The Effect of Ozone Therapy for Lumbar Herniated Disc

Phase 2TerminatedNCT00566007

Kovacs Foundation156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Lumbar Herniated Disc

Interventions

Discectomy/ micro discectomyPROCEDURE

Standard discectomy or micro discectomy

Ozone therapyDRUG

Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic

Oxygen therapyDRUG

Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Negrín

Las Palmas de Gran Canaria, Canary Islands, Spain

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

Time frame: 12 months

Data from ClinicalTrials.gov

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