Back to resultsImplication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ozone oxygen mixture
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
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.
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group A
group B
Arm Description
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
Outcomes
Primary Outcome Measures
Pain alleviation by visual analogue scale (VAS)
assessing pain alleviation by visual analogue scale (VAS)
Secondary Outcome Measures
Reduction of disk herniation by MRI
evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
Pain alleviation using Oswestry Low Back Pain Questionnaire
using Oswestry Low Back Pain Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03023969
Brief Title
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
Arm Title
group B
Arm Type
Active Comparator
Arm Description
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
Intervention Type
Drug
Intervention Name(s)
ozone oxygen mixture
Intervention Description
receive 10 ml of ozone oxygen mixture under variable dosing
Primary Outcome Measure Information:
Title
Pain alleviation by visual analogue scale (VAS)
Description
assessing pain alleviation by visual analogue scale (VAS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction of disk herniation by MRI
Description
evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
Time Frame
6 months
Title
Pain alleviation using Oswestry Low Back Pain Questionnaire
Description
using Oswestry Low Back Pain Questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29357333
Citation
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.
Results Reference
derived
Learn more about this trial
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
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