The present single blind randomized clinical trial is designed to evaluate the feasibility of ultrasound guided epidural steroid injection and compare the effects with standard fluoroscopic technique in patients presented with lower lumbar radicular pain. 30 patients aged between 15-70 years who meet the inclusion criteria recruited in the study. the patients are randomly divided in two groups of 15, each group is assigned each technique. under proper position, a Tuohy epidural needle G-18 is inserted and after negative aspiration, 1-2 ml of contrast agent is injected. contrast distribution pattern is evaluated regarding filling the epidural space. Injection duration and adverse effects (if any) are recorded nin patients' profiles. all the patients are re-evaluated 48 hrs and two weeks after the intervention. to assure blindness, evaluation of all radiologic images and also patients' examinations are done by a colleague, blind to the injection technique.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091629832N1
Registration date:2017-05-13, 1396/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-13, 1396/02/23
Registrant information
Name
SeyedMohammadReza Hajiseyedaboutorabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 2252
Email address
aalaei@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasound-guided vs. fluoroscopic-guided epidural steroid injection in lower lumbar radicular pain: a prospective, randomized, single-blind clinical trial.
Public title
comparison of two technique of sonography and fluoroscopy in epidural steroid injection for lumbar back pain
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria:
age between 15-70 years; diagnosis of intervertebral disc herniation or canal stenosis confirmed by clinical history & examination, EMG, CT or MRI tests.
exclusion criteria:
systemic inflammatory diseases; being under treatment by anti-coagulants; need to consume NSAIDs;
uncontrolled diabetes; history of allergic reaction to contrast agents; history of injection or surgery during past 3 months; infection; skin defect in injection site; psychotic problems.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani Hospital, Arabi Ave. Yaman St. Chamran Exp.
City
Tehran
Postal code
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.1012
Health conditions studied
1
Description of health condition studied
Radicular lumbar pain
ICD-10 code
M54.1
ICD-10 code description
Radiculopathy
Primary outcomes
1
Description
contrast distribution pattern
Timepoint
during the intervention
Method of measurement
compatible/ non-compatible with the research standard protocol
Secondary outcomes
1
Description
pain
Timepoint
Before the intervention - 48 hrs and two weeks after the intervention
Method of measurement
0-10 based on VAS
2
Description
Function
Timepoint
Before the intervention - 48 hrs and two weeks after the intervention
Method of measurement
0-100 basedon ODI
3
Description
patients satisfaction
Timepoint
48 hrs and two weeks after the intervention
Method of measurement
0-5 based on PSQ
4
Description
adverse effects
Timepoint
During the intervention - 48 hrs and two weeks after the intervention
Method of measurement
examination
5
Description
duration of the injetion
Timepoint
During the intervention
Method of measurement
based on seconds using cronometer
Intervention groups
1
Description
intervention group:
epidural injection of 8ml triamcinolone, 2ml marcaine .05% and 1 ml non-ionic contrast agent under the guide of ultrasound
Category
Treatment - Other
2
Description
Control group:
epidural injection of 8ml triamcinolone, 2ml marcaine .05% and 1 ml non-ionic contrast agent under the guide of flouroscope
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Dr. Alireza Glinimoghadam
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Imam-Hossein Hospital
Full name of responsible person
Dr. Alireza Glinimoghadam
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice president of research, Shahid Behehsti University of Medical Sciences, Dr.Ziaee
Full name of responsible person
Seyed-masoud Hashemi
Street address
3rd floor, Medical School, Next to Taleghani Hospital, Evin, Chamran Exp.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice president of research, Shahid Behehsti University of Medical Sciences, Dr.Ziaee
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Glini-moghaddam
Position
Pain Fellowship resident
Other areas of specialty/work
Street address
Pain Clinic, Akhtra Hospital, Elahie
City
Tehran
Postal code
Phone
+98 21 2261 2252
Fax
Email
homeopathylover@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed-Masoud Hashemi
Position
Associated Prof.
Other areas of specialty/work
Street address
Pain Clinic, Akhtar hospital, Elahie
City
Tehran
Postal code
Phone
+98 21 2261 2252
Fax
Email
dr.hashemi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Glini-moghadam
Position
Pain Fellowship resident
Other areas of specialty/work
Street address
Tehran, Elahie
City
Tehran
Postal code
Phone
+98 912 031 2927
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)