Effect of intradiscal ozone injection on various types of herniated lumbar disc
Design
A total of 128 patients with radicular back pain (Based on MRI and MSU Classification criteria), are divided into 8 groups of 16 patients. All patients are given written consent (After explaining about the method of work and possible complications).
Settings and conduct
According to inclusion and exclusion criterias, 128 patients are divided into 8 groups of 16 people. All patients are given written consent (After explaining about the method of work and possible complications). Then inside the nucleus pulposus (Under fluoroscope guidance), a mixture of ozone + oxygen is injected at a concentration of 29-32 μg / ml (within 15 to 20 seconds).
For all patients, the severity of pain (VAS) and the degree of disability (ODI)(Oswestry Disability Index) is assessed, before and one month and three months after injection. The physician who evaluates the patients after ozone injection is unaware of the type of herniated disc of the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: VAS (Visual Analogue Scale) larger or equal to 5;Radicular pain for more than 4 weeks and less than one year;CT scan or MRI findings with dermatomal distribution of pain and disc herniation at one level;SLR is less than 45 ° positive
exclusion criteria:Hemorrhagic diseases;Local infection;Uncontrolled diabetes; Pregnancy;Hyperparathyroidism;G6PD (Glucose-6-phosphate dehydrogenase) Deficiency;Unwillingness of the patient; Cauda equina syndrome symptoms
Intervention groups
According to the type of disk herniation (MSD classification), patients are divided into 8 different groups.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013364N5
Registration date:2018-02-04, 1396/11/15
Registration timing:retrospective
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-04-25, 1396/02/05
Actual recruitment end date
2018-01-16, 1396/10/26
Trial completion date
empty
Scientific title
Effect of intradiscal ozone injection on various types of herniated lumbar disc
Public title
Effect of intradiscal ozone injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having VAS ≥ 5
Radicular pain for more than 4 weeks and less than one year
CT scan or MRI findings with dermatomal distribution of pain and disc herniation at one level
SLR is less than 45 ° positive
Exclusion criteria:
Hemorrhagic diseases
Local infection
Uncontrolled diabetes
Pregnancy
Hyperparathyroidism
G6PD Deficiency
Unwillingness of the patient
Cauda equina syndrome symptoms
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who evaluates the patients after ozone injection is unaware of the type of herniated disc of the patient.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.111
Health conditions studied
1
Description of health condition studied
disk herniation
ICD-10 code
M54.40
ICD-10 code description
Lumbago with sciatica, unspecified side
Primary outcomes
1
Description
pain
Timepoint
At the beginning of the study, 1 and 3 months after the ozone injection
Method of measurement
VAS
2
Description
disability
Timepoint
At the beginning of the study, 1 and 3 months after the ozone injection
Method of measurement
ODI (Oswestry Disability Index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Inside the nucleus pulposus (Under fluoroscope guidance), a mixture of ozone + oxygen is injected at a concentration of 29-32 μg / ml (within 15 to 20 seconds).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mehrdad Taheri
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the initial and main implications
When the data will become available and for how long
Since 2018
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Mehrdad Taheri
taheri.1352@yahoo.com
What processes are involved for a request to access data/document