CT Guided Ozonotherapy with Foraminal Approach for Cervical Herniated Discs:6 Months Follow- Up of 50 Patients Vyletelka J., Labaj V.: Department of Neurology, Žilina,Slovakia FIO 2007,Bologna, oct.2007 Kongres Talianskej Spoločnosti pre Ozonoterapiu

Patients and methods - jan 2006 – mar patients 27 men 23 women -age 29 – 69 years, mean age 47,7 years - all patients provided informed consent

Patients and methods /cont./ Inclusion criteria: Clinical: -cervical pain resistant for conservative management /drugs, physiotherapy,bed rest/ -lasting at least 6 weeks -neurological signs of nerve root involvement Neuroradiologic: CT and/or MR evidence of cervical disc herniation /corresponding with patient´s clinical symptoms/ with or without disc degeneration

Patients and methods /cont./ Exclusion criteria: Patients- with major neurologic deficit - with EMG features of neurogenic injury and /or denervation - free fragments of herniated disc

Patients and methods /cont./ Method of aplication: foraminal under CT guidance Procedure: Desinfection of injection site Local anesthesia using an ethyl chloride spray 22-gauge needle / Terumo /, 9 cm Mixture O2-O3 konc.27ug/ml, volume 2 ml to neural foramen 2 ml to facet joint region Equipment- ozone generator Alnitec,Cremosano,Italy – allowing the pho- tometric detection of the concentration of O3 in the gas mix- ture,constant pressure during the O3-intake operation

CT guided foraminal approach

Patients and methods /cont./ Follow-up: -after 2 weeks, months -outcomes of treatment were classified using : McGill Pain Questionnaire modified McNab method

Outcomes evaluations Visual Analog Scale / VAS /

Outcomes evaluations Modified version of McNab method: 1.excellent – complete resolution of pain and return to activity before 2.good/satisfactory – reduction of pain by 50% and more 3.mediocre/poor – partial reduction of pain by 30% or less 4.worsening

Results Disc treated 1.C 3/4 1 patients 2.C 4/5 1 patients 3.C 5/6 25 patients 4.C 6/7 25 patients

Results Number of procedures: -1x procedure 39 patients -2x procedure 10 patients -3x procedure 1 patients

Results Modified version of McNab method: 1.excellent 23 / 46 % / patients 2.good/satisfactory 18 / 36 % / patients 3.mediocre/poor 7 / 14 % / patients 4.worsening 2 / 4 % / patients Surgery 5 / 10 % / patients 3 pt no improvement 2 pt improved 3. months excellent – good/satisfactory 85,00% 6. months 82,00% 82%

Results McGill Pain Questionnaire – Visual Analog Scale / VAS / -before treatment 6,22 points -after treatment 2,64 points change 3,58 points Statistically evaluated with test : t-test Interval reliability for mean values /Confidence interval/ Value of VAS schould be in interval reliability for mean values (3,56; 4,35) in 95% probability

Results Employment after tretment: 1.employed 40 patients / 80 % / 2.no employed 10 patients / 20 % / 5 / 10%/ pat pensioned 5 / 10%/ pat disabled

Complications -no early or late neurological complications -no infections -pain in root distribution by injection of mixtrure O2O3 -vegetative symtoms / vertigo,dizzines,nausea,vomitting / -5 / 10% / of patients

Conclusion Results : 1.VAS - change 3,58 / interval reliability / 3,56 – 4,35 / statist.signif 2.modified McNab Sc. - excellent / good results 82,0 % This study confirm original results of italian ozonotherapists and their recommendations that oxygen-ozone therapy schould be the first option to treat cervical disk herniation that has failed to respond to conservative management, before recourse to surgery or when surgery is not possible.