Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
Overview
- Phase
- Phase 2
- Intervention
- Discectomy/ micro discectomy
- Conditions
- Lumbar Herniated Disc
- Sponsor
- Kovacs Foundation
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Discectomy/micro discectomy
Intervention: Discectomy/ micro discectomy
1
Discectomy/micro discectomy
Intervention: Ozone therapy
1
Discectomy/micro discectomy
Intervention: Oxygen therapy
2
Intradiscal ozone infiltration
Intervention: Ozone therapy
2
Intradiscal ozone infiltration
Intervention: Oxygen therapy
3
Intradiscal oxygen infiltration (control arm)
Intervention: Oxygen therapy
Outcomes
Primary Outcomes
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
- To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy(12 months)