Oxygen-Ozone Therapy for Herniated Disc: Analysys of Complicances

1. Oxygen-Ozone Therapy for Herniated Disc: Analysys of Complicances G.Pellicanò, M.Bonetti,, M.Leonardi, M.Muto, C.Andreula ITALY

2. In 2004 FIO (Federazione Italiana di Ossigeno-Ozono Terapia) started the study group for eventual adverse reaction during or after oxygen-ozone treatment for herniated disc • Our tool was the FIO website (www.webfio.it), where in a private area all clinical data and eventual adverse reactions and complicances are stored of 26.000 patients

6. NO CASES OF adverse reactions Some vagal crisis NO CASES OF spondylodiscitis. COMPLICATIONS

8. American Journal of Ophtalmology Vol.138,n1 2004

9. A 45-year-old woman was referred to the orthopedics department for an intradiscal (10-ml) and periganglionic (20-ml) injection of O2O3 mixture at an ozone concentration of 27 g/ml for the treatment of lumbar disk hernition. The injections were administered by an extraspinal lateral approach at the L1-L2 level using a 22-gauge 17.78-cm spinal needle. Time for each injection was globally 15 seconds. No premedication or anesthesia was given, and the procedure was performed at an outpatient facility.

10. Immediately after the procedure she noticed “patches” obscuring her vision in both eyes. An ophthalmic examination 7 days after infiltration disclosed a visual acuity of 20/320 OS and 20/40 OD with a massive premacular hemorrhage involving the left macula

11. Drainage of premacular hemorrhage into the vitreal cavity by neodymium:yttrium-aluminum-garnet (Nd:YAG) laser was obtained 3 weeks later in the left eye

12. We consider more likely that an abrupt, transient spike in cerebrospinal fluid pressure after disk infil- tration was responsible for the retinal hemorrhages. We also suggest that an increased intradiscal pressure with an overload and microrupture of the disk after the injection could have caused a quick spread of the mixture into epidural space proportional to thespeed and volume of the infiltration.

13. An increase in cerebrospinal fluid pressure after the injection was thus transmitted directly through the optic nerve sheaths to the retinal venous circulation, thus causing distension and rupture of peripapillary and retinal capillaries.

14. Our considerations • Too much quantity (10cc intradiscal and 20cc periganglionar) • We too experimented the ozone presence in the epidural spaces even if only very few cc • The action mechanism can be accepted but not using our mixture quantity • No informations regarding the procedure guidance. • No correlation between causes and effects

15. A case of Vertebrobasilar Stroke During Oxygen-ozone Therapy F.Corea,S.Amici,N.Murgia,N.Tabasco Journal of Stroke and Cerebrovascular Disease, Vol.13,N.6 Nov-Dec 2004 The patient was admitted from a local pain clinic and developed, during a lumbar (L5-S1) intradiscal ozone injection for sciatica, a tension-type frontal headache without nausea and vomiting and then, almost suddenly, bilateral blindness. At entrance, the oculistic evaluation was negative; the neurologic examination showed right inferior facial nerve palsy, global amnesia, spatial and temporal agitated disorientation, delirium, and bilateral cortical blindness, with sparing of the fotomotor reflex.

16. A case of Vertebrobasilar Stroke During Oxygen-ozone Therapy F.Corea,S.Amici,N.Murgia,N.Tabasco Journal of Stroke and Cerebrovascular Disease, Vol.13,N.6 Nov-Dec 2004 Magnetic resonance images showed hyperintensities in the occipital cortex, and frontal white matter bilaterally and in the left thalamus in the T2-weighted sequences Visual disturbances gradually recovered by the fourth day, making possible a discharge in 10 days.

17. A case of Vertebrobasilar Stroke During Oxygen-ozone Therapy F.Corea,S.Amici,N.Murgia,N.Tabasco Journal of Stroke and Cerebrovascular Disease, Vol.13,N.6 Nov-Dec 2004 Intense painful stimulus during the procedure, which was not image guided, could have provoked paroxystic cardiac arrhythmias leading to embolic migration of thrombotic debris from cardiac chambers. Patients, according to available protocols, receive an intradiscal 4-mL and periganglionic 8-mL injection of an oxygen- ozone mixture at an ozone concentration of 27 g/ml

18. Our considerations • No radiological guidance • We can assume that intense pain can provoke arithmia, but, if our procedure is correct, a so intense pain isn’t present • We don’t undestand if this pain theory is an ipothesis or the patient really suffered for this pain? • CT guidance!!!

