Title
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 2Lead Sponsor
Kovacs FoundationStudy Type
InterventionalStatus
TerminatedIndication/Condition
Lumbar Herniated DiscStudy Participants
156The 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.
Standard discectomy or micro discectomy
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
Discectomy/micro discectomy
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
