The Effect of Ozone Therapy for Lumbar Herniated Disc

• ClinicalTrials.gov Identifier: NCT00566007
• Recruitment Status: Terminated
• First Posted: November 30, 2007
• Last Update Posted: August 28, 2019
• Sponsor: Kovacs Foundation
• Collaborators: Fondo de Investigacion Sanitaria; Hospital Negrín; Hospital Son Llatzer; Servicio de Salud de las Islas Baleares (Ib-Salut)
• Information provided by (Responsible Party): Kovacs Foundation

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
• Study Start Date: December 2008
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Spain

Hospital Negrín

Las Palmas de Gran Canaria, Canary Islands, Spain, 35010

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 (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.

• Responsible Party: Kovacs Foundation
• ClinicalTrials.gov Identifier: NCT00566007
• Other Study ID Numbers: FK-R-21
• First Posted: November 30, 2007
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Keywords provided by Kovacs Foundation:

disc herniation; lumbar; ozone therapy

Additional relevant MeSH terms:

Intervertebral Disc Displacement; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical