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

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Drug: ozone oxygen mixture

• Registration Number: NCT03023969
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-05
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	ozone oxygen mixture	percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
group A	ozone oxygen mixture	percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2

Primary Outcome Measures

Name	Time	Method
Pain alleviation by visual analogue scale (VAS)	12 months	assessing pain alleviation by visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Reduction of disk herniation by MRI	6 months	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	12 months	using Oswestry Low Back Pain Questionnaire

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt