Award Papers / Dr Kop's Award
Efficacy of Pregabalin alone and in Combination with Pulsed Radiofrequency lesioning of Intercostal Nerves for the Management of Postherpetic Neuralgia: A Randomized, Double-blind Controlled Study
University College of Medical Sciences (University of Delhi) & GTB Hospital
SahuAjitesh, Saxena Ashok Kumar, LakshmanKavitha, Banerjee BD, SingalArchana
(a)To evaluate the efficacy of Pulsed Radiofrequency lesioning of Intercostal nerves for the management of Postherpetic neuralgia (PHN). (b)Modulation of mRNA expression of IL-6, IL-10,TNFa & NGF gene (c)Evaluation of QOL
METHODS :In this prospective, randomized, double-blind controlled study, following IEC approval and written informed consent, 54 patients of PHN were categorised in a randomized fashion into two groups of 27 each: Study group PP (Pregabalin + PRF Lesioning) & Control group SP (Pregabalin + Sham lesioning). Cap Pregabalin 75mg BID was prescribed for 12 weeks in both the groups. PRF lesioning (50000 Hz) of Intercostal nerves was done for 240 secs under C-arm fluoroscopy using radiocontrast dye. Various parameters (as for pain, Interleukins & QOL are mentioned in results) were recorded at baseline, just prior to lesioning, at the end of 1st, 2nd, 4th, 6th, 8th and 12th week following PRF lesioning. Results were analysed using SPSS software (version 20.0) involving repeated measure ANOVA followed by Tukey’s test. Power of the study was 96%.
RESULTS :Significant reduction in mean VAS scores, NPSI scores relevant to burning, squeezing, stabbing, tingling, pins & needle, pressure & electric shock like sensation, and significant improvement of GPE scores were observed at end of 1st, 2nd , 4th, 6th, 8th and 12th week following multimodal approach in study group. Also similar improvements seen in NRS Sleep scores and Physical & Mental component of SF-12 QOL at different intervals in study group. The mRNA expression of IL-6 and TNFα gene were significantly downregulated and that IL-10 was significantly upregulated at the end of 8thweek post PRF lesioning.
CONCLUSIONS :This prospective, randomized, double-blind, controlled study in PHN patients found significant evidence of benefit on measures of pain (VAS, NPSI, GPE, NRS Sleep), Quality of life (QOL) and significant downregulation of mRNA expression of IL-6 and TNFα gene &upregulation of IL-10 gene following the integrated approach utilizing PRF lesioining and Pregabalin. It is advisable to undertake a large prospective RCT on evaluation of this integrated multimodal approach on a multicentric basis