Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Kovacs Foundation Fondo de Investigacion Sanitaria Hospital Negrín Hospital Son Llatzer Servicio de Salud de las Islas Baleares (Ib-Salut) |
---|---|
Information provided by: | Kovacs Foundation |
ClinicalTrials.gov Identifier: | NCT00566007 |
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.
Condition | Intervention | Phase |
---|---|---|
Lumbar Herniated Disc |
Procedure: Discectomy/ micro discectomy Drug: Ozone therapy Drug: Oxygen therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery |
Estimated Enrollment: | 156 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Discectomy/micro discectomy
|
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
|
2: Active Comparator
Intradiscal ozone infiltration
|
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
|
3: Active Comparator
Intradiscal oxygen infiltration (control arm)
|
Drug: Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francisco M Kovacs, MD, PhD | +34 971 720809 | kovacs@kovacs.org |
Contact: María Teresa Gil del Real, MPH | +34 91 3440244 | mtgildelreal@kovacs.org |
Spain, Canary Islands | |
Hospital Negrín | Recruiting |
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010 | |
Principal Investigator: Bernardino Clavo, MD | |
Hospital Negrín | Recruiting |
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010 | |
Principal Investigator: Francisco Robaina, MD |
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 |
Responsible Party: | Hospital Negrín ( Bernardino Clavo, Servicio de Oncología RT, Unidad de Investigación ) |
Study ID Numbers: | FK-R-21 |
Study First Received: | November 29, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00566007 |
Health Authority: | Spain: Spanish Agency of Medicines |
disc herniation lumbar ozone therapy |
Spinal Diseases Musculoskeletal Diseases Hernia Intervertebral Disk Displacement Bone Diseases |