Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain

Assiut University

Status: Completed

Conditions: Pain, Chronic

Treatments: Drug: ozone oxygen mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT03023969

IRB00009908

Details and patient eligibility

About

Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.

Full description

Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.

Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.

Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All patients Suffered radicular leg pain and some reported additional back pain.
• All patients are non-responsive to conservative treatment modalities with VAS more than 7.

Exclusion criteria

• presence of bleeding disorder
• local infection
• uncontrolled or degenerative spine disease
• pregnancy
• multilevel disk involvement
• patient refusal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

group A

Active Comparator group

Description:

percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2

Treatment:

Drug: ozone oxygen mixture

group B

Active Comparator group

Description:

percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.

Treatment:

Drug: ozone oxygen mixture