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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2 |
|
| group B | Active Comparator | percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ozone oxygen mixture | Drug | receive 10 ml of ozone oxygen mixture under variable dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain alleviation by visual analogue scale (VAS) | assessing pain alleviation by visual analogue scale (VAS) | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emad Zarief Kamel Said | Asyut | Asyut Governorate | 71111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29357333 | Derived | Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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using Oswestry Low Back Pain Questionnaire
| 12 months |