The Effect of Ozone Therapy for Lumbar Herniated Disc

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kovacs Foundation
• Collaborators: Fondo de Investigacion Sanitaria; Hospital Negrín; Hospital Son Llatzer; Servicio de Salud de las Islas Baleares (Ib-Salut)

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