Clinical trial NCT00566007: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lumbar Herniated Disc
Keywords: disc herniation
lumbar
ozone therapy
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Hospital Negrín
name: Hospital Son Llatzer
name: Servicio de Salud de las Islas Baleares (Ib-Salut)
First posted: 2007-11-30
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy
timeFrame: 12 months
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Negrín
state: Canary Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Negrín, Las Palmas de Gran Canaria, 35010 Spain
name: Bernardino Clavo, MD
role: STUDY_DIRECTOR
affiliation: Hospital Negrín, Las Palmas de Gran Canaria 35010 Spain
name: Francisco Robaina, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.