19. The patient was a 59-year-old female who had no history of any major disease. She had a typical low back pain Nuclear magnetic resonance (NMR) of the lumbosacral spinal cord (!!!) showed a posterior protrusion of the L4 - L5 disk that contacted the proximal portion of the L5 radicular pouch and a median posterior protrusion of the L5 -S1 disk with moderate bilateral foraminal stenosis.

20. 1 month later, she received a percutaneal intra-discal (L5) injection of an O2O3 mixture with an ozone concentration of 10 g/mL. The patient did not complain of any sensation immediately after introduction of needle and drug, but a few minutes after the procedure, she experienced paresthesia along the anterolateral compartment of the left leg and hypesthesia over the dorsum of the left foot; the day after, lombosciatalgia occurred in left limb. According to clinical, physical, and electrophysiologic findings, ventral and dorsal root injury was diagnosed.

21. The real mechanism underlining this double injury is not clear. • The hypothesis of a direct toxic effect of ozone is unremarkable • Assuming the presence of microfractures of the annulus fibrosus, one possibility is that an abrupt, transient spike in CFP after disk infiltration was responsible for the lesions. • The possibility of direct damage by needle introduction may be clinically excluded because the subject did not complain of electric shock sensation after needle introduction.

22. Ourconsiderations • The concentration (10 µg/ml) is low butwhatabout the quantity and injectionpressure? • Isitcorrecttotreatpatientwith a bulgingwithoutradiculopathy? • Which procedure wasperformed? Whichguidancetype?

23. A 57-year-old man previously treated with oxygen-ozone therapy presented low back and bilateral pain. The lumbar computed tomography revealed the presence of L4 –L5 and L5–S1 herniated discs. Three days after admission in the hospital, the patient developed a fulminant septicemia. An abdominal-pelvic and chest computed tomography and blood culture led to the diagnosis of pyogenic lumbar muscle involvement, accompanied with septic pulmonary embolism secondary to Escherichia coli infection.

24. This case report identifies a rare and fatal complication of oxygen-ozone therapy in the treatment of a herniated lumbar disc. Acute fatal septicemia should be considered among the major complications of the oxygen-ozone therapy in the treatment of a herniated lumbar disc.

25. The most likely pathophysiological mechanism in our case was direct inoculation of the bacteria during the procedure. In our opinion, prophylactic antibiotic therapy should always be given to the patient

26. Our considerations • Paravertebral treatment for sciatalgia? • Which Technique? Concentration Quantity? • Was antibacteric filter used? • Asepsis? • Is antibiotic prophilaxys really needed ?

28. A Metaanalysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar DiscsJim Steppan, PhD, Thomas Meaders, BS, Mario Muto, MD, and Kieran J. Murphy, MD, FRCPC • J Vasc Interv Radiol 2010; 21:534–548

29. MATERIALS AND METHODS • Random-effects metaanalyses were used to estimate outcomes for oxygen/ozone treatment of herniated discs. A literature search provided relevant studies that were weighted by a study quality score. Separate metaanalyses were performed for visual analog scale (VAS), Oswestry Disability Index (ODI), and modified MacNab outcome scales, as well as for complication rate. Institutional review board approval was not required for this retrospective analysis.

30. RESULTS • Metaanalyses were performed on the oxygen/ozone treatment results for almost 8,000 patients from multiple centers. The mean improvement was 3.9 for VAS and 25.7 for ODI. The likelihood of showing improvement on the modified MacNab scale was 79.7%. The means for the VAS and ODI outcomes are well above the minimum clinically important difference and the minimum (significant) detectable change. The likelihood of complications was 0.064%.

31. CONCLUSIONS • Oxygen/ozone treatment of herniated discs is an effective and extremely safe procedure. The estimated improvement in pain and function is impressive in view of the broad inclusion criteria, which included patients ranging in age from 13 to 94 years with all types of disc herniations. Pain and function outcomes are similar to the outcomes for lumbar discs treated with surgical discectomy, but the complication rate is much lower (<0.1%) and the recovery time is significantly shorter.

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