The Effect of Ozone Therapy for Lumbar Herniated Disc

Lumbar Herniated Disc Clinical Trial

Official title:

Trial on the Effect of Ozone Therapy for Lumbar Herniated Disc With Criteria for Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00566007
• Other study ID #: FK-R-21
• Status: Terminated
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: March 2014

Study information

• Verified date: August 2019
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 156
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Herniated Disc

Intervention

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
• Oxygen therapy
Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic

Locations

Country	Name	City	State
Spain	Hospital Negrín	Las Palmas de Gran Canaria	Canary Islands

Sponsors (5)

Lead Sponsor	Collaborator
Kovacs Foundation	Fondo de Investigacion Sanitaria, Hospital Negrín, Hospital Son Llatzer, Servicio de Salud de las Islas Baleares (Ib-Salut)

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone)		12 months
Secondary	To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy		12 months