A Prospective Multicenter Randomized Study On The Combined Treatment Of Cold-Dampness Type Chronic Non-Specific Low Back Pain With "Wood Lock Medicated Balm + Multifunctional Physiotherapy Instrument"

BackgroundLow back pain(LBP)is a common and frequent disease,and is the ninth most burdensome disease among all ages in the world in 2020,among which non-specific low back pain(NLBP)accounts for 85%of the patients with clinical low back pain,and its treatment is also a worldwide problem.Because of the high popularity and acceptance of traditional Chinese medicine,it can provide a simple,convenient,inexpensive and effective treatment method for patients with chronic non-specific low back pain(CNLBP)and reduce the side effects of long-term medication,so it has attracted much attention.Previous studies have shown that comprehensive treatment methods are more effective than single treatment for CNLBP,and with the modern"medical-industrial combination",a"medicine+mechanical"treatment model with TCM characteristics,combining allopathic Chinese medicine and modern rehabilitation equipment,is conducive to standardized and unified treatment.The combination of allopathic Chinese medicine and modern rehabilitation equipment is conducive to standardization and unification of treatment standards,and can give better play to the therapeutic effects of Chinese medicine.Therefore,it is of good practical significance to evaluate the therapeutic effect of the"medicine+mechanics"treatment plan on cold-dampness CNLBP through clinical trials.ObjectiveCNLBP is a common and frequent clinical disease,and the cold-dampness type is the main TCM type,and the relevant clinical guidelines and expert consensus recommend TCM as an adjunctive treatment.In this study,we aimed to observe the efficacy of the combined treatment of"wood lock medicated balm+multifunctional physiotherapy instrument"on cold-dampness CNLBP,with the aim of forming a set of effective standardized physiotherapy solutions and providing data to support the clinical application of this therapy.MethodsA prospective multicenter randomized controlled clinical trial was conducted from January 2022 to December 2022 by the relevant departments of the First Affiliated Hospital of Naval Military Medical University,the Southern Theater Air Force Hospital,and the Second Guangdong Provincial Hospital of Traditional Chinese Medicine,aged 18to 40 years,with visual analogue scale(VAS)pain scores of 3 to 7 and cold-dampness type TCM evidence scale score>14.The subjects were divided in a 1:1 ratio into a control group receiving conventional treatment and an observation group treated with the combination of"wood lock medicated balm+multi-functional physiotherapy Instrument",and were managed in a"randomized center"manner.The control group was given diclofenac sodium extended-release tablets orally,100mg/day,and capsaicin plaster externally,2 patches/day,for 7 days.The observation group received two sessions of cupping and scraping based on wood lock medicated balm(50ml,Wong To Yick?,Hongkong,China)on the 1st and 4th days of their involvement in this trial.The area of scraping was taken between Dazhui(GV 14)and Baihuanshu(BL 13)on the back of the subject,between 3 cun on either side of the posterior median line.For cupping,the waist and local acupoints of the subjects were selected,including Shenshu(BL 23),Dachangshu(BL 25),Pangguangshu(BL 28)and Weizhong(BL 40)on both sides.The primary outcome was evaluated by VAS scale.There were two secondary outcomes.First,the Japanese orthopaedic association scale(JOA)was used to evaluate the low back pain,including subjective symptoms,clinical signs,limits of daily activities and bladder function.The second is the evaluation of cold-dampness TCM syndrome score scale.A score of more than 14 points can be diagnosed as cold-dampness syndrome low back pain,and the higher the score,the more severe the cold-dampness syndrome.The above scales were scored on the first day(A~0)before treatment,the fourth day(A~1)and the seventh day(A~2)after treatment.The therapeutic effect of cold-dampness type CNLBP was observed according to the changes of the scores.Total effective rate of each scale(%)=cure rate+significant efficiency rate+effective rate.ResultsA total of 156 subjects were included in this study,26 cases dropped out,and 130cases were finally analyzed,including 68 cases in the observation group and 62 cases in the control group.There were no significant differences in baseline data before treatment between the two groups(P>0.05).The scores of VAS scale,cold-dampness TCM syndrome score scale and JOA scale of the two groups before and after treatment were significantly improved,and the differences were statistically significant(P<0.001).(2)Based on the VAS scale score,before treatment,the score of the observation group was(4.93±0.68),and the score of the control group was(4.94±0.74),there was no statistically significant difference between the two groups(P>0.05).After treatment,the score was(2.26±0.94)in the observation group and(3.03±0.96)in the control group,and the difference was statistically significant(P<0.001).Linear regression analysis showed that the difference between the two methods and the scores at A~0-A~1(P=0.001)and A~0-A~2(P<0.001)was statistically significant.The effective rate was 94.1%in the observation group and 82.3%in the control group,and the difference was statistically significant(P<0.001).(3)Based on the cold-dampness TCM syndrome score scale,before treatment,the scores of the observation group and the control group were(20.34±4.94)and(21.26±5.15),respectively,and there was no statistically significant difference between the two groups(P>0.05).After treatment,the score was(9.82±3.71)in the observation group and(14.39±4.28)in the control group,and the difference was statistically significant(P<0.001);Linear regression analysis showed that the difference between the two methods and the scores at A~0-A~1(P<0.001)and A~0-A~2(P<0.001),the difference was statistically significant.The total effective rate was 89.7%in the observation group and53.2%in the control group,and the difference was statistically significant(P<0.001).(4)Based on JOA scale,before treatment,the scores of observation group and control group were(21.87±3.75)and(20.61±3.91),respectively,and the difference was not statistically significant(P>0.05).After treatment,the score was(26.62±1.21)in the observation group and(24.76±1.91)in the control group,and the difference was statistically significant(P<0.001);Linear regression analysis showed that the difference between the two methods and the scores at A~0-A~1was statistically significant(P<0.01),while the difference between the scores at A~0-A~2was not statistically significant(P>0.05).The effective rate of the observation group was 97.1%,and that of the control group was 74.2%,the difference was statistically significant(P<0.001).ConclusionThe combination of cupping and scraping therapy with"wood lock medicated balm+multifunctional physiotherapy instrument"in the observation group and oral diclofenac sodium extended-release tablets with capsaicin plaster in the control group were effective in treating cold-dampness type CNLBP,and both methods significantly reduced the VAS scale score,improved the TCM score of cold-dampness symptoms,and improved limb mobility.The treatment effect of the observation group was better than that of the control group in terms of the degree of improvement and overall efficiency.It was confirmed that the"medicine+mechanics"mode of Chinese traditional medicine is an effective treatment plan for cold-dampness type CNLBP.It is more advantageous to treat CNLBP with different types of evidence-based treatment,and can be applied in clinical practice.