Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
156 participants
INTERVENTIONAL
2008-12-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Discectomy/micro discectomy
Discectomy/ micro discectomy
Standard discectomy or micro discectomy
Ozone therapy
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
2
Intradiscal ozone infiltration
Ozone therapy
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
3
Intradiscal oxygen infiltration (control arm)
Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
Interventions
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Discectomy/ micro discectomy
Standard discectomy or micro discectomy
Ozone therapy
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Presence of other spinal pathology
* Significant glucose-6-phosphate-dehydrogenase deficit
* Allergy to ozone
* Treatment with oral anticoagulants
18 Years
75 Years
ALL
No
Sponsors
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Fondo de Investigacion Sanitaria
OTHER
Hospital Negrín
UNKNOWN
Hospital Son Llatzer
OTHER
Servicio de Salud de las Islas Baleares (Ib-Salut)
UNKNOWN
Kovacs Foundation
OTHER
Responsible Party
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Principal Investigators
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Francisco M Kovacs, MD, PhD
Role: STUDY_CHAIR
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Bernardino Clavo, MD
Role: STUDY_DIRECTOR
Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
Francisco Robaina, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
Locations
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Hospital Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Countries
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References
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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.
Bonetti 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.
Bocci 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.
Gibson 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.
Bisshopp 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.
Other Identifiers
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FK-R-21
Identifier Type: -
Identifier Source: org_study_id
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