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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023969
• Other study ID #: IRB00009908
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 5, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Pain, Chronic

Intervention

Drug:
• ozone oxygen mixture
receive 10 ml of ozone oxygen mixture under variable dosing

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain alleviation by visual analogue scale (VAS)	assessing pain alleviation by visual analogue scale (VAS)	12 months
Secondary	Reduction of disk herniation by MRI	evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI	6 months
Secondary	Pain alleviation using Oswestry Low Back Pain Questionnaire	using Oswestry Low Back Pain Questionnaire	12 months