The Effect of Ozone Therapy for Lumbar Herniated Disc

Phase 2

Terminated

• Conditions: Lumbar Herniated Disc
• Interventions: Drug: Ozone therapy; Procedure: Discectomy/ micro discectomy; Drug: Oxygen therapy

• Registration Number: NCT00566007
• Lead Sponsor: Kovacs Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Study Start: 2008-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ozone therapy	Intradiscal ozone infiltration
1	Ozone therapy	Discectomy/micro discectomy
1	Discectomy/ micro discectomy	Discectomy/micro discectomy
2	Oxygen therapy	Intradiscal ozone infiltration
1	Oxygen therapy	Discectomy/micro discectomy
3	Oxygen therapy	Intradiscal oxygen infiltration (control arm)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Negrín; 🇪🇸 Las Palmas de Gran Canaria, Canary Islands, Spain