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Variable Approaches of Intradiscal O3-O2 Injection

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Classic postrolateral extraarticular percutaneous approach for O3 injection

Postrolateral transforaminal approach (Yess approach ) for O3 injection

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain , Ozone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

A: Classic approach

B: Transforaminal approach (Yess approach )

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Quality of pain alleviation (visual analog scale)

assessing visual analog scale (VAS)

Secondary Outcome Measures

Analgesia reduction (percent)

the percent of analgesia reduction

Full Information

NCT ID

NCT03038529

First Posted

January 28, 2017

Last Updated

December 7, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03038529

Brief Title

Variable Approaches of Intradiscal O3-O2 Injection

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

October 30, 2016 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

low back pain , Ozone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Classic approach

Arm Type

Other

Arm Description

Arm Title

B: Transforaminal approach (Yess approach )

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Classic postrolateral extraarticular percutaneous approach for O3 injection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Postrolateral transforaminal approach (Yess approach ) for O3 injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Quality of pain alleviation (visual analog scale)

Description

assessing visual analog scale (VAS)

Time Frame

one year

Secondary Outcome Measure Information:

Title

Analgesia reduction (percent)

Description

the percent of analgesia reduction

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdelraheem Alawaamy, MD

Organizational Affiliation

Assiut University

Official's Role

Study Director

Facility Information:

Facility Name

Emad Zarief Kamel Said

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Variable Approaches of Intradiscal O3-O2 Injection

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