Skip to main content
OpenTrials
Completed

NCT Number: NCT03038529

Variable Approaches of Intradiscal O3-O2 Injection

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Classic postrolateral extraarticular percutaneous approach for O3 injection

Procedure

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

Procedure

Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).

Primary outcomes

  1. Quality of pain alleviation (visual analog scale)

    Time frame: one year

    assessing visual analog scale (VAS)

Secondary outcomes

  1. Analgesia reduction (percent)

    Time frame: one year

    the percent of analgesia reduction

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2017
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.