Trampling With Halluces Manipulation Combined With Sacral Canal Injection On The Treatment Of Lumbar Intervertebral Disc Prolapse:a Multi-Center Randomized Controlled Trial

Objective:This research was a multi-center randomized controlled trail of tramp ling with halluces manipulation which is used to treat protrusion of the lumbar intervertebral disc(LDP) paired with sacral canal injection. In order to get the clinical efficacy, the change of Lumbar activity function, Visual Analogue Scale(VAS) of leg pains and waist pains, lumbar lordosis in this trail was observed,and we provide high-quality clinical evidence in the LDP treatment.Methods:The subjects came from.4clinical center,including the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Sichuan Provincial People’s Hospital, Sichuan orthopedics hospital,and Dayi County Hospital of traditional Chinese medicine.In this trail,198patients of LDP were randomly assigned to two groups using central randomization,the patients were randomly divided into tramp ling with halluces manipulation combined with sacral canal injection group (Treatment group)and electroacupuncture combined with traction and massage therapy group(Control group).Treatment group received trampling with halluces manipulation combined with sacral canal injection, tramp ling with halluces manipulation daily1time,each time for20min,6times after the treatment rest1day.Sacral canal injection1time a week,for4weeks.Control group was given electroacupuncture combined with traction and massage, electroacupuncture daily1time,6times after the treatment rest1day. massage therapy daily1time after traction treatment,6times after the treatment rest1 day.Massage20min each time,1time a day,6times after the treatment rest1day.Two groups of treatment period was4weeks,follow-up at Twelfth weeks after the end of treatment. At baseline and after4weeks of treatment and12weeks after treatment was the evaluate time point.The function of lumbocrural pain score, Visual Analogue Scale(VAS) of leg pains and waist pains, lumbar lordosis were used to assess the patients before and after treatment and follow-up.Results:1.Baseline Analysis:(1)The compared baseline of Sociodemographic basic characteristics,indicators of all the patients were consistent with good comparability when they entered their groups respectively(P>0.05)(gender,age,marital status,height,weight,body mass index,work time,work type of baseline);(2)The compared baseline of clinical features indicators of all the patients were consistent with good comparability when they entered their groups respectively(P>0.05)(differentsegments, direction,);(3) The compared baseline of severity’s indicators of all the patients were consistent with good comparability when they entered their groups respectively(P>0.05)(The function of lumbocrural pain score, Visual Analogue Scale(VAS) of leg pains and waist pains,lumbar lordosis)2.Efficacy Evaluation:(1)after4weeks of treatment, two groups of patients with The function of lumbocrural pain score.back muscle strength, range of motion and activities were significantly higher than those before treatment(P<0.01),statistically significant differences between two groups(P<0.05).(2)after4weeks of treatment,two groups of leg pain VAS visual analog scores were significantly lower than before treatment(P<0.01),statistically significant differences between two group s(P<0.05).(3)after4weeks of treatment two groups of waist pain visual analog score of VAS were significantly lower than those before treatment(P<0.01),statistically significantdifferences between two groups(P<0.05).(4) lumbar lordosis of the two groups improved significantly after4weeks(P<0.01),statistically significant differences between two groups(P<0.05).3.Safety Assessment:Two groups of adverse events occurred in1cases,respectively.chest tightness after sacral canal injection and bleeding after the needle.the incidence of adverse events was1%and1.06%respectively. The two groups the incidence of adverse eventscompared with no difference(p>0.05).Conclusions:1.two groups have the same effect in treatment of LDP, treatment regimen is safe and effective.2. In improvement of leg pain and back pain, Control group may be better.3.1n the improvement of lumbar lordosis, Treatment group maybe better.