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
Overview
- Phase
- Not Applicable
- Intervention
- ozone oxygen mixture
- Conditions
- Pain, Chronic
- Sponsor
- Assiut University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain alleviation by visual analogue scale (VAS)
- Status
- Completed
- Last Updated
- 9 years ago
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 .
Investigators
Emad Zarief , MD
Lecturer of Anesthesia and ICU
Assiut University
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
- •Exclusion criteria
- •presence of bleeding disorder
- •local infection
- •uncontrolled or degenerative spine disease
- •pregnancy
- •multilevel disk involvement
- •patient refusal.
Exclusion Criteria
- Not provided
Arms & Interventions
group A
percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
Intervention: ozone oxygen mixture
group B
percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
Intervention: ozone oxygen mixture
Outcomes
Primary Outcomes
Pain alleviation by visual analogue scale (VAS)
Time Frame: 12 months
assessing pain alleviation by visual analogue scale (VAS)
Secondary Outcomes
- Reduction of disk herniation by MRI(6 months)
- Pain alleviation using Oswestry Low Back Pain Questionnaire(12 months)