The Effect of Ozone Therapy for Lumbar Herniated Disc

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00566007

Enrollment

156

Registered

2007-11-30

Start date

2008-12-31

Completion date

2014-03-31

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Herniated Disc

Keywords

disc herniation, lumbar, ozone therapy

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)	12 months

Secondary

Measure	Time frame
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy	12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026