to detect the effect of sonographic guided transforaminal lumbar injection on pain in patients with lumbar radiculopathy
Design
a clinical trial without randomization on 30 patients with lumbar radiculopathy
Settings and conduct
this study was done in shahid behesti hospital, babol city.the ultrasound guided transforaminal injection is done and the level and the situation of needle was controlled with fluoroscopy after injection of radiopaque agent and documented, at that time the corticosteroid (triamcinolone) was injected. Also pain score for patients was documented in 1st, 3rd and 7th days and also first and 3rd months after injection.
Participants/Inclusion and exclusion criteria
Inclusion:low back pain or radicular pain with evidence of pressure and stenosis of the nerve root canal displayed in a recent MRI
exclusion: contraindication for epidural injection, overweight (30 <BMI), have had previous epidural injection, non-stable neurological problems like Cauda equina syndrome and also patients who did not cooperate in the investigation
Intervention groups
On prone position, with the curve of ultrasound transducer on the parasagittal oblique position, with out-of-plane technique a peripheral venous catheter (# 16) was advanced to the lamina, then the transducer position was changed to axial position and an Epidural catheter was placed about 8 Cm from midline and advanced under sonography guide with the in plane technique to the intervertebral foramen. The level and the situation of needle was controlled with fluoroscopy the corticosteroid (triamcinolone) was injected. Also pain score for patients was documented in 1st, 3rd and 7th days and also first and 3rd months after injection.
Main outcome variables
pain score based on visual assessment score (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200805048309N1
Registration date:2020-08-16, 1399/05/26
Registration timing:retrospective
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
behnam baghianimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 4392
Email address
b.baghianimoghadam@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-07-11, 1396/04/20
Actual recruitment end date
2017-07-11, 1396/04/20
Trial completion date
2017-07-11, 1396/04/20
Scientific title
a survey on sonographic guided transforaminal injection on pain among patients with lumbar radiculopathy
Public title
sonographic guided transforaminal lumbar injection on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
low back pain and also radicular pain of one or both lower extremities
evidence of pressure and stenosis of the nerve root canal in one or more levels displayed in a recent MRI which was not alleviated by initial conservative treatment
Exclusion criteria:
contraindication for epidural injection
overweight (30 <BMI)
previous epidural injection
non-stable neurological problems
not cooperate in the investigation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Ganjafrooz street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4717647754
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
9542923
Health conditions studied
1
Description of health condition studied
radicular low back pain
ICD-10 code
M48.0
ICD-10 code description
Spinal stenosis
Primary outcomes
1
Description
pain score based on visual assessment score (VAS)
Timepoint
before and after injection
Method of measurement
VAS (Visual assessment score) for pain assessment
Secondary outcomes
1
Description
accuracy of injection site
Timepoint
after injection
Method of measurement
fluoroscopic guided imaging as gold standard
Intervention groups
1
Description
Intervention group: at first under guidance of sonography a needle inserted into transforaminal space, then the position of needle checked by fluoroscope. then 1.5 ML of lidocaine 1% and 2ML of triamncinolone 40% injected into space. then the pain score measures with VAS score at 1st, 3rd, 7th dyas and also fist and 3rd months after injection.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital, Babol, Iran
Full name of responsible person
Behnam Baghianimoghadam
Street address
Ghasemi street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 4392
Email
behnam.baghian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mani Falsafi
Street address
Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
47176
Phone
+98 11 3219 9592
Email
drmanifalsafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Behnam Baghianimoghadam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghasemi street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 4392
Email
behnam.baghian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Behnam Baghianimoghadam
Position
Aassistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghasemi street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 4392
Email
behnam.baghian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Behnam Baghianimoghadam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghasemi street
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 4392
Email
behnam.baghian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
this study is about a new sonographic guided injection technique and we prefer to save our new innovation until its publication
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
final results could be share
When the data will become available and for how long
immediately after results publication
To whom data/document is available
there is no limit to access
Under which criteria data/document could be used
there is no limit to access
From where data/document is obtainable
please email to:
Behnam.baghian@gmail.com
What processes are involved for a request to access data/document