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

Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03023969

Enrollment

Registered

2017-01-18

Start date

2015-08-31

Completion date

2016-12-31

Last updated

2017-02-07

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

Conditions

Pain, Chronic

Brief summary

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.

Detailed 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 .

Interventions

DRUGozone oxygen mixture

receive 10 ml of ozone oxygen mixture under variable dosing

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Pain alleviation by visual analogue scale (VAS)	12 months	assessing pain alleviation by visual analogue scale (VAS)

Secondary

Measure	Time frame	Description
Reduction of disk herniation by MRI	6 months	evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
Pain alleviation using Oswestry Low Back Pain Questionnaire	12 months	using Oswestry Low Back Pain Questionnaire

Countries

Egypt

Outcome results

None listed

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