The Effect of Ozone Therapy for Lumbar Herniated Disc

Kovacs Foundation

Status and phase: Terminated; Phase 2

Conditions: Lumbar Herniated Disc

Treatments: Procedure: Discectomy/ micro discectomy; Drug: Oxygen therapy; Drug: Ozone therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00566007

FK-R-21

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

1

Active Comparator group

Description:

Discectomy/micro discectomy

Treatment:

Drug: Oxygen therapy

Procedure: Discectomy/ micro discectomy

Drug: Ozone therapy

2

Active Comparator group

Description:

Intradiscal ozone infiltration

Treatment:

Drug: Oxygen therapy

Drug: Ozone therapy

3

Active Comparator group

Description:

Intradiscal oxygen infiltration (control arm)

Treatment:

Drug: Oxygen therapy