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The Effect of Ozone Therapy for Lumbar Herniated Disc

Primary Purpose

Lumbar Herniated Disc

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Discectomy/ micro discectomy
Ozone therapy
Oxygen therapy
Sponsored by
Kovacs Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Herniated Disc focused on measuring disc herniation, lumbar, ozone therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Negrín

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Discectomy/micro discectomy

Intradiscal ozone infiltration

Intradiscal oxygen infiltration (control arm)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2007
Last Updated
August 22, 2019
Sponsor
Kovacs Foundation
Collaborators
Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)
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1. Study Identification

Unique Protocol Identification Number
NCT00566007
Brief Title
The Effect of Ozone Therapy for Lumbar Herniated Disc
Official Title
Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
It has proved extremely difficult
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kovacs Foundation
Collaborators
Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Herniated Disc
Keywords
disc herniation, lumbar, ozone therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Discectomy/micro discectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intradiscal ozone infiltration
Arm Title
3
Arm Type
Active Comparator
Arm Description
Intradiscal oxygen infiltration (control arm)
Intervention Type
Procedure
Intervention Name(s)
Discectomy/ micro discectomy
Intervention Description
Standard discectomy or micro discectomy
Intervention Type
Drug
Intervention Name(s)
Ozone therapy
Intervention Description
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
Intervention Type
Drug
Intervention Name(s)
Oxygen therapy
Intervention Description
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD
Organizational Affiliation
Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francisco Robaina, MD
Organizational Affiliation
Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Negrín
City
Las Palmas de Gran Canaria
State/Province
Canary Islands
ZIP/Postal Code
35010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12748111
Citation
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.
Results Reference
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PubMed Identifier
15891150
Citation
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.
Results Reference
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PubMed Identifier
8324077
Citation
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.
Results Reference
background
PubMed Identifier
10488513
Citation
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.
Results Reference
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The Effect of Ozone Therapy for Lumbar Herniated Disc

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