Variable Approaches of Intradiscal O3-O2 Injection

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection; Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection

• Registration Number: NCT03038529
• Lead Sponsor: Assiut University

Brief Summary

Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.

Does change of injection approach make a difference?

Detailed Description

Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.

A lot of injection approaches are available, but which offers the best results, is the question.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-10-30
• Study Completion: 2016-11-30
• Study First Submitted: 2017-01-28
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-01-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• radicular leg pain
• low back pain
• non-responsive to conservative treatment

Exclusion Criteria

• patient refusal
• infection at injection site
• coagulopathy
• uncontrolled or degenerative spine disease
• pregnancy
• multilevel disk involvement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Classic approach	Classic postrolateral extraarticular percutaneous approach for O3 injection	Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach. The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).
B: Transforaminal approach (Yess approach )	Postrolateral transforaminal approach (Yess approach ) for O3 injection	Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach). The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).

Primary Outcome Measures

Name	Time	Method
Quality of pain alleviation (visual analog scale)	one year	assessing visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Analgesia reduction (percent)	one year	the percent of analgesia reduction

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt