Variable Approaches of Intradiscal O3-O2 Injection

Study Overview
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Brief Summary
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Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain. Does change of injection approach make a difference?

Detailed Description
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Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief. A lot of injection approaches are available, but which offers the best results, is the question.

Official Title
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Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection
* Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: radicular leg pain low back pain non-responsive to conservative treatment Exclusion Criteria: patient refusal infection at injection site coagulopathy uncontrolled or degenerative spine disease pregnancy multilevel disk involvement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A: Classic approach<br>Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach. The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). | Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection<br>* Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach<br>|
| Active Comparator: B: Transforaminal approach (Yess approach )<br>Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach). The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy). | Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection<br>* Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of pain alleviation (visual analog scale) | assessing visual analog scale (VAS) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia reduction (percent) | the percent of analgesia reduction | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain , Ozone