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Variable Approaches of Intradiscal O3-O2 Injection

NCT ID: NCT03038529

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Keywords

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low back pain , Ozone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type OTHER

Classic postrolateral extraarticular percutaneous approach for O3 injection

Intervention Type PROCEDURE

Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach

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).

Group Type ACTIVE_COMPARATOR

Postrolateral transforaminal approach (Yess approach ) for O3 injection

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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 ).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Lecturer of Anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelraheem Alawaamy, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00009903

Identifier Type: -

Identifier Source: org_study_id