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The Effect of Ozone Therapy for Lumbar Herniated Disc

This study is currently recruiting participants.
Verified June 2011 by Kovacs Foundation
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Hospital Negrín
Hospital Son Llatzer
Servicio de Salud de las Islas Baleares (Ib-Salut)
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00566007
First received: November 29, 2007
Last updated: June 26, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Lumbar Herniated Disc
 Procedure: Discectomy/ micro discectomy
Drug: Ozone therapy
Drug: Oxygen therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: December 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Discectomy/micro discectomy
 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
Active Comparator: 2
Intradiscal ozone infiltration
 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
Active Comparator: 3
Intradiscal oxygen infiltration (control arm)
 Drug: Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566007

Contacts
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org

Locations
Spain
Hospital Negrín Recruiting
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
Principal Investigator: Bernardino Clavo, MD            
Hospital Negrín Recruiting
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
Principal Investigator: Francisco Robaina, MD            
Sponsors and Collaborators
Kovacs Foundation
Fondo de Investigacion Sanitaria
Hospital Negrín
Hospital Son Llatzer
Servicio de Salud de las Islas Baleares (Ib-Salut)
Investigators
Study Chair: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, 07012, Spain
Study Director: Bernardino Clavo, MD Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
Principal Investigator: Francisco Robaina, MD Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
  More Information

Publications:

Responsible Party: Bernardino Clavo, Servicio de Oncología RT, Unidad de Investigación, Hospital Negrín
ClinicalTrials.gov Identifier: NCT00566007     History of Changes
Other Study ID Numbers: FK-R-21
Study First Received: November 29, 2007
Last Updated: June 26, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Kovacs Foundation:
disc herniation
lumbar
ozone therapy

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013