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The Effect of Ozone Therapy for Lumbar Herniated Disc

NCT00566007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Lumbar Herniated Disc

Interventions

PROCEDURE

Discectomy/ micro discectomy

Standard discectomy or micro discectomy

DRUG

Ozone therapy

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

DRUG

Oxygen therapy

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

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Hospital Negrín

    collaborator UNKNOWN

  • Hospital Son Llatzer

    collaborator OTHER

  • Servicio de Salud de las Islas Baleares (Ib-Salut)

    collaborator UNKNOWN

  • Kovacs Foundation

    lead OTHER

Principal Investigators

  • Francisco M Kovacs, MD, PhD · Kovacs Foundation, Palma de Mallorca, 07012, Spain

  • Bernardino Clavo, MD · Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain

  • Francisco Robaina, MD · Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566007 on ClinicalTrials.gov