Could ozone injections spare some back pain sufferers from surgery?
NCT ID NCT03282695
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are studying ozone therapy in adults who have a herniated lumbar disc and are on a waiting list for discectomy or microdiscectomy. Participants receive ozone injections and are followed for up to two years. The study measures changes in sciatic and lumbar pain, how many people still go through with surgery, and the direct hospital costs of their care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ozone therapy, an injection of ozone gas into the affected area
- What this could lead to
- If ozone injections ease sciatic and back pain enough, some people on a surgery waiting list might avoid or delay an operation, and hospitals could spend less on disc surgery.
- What could go wrong
- This is a small, single-group study without a placebo comparison, so any pain relief could reflect the natural course of a herniated disc rather than the ozone itself. Injections near the spine carry small risks of infection, bleeding, or nerve irritation.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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70 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults with symptomatic lumbar herniated disc in whom conservative medical management has failed and: 1) in whom discectomy or microdiscectomy is indicated, 2) have been included in surgery waiting list by the Neurosurgery Department, 3) who meet criteria for potential benefit with ozone therapy and 4) who accept participating in the study by answering/filling in the specific study questionnaires (wether they accept or not the ozone therapy).
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed with a herniated and not calcified lumbar disc that presents as: not migrated protrusion and/or extrusion. * Evaluated and diagnosed by the Neurosurgery Department, having been chosen as an appropriate candidate for surgery consisting in discectomy or microdiscectomy, after meeting the following two criteria: 1) Sciatic pain, with a visual analogue scale (VAS) intensity ≥ 5, despite 6 weeks of conservative management, wether it exists lumbar pain or not and 2) Radiating pain that matches the MRI image showing one or more herniated discs (not to be considered those patients with two herniated discs and symptoms attributable to only one of the herniated discs). * Included in the surgery waiting list for a discectomy or microdiscectomy. * Patients who have signed and dated the study 's specific informed consent. Exclusion Criteria: * Patients who do not meet all the inclusion criteria. * Calcified and/or migrated herniated disc, and/or with a severe neurological deficits (cauda equine syndrome). * Herniated disc with surgical indication of laminectomy and/or arthrodesis (massive extrusion, sign of instability or other conditions under the neurosurgeon judgment). * Relevant clinical paresis that does not improve despite 6 weeks of full conservative management (patients with severe pain and mild paresis that only shows up in the physical exam are not to be excluded, but those who present with paresis as the main symptom -"clinically relevant"- must be). * Simultaneous symptomatic cervical or dorsal herniated discs. * Previous lumbar spine surgery. * Concomitant spine conditions that may be causing symptoms or have indication for surgery (such as fractures or tumors). * Known allergy to ozone. * Those who are uncapable to fill in the scales used to measure variables in the study, like the visual analogue scale (VAS), Roland-Morris and SF-12 questionnaires. * Those who are unable or do not wish to fulfill the study 's protocol (answer questions to collect the data).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dr. Negrin University Hospital
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
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