- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03023969
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
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
Study Overview
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 71111
- Emad Zarief Kamel Said
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group A
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
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receive 10 ml of ozone oxygen mixture under variable dosing
|
Active Comparator: group B
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
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receive 10 ml of ozone oxygen mixture under variable dosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain alleviation by visual analogue scale (VAS)
Time Frame: 12 months
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assessing pain alleviation by visual analogue scale (VAS)
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of disk herniation by MRI
Time Frame: 6 months
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evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
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6 months
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Pain alleviation using Oswestry Low Back Pain Questionnaire
Time Frame: 12 months
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using Oswestry Low Back Pain Questionnaire
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00009908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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