| Background and purposesTrigeminal neuralgia(TN)defines clusters of recurrent,paroxysmal,sudden,severe,unilateral and transient facial pain induced by slight facial stimulation.So far medication and neurosurgical treatment are still the two mainstream treatments for TN regardless of a great number of inevitable side effects and severe surgical complications among these treatments.Recently many clinical evidences and cases both from domestic research and overseas have suggested that botulinum neurotoxin-A(BoNT-A)is an effective and safe treatment for TN.It’s commonly asserted that 1ml syringe is a standard in the treatment of TN by BoNT-A,whereas there is discrepancy between the point of injection depth.Featured with consistency of depth and dose of each point and plus bloodless,multi needle current has been widely used in facial medical cosmetology.But there are no evidences or trials in terms of the therapeutic application of multi needle in TN.Regarding to analysis of curative effect,operational convenience and patient comfort,we applied multi needle to treat the individuals with classical trigeminal neuralgia(CTN)in comparison with ordinary needle according to BoNT-A treatment protocol in this study.MethodsAll included patients with CTN who meet all criteria from score guide were recruited from the first affiliated Hospital of Zhengzhou University from April 2020 to December 2020.Signature on informed consent was confirmed from each patient.During BoNT-A injection,the ordinary group used 1ml ordinary syringe,and another group used multi needle.The characteristics of injection including times,points,pain and the number of swabs consumed were recorded.The pain intensity,attack frequency and adverse reactions were followed up every week until 12 weeks after treatment.Visual analog scale(VAS)was used to evaluate the pain intensity.Patients with VAS reduction of greater than or equal to 50%were considered as"effective".The patient global impression of change(PGIC)score was performed at the 12 weeks after treatment.Statistics and analysis of two groups of VAS changes,efficiency,PGIC score,safety,injection process differences at endpoint.ResultsIn this study,30 cases in the ordinary group and 30 cases in the multi needle group were treated respectively.There was no statistical difference in basic prior treatment condition between the two groups.1 Efficacy of 60 patientsThe main VAS scores of the 60 patients at the 1w,2w,3w,4w,8w and 12w after treatment were decreased compared with that before the treatment,both had statistically significant(P<0.001).At the 12w after treatment,there were 53 patients indicated that their VAS decreased by more than 50%,so the effective rate was 88.53%,and 35 cases stated that their pain was completely controlled.The PGIC was performed at the 12w after treatment,there were 52 cases(86.67%)reported that their pain symptoms were‘very significantly improved’ or‘significantly improved’.2 Comparison of the two groups2.1 Comparison of the efficacy between the two groupsThe VAS scores of the ordinary group and the multi needle group at the 1w,2w,3w,4w,8w and 12w after treatment compared with those before the treatment,both had statistically significant(P<0.001).But at all the same time after treatment,there was no significant difference in the VAS between the two groups(P>0.05).At the 12w after treatment,the effective rate of the ordinary group was 90%(27/30),and the multi needle group was 86.67%(26/30),there was no significant difference(P>0.05).The PGIC was evaluated at the 12w after treatment,90%(27/30)of the patients in the ordinary group reported that their pain symptoms were ’very significantly improved’ and ’significantly improved’,and the multi needle group was 83.33%(25/30),there was no significant difference(P>0.05).2.2 Comparison of operational convenience and patient comfort between the twogroupsThe number of operations in the multi needle group was 5.12±0.36,which was less than that in the ordinary group(15.45±1.09),P<0.001.The number of treatment sites of each branch in the multi needle group was 25.58±1.82,which was more than that in the ordinary group(15.45±1.09),P<0.001.VAS was also used to evaluate the pain of patients during injection,and the score of multi needle group was 4.83±0.70,which was lower than that of ordinary group(6.57±0.73),P<0.001.The amount of bleeding in the process of injection was indicated by the number of swabs consumption,the number of multi needle group was 1.73±0.79,which was less than that in the ordinary group(3.47±1.04),P<0.001.Conclusions1.BoNT-A is an effective treatment for classical trigeminal neuralgia.2.Ordinary needle and multi needle were similar in efficacy in short-term.3.In the process of injection,the operational convenience and degree of patient comfort from multi needle is better than the ordinary needle. |
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