CT Guided Ozonotherapy with Foraminal Approachfor Cervical Herniated Discs:6 Months Follow- Up

of 50 Patients

Vyletelka J., Labaj V.: Department of Neurology, Žilina,Slovakia

FIO 2007,Bologna, 12.-13.oct.2007

Kongres Talianskej Spoločnosti pre Ozonoterapiu

Patients and methods

- jan 2006 – mar 2007

- 50 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, 3 - 6 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

0

5

10

15

20

25

C3/4 C4/5 C5/6 C6/7

Treated discs

Results

Number of procedures:

-1x procedure 39 patients

-2x procedure 10 patients

-3x procedure 1 patients

0

5

10

15

20

25

30

35

40

1x 2x 3x

Number of aplications

Results

Modified version of McNab method:

1.excellent 23 / 46 % / patients2.good/satisfactory 18 / 36 % / patients3.mediocre/poor 7 / 14 % / patients4.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.