Variable Approaches of Intradiscal O3-O2 Injection

Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.

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?

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection; Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A: Classic approach; 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).	Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection; Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach
Active Comparator: B: Transforaminal approach (Yess approach ); 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).	Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection; Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of pain alleviation (visual analog scale)	assessing visual analog scale (VAS)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia reduction (percent)	the percent of analgesia reduction	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Abdelraheem Alawaamy, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: low back pain , Ozone
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB00009903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No