Variable Approaches of Intradiscal O3-O2 Injection

Assiut University

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection; Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03038529

IRB00009903

Details and patient eligibility

About

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?

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

A: Classic approach

Other group

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).

Treatment:

Procedure: Classic postrolateral extraarticular percutaneous approach for O3 injection

B: Transforaminal approach (Yess approach )

Active Comparator group

Description:

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).

Treatment:

Procedure: Postrolateral transforaminal approach (Yess approach ) for O3 injection