CClinicalTrials.gg
Sign In
TerminatedNCT00566007Updated Aug 28, 2019

The Effect of Ozone Therapy for Lumbar Herniated Disc

A Phase 2 interventional study of Discectomy/ micro discectomy and Ozone therapy in Lumbar Herniated Disc, sponsored by Kovacs Foundation. Terminated at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Kovacs Foundation · Phase 2, Interventional, and Treatment

Why this study was terminated
It has proved extremely difficult
Phase
Phase 2
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lumbar Herniated Disc

Keywords

  • disc herniation
  • lumbar
  • ozone therapy
03

In context

Intervertebral Disc Displacement

477 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.

This study's enrollment of 156 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Kovacs Foundation is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Presence of other spinal pathology
  • Significant glucose-6-phosphate-dehydrogenase deficit
  • Allergy to ozone
  • Treatment with oral anticoagulants
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Active comparator
    1

    Discectomy/micro discectomy

    Procedure: Discectomy/ micro discectomy · Drug: Ozone therapy · Drug: Oxygen therapy

  • Active comparator
    2

    Intradiscal ozone infiltration

    Drug: Ozone therapy · Drug: Oxygen therapy

  • Active comparator
    3

    Intradiscal oxygen infiltration (control arm)

    Drug: Oxygen therapy

Interventions

  • ProcedureDiscectomy/ micro discectomy

    Standard discectomy or micro discectomy

  • DrugOzone therapy

    Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic

  • DrugOxygen therapy

    Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic

06

What researchers measure

Primary outcomes

  1. To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)

    Time frame: 12 months

Secondary outcomes

  1. To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy

    Time frame: 12 months

07

Study locations

1 site
  • Hospital Negrín
    Las Palmas de Gran Canaria, Canary Islands 35010, Spain
08

References and documents

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 12748111 ↗
  • 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. PubMed 15891150 ↗
  • 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. PubMed 8324077 ↗
  • 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. PubMed 10488513 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00566007
Lead sponsor
Kovacs Foundation
Collaborators
Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)
Responsible party
Sponsor
First posted
Nov 30, 2007
Start date
Dec 2008
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Aug 28, 2019

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Intervertebral Disc Displacement→

Other studies from this sponsor

Kovacs Foundation

Start the discussion