The Effect of Ozone Therapy for Lumbar Herniated Disc

Study Overview
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Brief Summary
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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.

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

Conditions
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Lumbar Herniated Disc

Intervention / Treatment
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* Procedure: Discectomy/ micro discectomy
* Drug: Ozone therapy
* Drug: Oxygen therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Discectomy/micro discectomy | Procedure: Discectomy/ micro discectomy<br>* Standard discectomy or micro discectomy<br>Drug: Ozone therapy<br>* Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic<br>Drug: Oxygen therapy<br>* Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic<br>|
| Active Comparator: 2<br>Intradiscal ozone infiltration | Drug: Ozone therapy<br>* Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic<br>Drug: Oxygen therapy<br>* Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic<br>|
| Active Comparator: 3<br>Intradiscal oxygen infiltration (control arm) | Drug: Oxygen therapy<br>* Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disc herniation, lumbar, ozone therapy