The Effect of Ozone Therapy for Lumbar Herniated Disc - Full Text View

Sponsors and Collaborators:	Kovacs Foundation 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

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 II

MedlinePlus related topics: Anesthesia Ozone

Drug Information available for: Corticosteroids

U.S. FDA Resources

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

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
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator 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, Canary Islands
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:

Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally invasive oxygen-ozone therapy for lumbar disk herniation. AJNR Am J Neuroradiol. 2003 May;24(5):996-1000.

Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000.

Bocci V, Luzzi E, Corradeschi F, Paulesu L, Di Stefano A. Studies on the biological effects of ozone: 3. An attempt to define conditions for optimal induction of cytokines. Lymphokine Cytokine Res. 1993 Apr;12(2):121-6.

Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine. 1999 Sep 1;24(17):1820-32.

Responsible Party:	Hospital Negrín ( Bernardino Clavo, Servicio de Oncología RT, Unidad de Investigación )
Study ID Numbers:	FK-R-21
Study First Received:	November 29, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00566007
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Kovacs Foundation:

disc herniation
lumbar
ozone therapy

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Hernia
Intervertebral Disk Displacement
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009