The Effect of Ozone Therapy for Lumbar Herniated Disc

NCT00566007 | Terminated Phase 2 DMC

• 1 other identifier: FK-R-21
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Herniated Disc

Keywords

disc herniation; lumbar; ozone therapy

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)

  12 months

Secondary Outcomes (1)

• To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy

  12 months

Study Arms (3)

1

ACTIVE COMPARATOR

Discectomy/micro discectomy

Procedure: Discectomy/ micro discectomy; Drug: Ozone therapy; Drug: Oxygen therapy

2

ACTIVE COMPARATOR

Intradiscal ozone infiltration

Drug: Ozone therapy; Drug: Oxygen therapy

3

ACTIVE COMPARATOR

Intradiscal oxygen infiltration (control arm)

Drug: Oxygen therapy

Interventions

Discectomy/ micro discectomy PROCEDURE

Standard discectomy or micro discectomy

1

Ozone therapy DRUG

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

1; 2

Oxygen therapy DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kovacs Foundation: lead
• Fondo de Investigacion Sanitaria: collaborator
• Hospital Negrín: collaborator
• Hospital Son Llatzer: collaborator
• Servicio de Salud de las Islas Baleares (Ib-Salut): collaborator

Study Sites (1)

Hospital Negrín

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

Location

Related Publications (5)

• 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.

  PMID: 12748111 BACKGROUND

• 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.

  PMID: 15891150 BACKGROUND

• 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.

  PMID: 8324077 BACKGROUND

• 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.

  PMID: 10488513 BACKGROUND

• Bisshopp S, Linertova R, Carames MA, Szolna A, Jorge IJ, Navarro M, Melchiorsen B, Rodriguez-Diaz B, Gonzalez-Martin JM, Clavo B. Pain Relief, Disability, and Hospital Costs After Intradiscal Ozone Treatment or Microdiscectomy for Lumbar Disc Herniation: A 24-Month Real-World Prospective Study. J Clin Med. 2025 Jun 26;14(13):4534. doi: 10.3390/jcm14134534.

  PMID: 40648907 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Diskectomy; Oxygen

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY CHAIR

• Bernardino Clavo, MD

  Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain

  STUDY DIRECTOR

• Francisco Robaina, MD

  Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: December 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

ES (1)