The following is a selection of rigorous, peer-reviewed papers describing the research that has been done on ozone as it applies to the spine. Minimus Spine believes that these data support further development of ozone for disc herniations. Abstracts for these papers can be located on Medline using the links provided.
These papers did not utilize the Minimus Spine system. The company has developed proprietary methods to create and deliver ozone gas to the spine. Minimus Spine believes that these methods represent significant improvements on the systems used in these reports, specifically in the areas of sterility assurance and dose assurance.
Minimus Spine consistently monitors the peer-reviewed literature for new reports on the use of ozone to treat spinal conditions. Please let us know if you come across something that we have missed.
All of this research was performed outside of the United States. At this time, ozone is not FDA approved for medical use in the United States. We are working to bring this technology to patients in the U.S.
Animal Studies
Tian JL, Zhang JS, Xiao YY, Liu JT, Yang B, Li JK, Yu M. Changes of CSF and spinal pathomorphology after high-concentration ozone injection into the subarachnoid space: an experimental study in pigs. Am J Neuroradiol 2007; 28: 1051-54.
Description
An animal study injecting high concentrations of ozone into the spinal canal of pigs. The authors reported no signs of toxicity or neurological injury.
Fuccio C et al. A single subcutaneous injection of ozone prevents allodynia and decreases the over-expression of pro-inflammatory caspases in the orbito-frontal corex of neuropathic mice. Eur J Pharmacol 2009; 601(1-3): 42-49.
Description
An animal study whereby a nerve root injury was created and then followed with a single subcutaneous injection of ozone. Authors reported that ozone was responsible for decreases in inflammatory mediators in the brain and improvements in expressed pain.
Chang JDS, Lu HS, Chang YF, Wang D. Ameliorative effect on ozone on cytokine production in mice injected with human rheumatoid arthritis synovial fibroblast cells. Rheumatol Int 2005:26:141-151.
Description
An animal study evaluating the effect of ozone at various concentrations and nitrogen (serving as a control) on inflammatory cytokines expressed by cultured fibroblasts. Treatment with ozone 3% and 5% reduced the expression of inflammatory cytokines without toxicity or serious side effects.
Clinical Studies
Gallucci M, Limbucci N, Zugaro L, Barile A, Stavroulis E, Ricci A, Galzio R, Masiocchi C. Sciatica: Treatment with intradiscal and intraformainal injections of steroid and oxygen-ozone versus steroid only. Radiology 2007; 242: 907-913.
Description
A blinded randomized trial of 159 patients receiving either steroids or steroid in combination with intradiscal ozone. Patients were followed for 6 months. Those treated with ozone had significantly better results than those treated with just steroids.
Buric J, Molino Lova R. Ozone chemonucleolysis in non-contained lumbar disc herniations: a pilot study with 12 months follow-up. Acta Neurochir Suppl. 2005;92:93-7.
Description
A study of 30 patients with non-contained disc herniation that were treated with intradiscal ozone injection and followed for one year. Ninety percent of patients reported significant improvements in pain and function.
Muto M, Andreula C, Leonardi M. Treatment of herniated lumbar disc by intradiscal and intraforaminal oxygen-ozone (O2-O3) injection. J Neuroradiol. 2004 Jun;31(3):183-9.
Description
Authors report their experience in treating 2,200 patients with various spine pathologies with spinal injections of ozone. Treatment found to be most effective for disc herniation, followed by degenerative disc disease. Patients with stenosis or failed back syndrome had little benefit.
Paradiso R, Alexandre A. The different outcomes of patients with disc herniation treated either by microdiscectomy, or by intradiscal ozone injection. Acta Neurochir Suppl. 2005;92:139-42.
Description
Authors retrospectively identified two demographically matched groups, each containing 150 patients, treated with either surgical discectomy or intradiscal ozone injection. The investigators concluded that both groups demonstrated significant improvements and stated that surgical discectomy is preferred in cases with migrated fragments whereas ozone is preferred in cases without migrated fragments.
Pauloni M, DiSante L, Cacchio A, Apuzzo D, Marotta S, Razzano M, Franzini M, Santilli V. Intramuscular oxygen-ozone therapy in the treatment of acute back pain with lumbar disc herniation. A multicenter, randomized, double blind, clinical trial of active and simulated lumbar paravertebral injection. Spine 2009; 34(13): 1337-1344.
Description
A randomized, double blinded trial of 60 patients receiving a series of either paravertebral injections of ozone or a sham injection. Patients were followed for 6 months. Patients receiving ozone had significantly lower pain scores throughout follow-up and almost twice as many were pain free at six months. This study did not involve intradiscal injections.
Bo W, Longyi C, Jian T, Guangfu H, Hailong F, Weidong L, Haibin T. A pyogenic discitis at C3-C4 with associated ventral epidural abscess involving C1-C4 after intradiscal oxygen-ozone chemonucleolysis. A case report. Spine 2009; 34(8): E298-E304.
Description
A case report of an infection by S. Bovis following an ozone injection in the cervical spine. Authors highlight the need to pay attention to sterility during these procedures.
Gazzeri R, Galarza M, Neroni M, Esposito S, Alfieri A. Fulminating septicemia secondary to oxygen-ozone therapy in lumbar disc herniation. Case report. Spine 2007; 12(3): E121-E123.
Description
A case report of an infection of E. Coli following an ozone injection, highlighting the importance of sterility during these procedures.
Lo Guidice G, Valdi F, Gismondi M, Prosdocimo G, de Belvis V. Oxygen-ozone therapy for lumbar disk herniation. Am J Ophthalmology 2004: 138(1): 175-177.
Description
A case report of a patient receiving an unusually large a volume of gas resulting in temporary loss of vision when the gas migrated up the spinal canal. This case highlights the need for a controlled, limited volume of gas.
