Variable Approaches of Intradiscal O3-O2 Injection

Low Back Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038529
• Other study ID #: IRB00009903
• Status: Completed
• Phase: N/A
• First received: January 28, 2017
• Last updated: December 7, 2017
• Start date: January 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• 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 ).

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of pain alleviation (visual analog scale)	assessing visual analog scale (VAS)	one year
Secondary	Analgesia reduction (percent)	the percent of analgesia reduction	one year