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The Effect of Ozone Therapy for Lumbar Herniated Disc

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ClinicalTrials.gov Identifier: NCT00566007
Recruitment Status : Suspended
First Posted : November 30, 2007
Last Update Posted : March 13, 2014
Sponsor:
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

November 29, 2007
November 30, 2007
March 13, 2014
December 2008
March 2014   (Final data collection date for primary outcome measure)
To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone) [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00566007 on ClinicalTrials.gov Archive Site
To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Lumbar Herniated Disc
  • 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: 1
    Discectomy/micro discectomy
    Interventions:
    • Procedure: Discectomy/ micro discectomy
    • Drug: Ozone therapy
    • Drug: Oxygen therapy
  • Active Comparator: 2
    Intradiscal ozone infiltration
    Interventions:
    • Drug: Ozone therapy
    • Drug: Oxygen therapy
  • Active Comparator: 3
    Intradiscal oxygen infiltration (control arm)
    Intervention: Drug: Oxygen therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
156
Same as current
April 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00566007
FK-R-21
Yes
Not Provided
Not Provided
Kovacs Foundation
Kovacs Foundation
  • Fondo de Investigacion Sanitaria
  • Hospital Negrín
  • Hospital Son Llatzer
  • Servicio de Salud de las Islas Baleares (Ib-Salut)
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
Kovacs Foundation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP