The Effect of Ozone Therapy for Lumbar Herniated Disc
Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
  • Phase

    Phase 2
  • Study Type

  • Status

  • Intervention/Treatment

    ozone oxygen ...
  • Study Participants

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 Started
Dec 31
Primary Completion
Mar 31
Study Completion
Mar 31
Last Update
Aug 28

Procedure Discectomy/ micro discectomy

Standard discectomy or micro discectomy

Drug Ozone therapy

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

Drug Oxygen therapy

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

1 Active Comparator

Discectomy/micro discectomy

2 Active Comparator

Intradiscal ozone infiltration

3 Active Comparator

Intradiscal oxygen infiltration (control arm)


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:

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
No Results Posted