NCT00566007|TerminatedPhase 2DMC
Study Stopped
It has proved extremely difficult
The Effect of Ozone Therapy for Lumbar Herniated Disc
Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
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Sponsor study identifier
interventional
156
1 country
1
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2007
Actual (reported)November 30, 2007
Actual (reported)December 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 2014
Actual (reported)March 2014
Actual (reported)To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
12 months
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy
12 months
Discectomy/micro discectomy
Intradiscal ozone infiltration
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Hospital Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
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.
Francisco M Kovacs, MD, PhD
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Bernardino Clavo, MD
Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
Francisco Robaina, MD
Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
156 participants (actual enrollment reported by the registry).
First Submitted
November 29, 2007
First Posted
November 30, 2007
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Intradiscal oxygen infiltration (control arm)
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
Contact the study team to confirm eligibility.
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.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
August 28, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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