| November 29, 2007 |
| December 15, 2008 |
| December 2008 |
| To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for
ozone) [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| 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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Lumbar Herniated Disc |
- Procedure: Discectomy/ micro discectomy
- Drug: Ozone therapy
- Drug: Oxygen therapy
|
- Active Comparator: Discectomy/micro discectomy
- Active Comparator: Intradiscal ozone infiltration
- Active Comparator: Intradiscal oxygen infiltration (control arm)
|
- 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. 1999 Sep 1;24(17):1820-32.
|
| |
| Recruiting |
| 156 |
| January 2014 |
| September 2013 (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
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| Spain |
|
| |
| NCT00566007 |
| Bernardino Clavo, Servicio de Oncología RT, Unidad de Investigación, Hospital Negrín |
|
| 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 |
| December 2008 |
