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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03038529

Enrollment

100

Registered

2017-01-31

Start date

2015-01-01

Completion date

2016-11-30

Last updated

2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain , Ozone

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.

Interventions

PROCEDUREClassic 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

PROCEDUREPostrolateral 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 ).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026