NCT03023969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

January 12, 2017

Last Update Submit

February 5, 2017

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Pain alleviation by visual analogue scale (VAS)

    assessing pain alleviation by visual analogue scale (VAS)

    12 months

Secondary Outcomes (2)

  • Reduction of disk herniation by MRI

    6 months

  • Pain alleviation using Oswestry Low Back Pain Questionnaire

    12 months

Study Arms (2)

group A

ACTIVE COMPARATOR

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

Drug: ozone oxygen mixture

group B

ACTIVE COMPARATOR

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

Drug: ozone oxygen mixture

Interventions

ozone oxygen mixtureDRUG

receive 10 ml of ozone oxygen mixture under variable dosing

group Agroup B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, Asyut Governorate, 71111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 29357333DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and ICU

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 18, 2017

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

EG(1)