Lumbar Herniated DiscPhase 2NCT00566007
The Effect of Ozone Therapy for Lumbar Herniated Disc
A Phase 2 study testing Discectomy/ micro discectomy, Ozone therapy and Oxygen therapy in people with Lumbar Herniated Disc, run by Kovacs Foundation at 1 site in Spain.
Trial summary
The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Herniated Disc
- What is being tested?
- Discectomy/ micro discectomy, Ozone therapy and Oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of herniated disc by surgeons from participating hospitals
- Sciatic pain of 5 or more on Visual Analogue Scale
- Pain radiated to appropriate area according to herniated disc
- On waiting list for disc surgery at one of participating hospitals
Who cannot join
- Inability to fill out questionnaires (VAS, Roland Morris, SF12)
- Calcified or migrated herniated disc
- Herniated disc with indications for laminectomy or arthrodesis
- Clinically relevant partial paralysis
- Simultaneous cervical and dorsal symptomatic herniated discs
- Previous lumbar spine surgery
Show all 10Show fewer
- Presence of other spinal pathology
- Significant glucose-6-phosphate-dehydrogenase deficit
- Allergy to ozone
- Treatment with oral anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery.
- Conditions
- Lumbar Herniated Disc
- Being tested
- Discectomy/ micro discectomy, Ozone therapy, Oxygen therapy
- Keywords
- disc herniation, lumbar, ozone therapy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discectomy/ micro discectomyProcedure or surgery
Standard discectomy or micro discectomy
Ozone therapyDrug
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Oxygen therapyDrug
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Discectomy/micro discectomy Receives: Procedure: Discectomy/ micro discectomy; Drug: Ozone therapy; Drug: Oxygen therapy |
| 2 | Active comparator | Intradiscal ozone infiltration Receives: Drug: Ozone therapy; Drug: Oxygen therapy |
| 3 | Active comparator | Intradiscal oxygen infiltration (control arm) Receives: Drug: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
Measured: 12 months
Secondary outcomes (1)
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startDec 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: It has proved extremely difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Herniated DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)
- Responsible party
- Sponsor
- Investigators
- Francisco M Kovacs, MD, PhD, Study chair, Kovacs Foundation, Palma de Mallorca, 07012, SpainBernardino Clavo, MD, Study director, Hospital Negrín, Las Palmas de Gran Canaria, 35010 SpainFrancisco Robaina, MD, Principal investigator, Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566007
- Sponsor's protocol ID
- FK-R-21
- Status last verified
- Aug 2019
- First submitted
- 29 Nov 2007
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally invasive oxygen-ozone therapy for lumbar disk herniation. AJNR Am J Neuroradiol. 2003 May;24(5):996-1000.
PubMed 12748111Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000.
PubMed 15891150Bocci V, Luzzi E, Corradeschi F, Paulesu L, Di Stefano A. Studies on the biological effects of ozone: 3. An attempt to define conditions for optimal induction of cytokines. Lymphokine Cytokine Res. 1993 Apr;12(2):121-6.
PubMed 8324077Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.
PubMed 10488513Bisshopp S, Linertova R, Carames MA, Szolna A, Jorge IJ, Navarro M, Melchiorsen B, Rodriguez-Diaz B, Gonzalez-Martin JM, Clavo B. Pain Relief, Disability, and Hospital Costs After Intradiscal Ozone Treatment or Microdiscectomy for Lumbar Disc Herniation: A 24-Month Real-World Prospective Study. J Clin Med. 2025 Jun 26;14(13):4534. doi: 10.3390/jcm14134534.
PubMed 40648907
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
- ClinicalTrials.gov ID
- NCT00566007
- Acronym / sponsor ID
- FK-R-21
- Conditions
- Lumbar Herniated Disc
- Keywords
- disc herniation, lumbar, ozone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It has proved extremely difficult
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)
- Study start
- Dec 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Discectomy/ micro discectomy, Drug: Ozone therapy, Drug: Oxygen therapyDiscectomy/micro discectomy |
| 2 | Active comparator | Drug: Ozone therapy, Drug: Oxygen therapyIntradiscal ozone infiltration |
| 3 | Active comparator | Drug: Oxygen therapyIntradiscal oxygen infiltration (control arm) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of herniated disc by surgeons from participating hospitals
- Sciatic pain of 5 or more on Visual Analogue Scale
- Pain radiated to appropriate area according to herniated disc
- On waiting list for disc surgery at one of participating hospitals
Key exclusion criteria (10 listed)
- Inability to fill out questionnaires (VAS, Roland Morris, SF12)
- Calcified or migrated herniated disc
- Herniated disc with indications for laminectomy or arthrodesis
- Clinically relevant partial paralysis
- Simultaneous cervical and dorsal symptomatic herniated discs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discectomy/ micro discectomyStandard discectomy or micro discectomy | Procedure or surgery | 1 |
| Ozone therapyInfiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic | Drug | 1, 2 |
| Oxygen therapyIntradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic | Drug | 1, 2, 3 |
Primary outcome
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
Time frame: 12 months
1 secondary outcome
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy
Time frame: 12 months
Results and safety
The study was stopped early (reason given: It has proved extremely difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 12748111Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally invasive oxygen-ozone therapy for lumbar disk herniation. AJNR Am J Neuroradiol. 2003 May;24(5):996-1000.
- Background: PubMed 15891150Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000.
- Background: PubMed 8324077Bocci V, Luzzi E, Corradeschi F, Paulesu L, Di Stefano A. Studies on the biological effects of ozone: 3. An attempt to define conditions for optimal induction of cytokines. Lymphokine Cytokine Res. 1993 Apr;12(2):121-6.
- Background: PubMed 10488513Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.
- Derived from this study: PubMed 40648907Bisshopp S, Linertova R, Carames MA, Szolna A, Jorge IJ, Navarro M, Melchiorsen B, Rodriguez-Diaz B, Gonzalez-Martin JM, Clavo B. Pain Relief, Disability, and Hospital Costs After Intradiscal Ozone Treatment or Microdiscectomy for Lumbar Disc Herniation: A 24-Month Real-World Prospective Study. J Clin Med. 2025 Jun 26;14(13):4534. doi: 10.3390/jcm14134534.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Kovacs, MD, PhD study chair
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Bernardino Clavo, MD study director
Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
Francisco Robaina, MD principal investigator
Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Discectomy/ micro discectomy, Ozone therapy and Oxygen therapy in people with Lumbar Herniated Disc, run by Kovacs Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It has proved extremely difficult). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00566007, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.