dampness obstruction syndrome,reduce the TCM syndrome score,improve the total effective rate of treatment and the curative effect has a certain persistence.The recurrence rate of the disease is low,safe and reliable,and suitable for clinical application and promotion. |
