Research On The Safety And Effectiveness Of Domestic Spinal Cord Stimulation Based On The Theory Of "pain Syndrome" In Traditional Chinese Medicine

Background:The rise of Spinal Cord Stimulation(SCS)technology in the 1960s has been widely used in the treatment of a variety of diseases represented by chronic intractable pain.However,currently,there is no independently developed SCS stimulation system in China,and the equipment used is imported and expensive,which limits the popularization and application of this therapy.In order to break the technological monopoly of foreign technology on SCS and improve the application level of SCS treatment in China,the research group cooperated with the neuromodulation laboratory of Tsinghua University and Beijing PINS medical equipment co.,LTD in the early stage to independently develop implantable SCS devices(including stimulating leads,pulse generators,extended wires,and program controllers).Objective:To verify the biosecurity,system stability,operation operability,histocompatibility and stimulation effectiveness of the equipment system,and to provide an entry point for the guidance of integrated traditional Chinese and western medicine in the treatment of SCS.Methods:This study included animal study and clinical study.(1)Animal study:SCS implantation was performed on small tailed han sheep to verify the performance of percutaneous leads,paddle leads and pulse generator in different stimulation modes(low frequency and 10kHz high frequency modes).The behavioral changes,leucocyte levels and equipment impedance values of the animals were observed after the operation,and the spinal cord specimens were taken for HE staining at 1 month after the operation.In this way,the effects of SCS stimulation on sensorimotor function infection status and spinal cord structure of experimental animals were verified,and the device connection stability was verified.(2)Clinical study:patients with chronic intractable pain were included and treated with SCS device(percutaneous lead)implantation(in traditional low frequency mode).Patients succeeded in trial were subsequently implanted with pulse generators;Visual analogue scale(VAS),36-Item Short-Form Health Survey(SF-36),Short-form McGill Pain Questionnaire-2(SF-MPQ-2),Athens insomnia scale(AIS),Beck depression inventory(BDI)were evaluated on baseline,14 days,1 month and 3 months after the surgery,in order to observe the effects of SCS equipment on pain severity,the quality of life,sleep and psychological status;At the same time,when the patients were enrolled,they were classified according to the theory of syndrome differentiation,which was classified as "pain derives from obstruction "and "pain derives from sufficiency",then the SCS effective rates of patients with different syndromes were compared in trial period and 3 months after the operation.Results:(1)Animal study:the movement and sensory functions of experimental sheep were normal within 1 month after the operation,the postoperative WBC level fluctuated within the normal range,the intraoperative and postoperative impedance values were normal,and the equipments were running normally.After 1 month of treatment,there was no obvious lead migration.The HE staining results indicated that,compared with the unstimulated segment,the spinal cord structure in the stimulated segment was normal,with no obvious pathological changes such as cell necrosis,edema,ischemia,and inflammation.(2)Clinical study:a total of 11 patients with chronic intractable pain were included in the study,including 5 males and 6 females,with an average age of 57.33 and an average disease course of 5.18 years.VAS score was 8.12±0.32,4.06±0.79.3.59±0.77,and 4.22±0.86 on the baseline,14 days,1 month and 3 months after the treatment,respectively.VAS score after the treatment significantly decreased compared with baseline(P<0.05).The effective rate was 81.8%(9/11).3 months after the surgery,the "body pain"(BP)dimension of SF-36,SF-MPQ-2 and AIS scores were significantly improved compared with baseline(P<0.05).Other dimensions of SF-36 and BDI scores were improved compared with those before treatment,but no statistical differences were observed.Among the 11 patients,2 patients were "pain derives from sufficiency”type(group A),and 9 patients were "pain derives from obstruction" type(group B).During the trial,the effective rate of group A was 0,and that of group B was 100%.At 3 months,the effective rate of group B was 66.7%and no statistical difference was found between the two groups.The equipments were well connected during the clinical study,and no adverse events were reportedConclusion:(1)The new implantable SCS system.including percutaneous lead and paddle lead,can realize both the traditional low-frequency stimulation mode and the new high-frequency(10kHz)stimulation mode.The optimized lead anchoring device can fix the lead better and avoid the lead migration.Besides,it has good biological safety,histocompatibility and operability.The device is in good condition and stable function,which can meet the needs of clinical application.(2)The new implantable SCS system has significant clinical efficacy and excellent safety.Under standard operation,SCS devices can significantly improve the pain degree,quality of life,sleep quality and psychological status of patients with chronic intractable pain.In this study,the concept of "pain syndrome" of traditional Chinese medicine(TCM)was introduced into the treatment of SCS for the first time,and it was found that the TCM syndrome type had a certain correlation with the clinical efficacy of SCS,suggesting the possibility of the theory of integrated traditional Chinese and western medicine based on the theory of "pain syndrome" participating in the treatment of SCS.