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Comparison of transforaminal ozone injection Vs triamcinolon infilteration on chronic radicular low back pain.

Protocol summary

Summary
Objectives: The aim of this study is evaluation of effect, safety and side effect of ozone as a new modality in treatment of radicular LBP. Design and participant including major eligibility criteria and setting and conduct: The sample size is 64 patients. the including radicular low back pain patients are randomly ordered by block randomiztion in two group and the study is double blinded which means that patients, research evalutors and study analyzer are not aware of treatment. intervention: While preforming the steroid method 20mg triamcinolone plus 5ml bupivacaine 0.2% and in the second group 10ml ozone 30mic/ml plus 5ml bupivacaine 0.2% per foramen are injecting. Main outcomes: pain score, disability index, Serum level of TNFα, physical examination and lab test (BUN, Cr , BS). in two group at end of week two and fourth intervention is repeating. at the start of study, end of week two, week fourth month three and six since start of study, pain questionnaire, ostwestry disability questionnaire, pain score (numerical rating scale) are accomplish and document recording. so at the start of treatment and the end of month two chronic pain biomarker TNFα and MRI are measure and results rcording for analysis and comparing.

General information

Acronym
none
IRCT registration information
IRCT registration number: IRCT201610177984N26
Registration date: 2017-02-12, 1395/11/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transforaminal ozone injection Vs triamcinolon infilteration on chronic radicular low back pain.
Public title
effect of ozone on low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria including: Radicular LBP that persistent more than 6 weeks; Root impression due to disc bulging or foraminal narrowing that confirmable in MRI; The patient age must be between 18 -70 yr old; Physical status level I to II according to ASA physical status classification system. Valid, written consent to participate in study must be obtained; Pain score must be more than 4 according to numerical rating scale(NRS)tool; Lack of pain relieve to medication and physical therapy; Three or less nerve root must be involved. Exclusion criteria including: If coagulopathy to exist; presence of systemic or zone of needle entry point infection; Severe anatomical distortion(for example scoliosis); presence history of back surgery or device implantation; Severe psychotic disorder is co-exist; history of allergy to local anesthetics is positive; if progressive deficiency or motor deficit to exist; If malignancy, pregnancy, or history of substance abuse, HIV and /or chronic hepatitis marker positive to exist; If acute trauma; or cauda equina syndrome to exist.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expressway corner
City
Tehran
Postal code
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.IUMS.REC.1395.28857

Health conditions studied

1

Description of health condition studied
low Back Pain
ICD-10 code
M54.4
ICD-10 code description
low Back Pain with Sciatica

Primary outcomes

1

Description
Pain
Timepoint
befor itervention will started,and the end of weeks two and four months three and six
Method of measurement
Nnmrical Rating Scale tool of pain

2

Description
chronic pain biomarker, TNFalpha in serum.
Timepoint
befor itervention will started,and the end of month two.
Method of measurement
Venous Blood sample

3

Description
Root Impression in MRI
Timepoint
Before intervention and the end of second month
Method of measurement
MRI imagine

Secondary outcomes

1

Description
disability
Timepoint
befor intervention will start,the end of weeks two and four,months three and six
Method of measurement
Oswestry Disability Questionnaire

2

Description
labratory data, BUN, Cr, Bs
Timepoint
befor intervention will start,the end of weeks two and four,months three and six
Method of measurement
Venous blood sample

3

Description
Dermatomal pain distribiotion,posetive SLR(and degree of), revres SLR
Timepoint
before intervention will start,the end of weeks two and four,month three and six
Method of measurement
Pain that induced with physical examination and it's distribution,degree of range of motion that induced pain,...

Intervention groups

1

Description
(10ml of 30micro/ml ozone +5ml bupivacaine 0.2%)per root.
Category
Treatment - Surgery

2

Description
20mg triamcinolone +5ml bupivacaine 0.2% per root will inject
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat- Rasul Akram Medical Coplex
Full name of responsible person
Farnad Imani
Street address
Anesthesiology and pain department of Hzrat-Rasoul Medical Complex Niayesh street, sattar-Khan Avenue.
City
Tahran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chansellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Musavi.
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tahran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chansellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hemmat Highway Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Anesthsiology Professor, Interventional Pain fellowship
Other areas of specialty/work
Street address
Hazrat Rasui Medical Complex, Niayess st, Sattar Khan Ave.
City
Tahran
Postal code
Phone
+98 21 6435 2326
Fax
Email
farnadimani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Professor of Anesthesiology, interventional pain fellowship .
Other areas of specialty/work
Street address
Anesthesia and pain department of Hazrat Rasul Medical complex, Niayesh st, Sattar-Khan avenue.
City
Tahran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
farnadimani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Professor of Anesthesiology, Interventional pain fellowship .
Other areas of specialty/work
Street address
Department of Anesthesiology and pain Hazrat Rasul Medical Complex, Niayesh St, Sattar Khan Avenue
City
Tahran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
Email
farnadimani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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