The Effect of Ozone Therapy for Lumbar Herniated Disc

Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery

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 Overview

• Status: Terminated
• Conditions: Lumbar Herniated Disc
• Intervention / Treatment: Procedure: Discectomy/ micro discectomy; Drug: Ozone therapy; Drug: Oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Canary Islands
    • Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
      • Hospital Negrín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy	12 months

Collaborators and Investigators

• Sponsor: Kovacs Foundation
• Collaborators: Fondo de Investigacion Sanitaria; Hospital Son Llatzer; Hospital Negrín; 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 29, 2007
• First Submitted That Met QC Criteria: November 29, 2007
• First Posted (Estimate): November 30, 2007

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: lumbar; disc herniation; ozone therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: FK-R-21