Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.

Detailed Description
-----------------
Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative. Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular. Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Official Title
-----------------
Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study

Conditions
-----------------
Pain, Chronic

Intervention / Treatment
-----------------
* Drug: ozone oxygen mixture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Suffered radicular leg pain and some reported additional back pain. All patients are non-responsive to conservative treatment modalities with VAS more than 7. Exclusion criteria presence of bleeding disorder local infection uncontrolled or degenerative spine disease pregnancy multilevel disk involvement patient refusal.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2 | Drug: ozone oxygen mixture<br>* receive 10 ml of ozone oxygen mixture under variable dosing<br>|
| Active Comparator: group B<br>percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2. | Drug: ozone oxygen mixture<br>* receive 10 ml of ozone oxygen mixture under variable dosing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain alleviation by visual analogue scale (VAS) | assessing pain alleviation by visual analogue scale (VAS) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of disk herniation by MRI | evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI | 6 months | 
| Pain alleviation using Oswestry Low Back Pain Questionnaire | using Oswestry Low Back Pain Questionnaire | 12 months |