Intraforaminal ozone therapy and particular side effects: preliminary results and early warning

Vanni D, Galzio R, Kazakova A, Pantalone A, et al. Acta Neurochirurgica, 2016.

View the abstract on PubMed

Study type
Case series
People studied
186 people
Population
186 patients (97 men, 89 women, mean age 59.8) having microsurgery for lumbar disc hernia or segmental stenosis; 23 had prior intraforaminal ozone, 28 intraforaminal steroids
Published
2016, Acta Neurochirurgica
Identifiers
PMID 26293228, DOI 10.1007/s00701-015-2545-y
Group
Safety and adverse events

What the authors reported

During lumbar microsurgery in 186 patients, surgeons found hard adhesions between soft tissues and bone, with the nerve root contracted and firmly adherent to the dural sac or disc fragments, only in the group previously given intraforaminal ozone (23 patients, treated elsewhere 12 to 24 months earlier). Patients with no injections or with intraforaminal steroids showed no such abnormalities.

What limits this result

Surgical series reported as preliminary results, read from the abstract only. The abstract does not give the size of the no-injection group, how many of the 23 ozone-treated patients had adhesions, whether the surgeons knew each patient's treatment history, or the ozone concentration and volume used.

Harms reported after ozone therapy, and studies of how ozone exposure affects health. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.

How the study was done

Design
Series of patients who underwent lumbar microsurgery since 2013, compared by prior intraforaminal treatmentSince 2013, 186 patients (97 males and 89 females, mean age 59.8 years) have undergone microsurgery for lumbar disc hernia or lumbar segmental stenosis.
Setting
Orthopaedic and Traumatology Department and Vertebral Surgery Department, G. d'Annunzio University, ASL 2 Lanciano Vasto, Chieti, Italy (first-listed affiliation)
Read from
Read from the abstract only; where this page says nothing about an item, the abstract does not report it. Read on October 2, 2026.

Source: Abstract on PubMed

Study arms

Each group as the paper describes it.
GroupParticipantsWhat they received
All patients having microsurgery since 2013186Microsurgery for lumbar disc hernia or lumbar segmental stenosis
Previously treated with intraforaminal ozone23Ozone therapy by the intraforaminal approach in other hospitals, 12 to 24 months before evaluation
Previously treated with intraforaminal steroids28Intraforaminal steroid injections in other hospitals, 12 to 24 months before evaluation

Source: Abstract on PubMed

Procedure as reported

Sessions
16 applications in an 8-week period ('standard therapy'), stated for 'these patients' without separating the ozone and steroid groups

In the paper's own units, not converted.

Source: Abstract on PubMed

What it measured

Findings during surgery
Many hard adhesions between the soft tissues and bony structures, unexpectedly discovered
Nerve root
Root contracted, with firm adhesions to the dural sac and/or fragmented disc that were difficult to resolve
Patients showing these patterns
Only patients who received ozone injections by the intraforaminal approach
Patients with no injections or with intraforaminal steroid injections
No pathological abnormalities foundWe did not find any pathological abnormalities in the patients who did not receive any injections or who received intraforaminal steroid injections.
Mechanical needle damage
Excluded by the authors as the cause of the tissue damageThus, we could exclude that the tissue damage was due to the mechanical action of the needle.
Authors' conclusion
Ozone therapy procedures can be associated with several major complications; a revision of the guidelines and protocols is indispensable

Source: Abstract on PubMed

Safety as reported

Hard adhesions, with the nerve root contracted and adherent to the dural sac or disc, found at surgery only in patients previously given intraforaminal ozoneThese specific pathological patterns were observed only in the patients who received ozone injections by the intraforaminal approach.

Source: Abstract on PubMed

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