Could ozone injections spare some back pain sufferers from surgery?

NCT ID NCT03282695

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

70 people

The number who actually took part.

Started

Mar 2018

Finished

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

18 to 75 years

Sex

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

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.

Intervertebral Disc Displacement lumbar disk disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dr. Negrin University Hospital

    Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

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