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

NCT ID: NCT03023969

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

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 .

Conditions

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

ozone oxygen mixture

Intervention Type: DRUG

receive 10 ml of ozone oxygen mixture under variable dosing

group B

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

Group Type: ACTIVE_COMPARATOR

ozone oxygen mixture

Intervention Type: DRUG

receive 10 ml of ozone oxygen mixture under variable dosing

Interventions

ozone oxygen mixture

receive 10 ml of ozone oxygen mixture under variable dosing

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Emad Zarief , MD

Lecturer of Anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emad Zarief Kamel Said

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31.

Reference Type: DERIVED

PMID: 29357333 (View on PubMed)

Other Identifiers

IRB00009908

Identifier Type: -

Identifier Source: org_study_id