A Comparative study of effects of epidural Methylprednisolone Asetate(Depo-Medrol) Injection on pain relief of patient with disc hernia of lumbar spine, with and without spinal canal stenosis
The aim of this study is to compare the effect of epidural steroid injection on pain relief in patients with disc hernia of lumbar spine, with and without spinal canal stenosis in MRI. 50 patients with history of chronic lumbar pain will be put into two groups in parallel fashion based on having evidence of disc hernia in lumbar spine with (25 cases) or without spinal canal stenosis (25 cases).80 Mg Methylprednisolone Asetate(Depo-Medrol) is injected to epidural space in lumbar region(L3-L5) for all two group patients. For access and identification of epidural space one of the two method of hanging drop, or loss of resistance is used. Injection will be done in scrubby operating room. Pain will be measured and recorded in two ways ,Visual Analog Scale, and Verbal Rating Pain Score , at 5 times: prior to injection; 48 hours; a week; one month and two months after the injection . Two groups of patients will be compared in relation to consumption of analgesic drugs too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809251766N2
Registration date:2010-02-16, 1388/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Karim Nasseri
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
nasseri_k@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2009-05-01, 1388/02/11
Expected recruitment end date
2010-05-01, 1389/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study of effects of epidural Methylprednisolone Asetate(Depo-Medrol) Injection on pain relief of patient with disc hernia of lumbar spine, with and without spinal canal stenosis
Public title
Study the effect of injection of steroids to lumbar region on pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria's: history of lumbar pain that radiculated to lower limb and continued for more than 6 month, history of intervertebral disc herniation with, or without spinal stenosis confirmed with MRI ,ASA class 1 or 2, ability to sign informed consents.
Exclusion criteria: age under 18,age above 60 ,neurologic deficit (such as paresis or plegia of limbs), past medical history of surgery on spinal canal, history of dependency or addiction to opioides
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan university medical sciences ethics committee
Street address
Pasdaran street
City
Sanandaj
Postal code
Approval date
2009-11-27, 1388/09/06
Ethics committee reference number
p14p8017-clause-6
Health conditions studied
1
Description of health condition studied
Lumbar and other intervertebral disc disorders with radiculopathy
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Pain relief
Timepoint
48 hrs, 1 week, 2 week, 1 month and 2 months later
Method of measurement
Visual Analogue Scale (VAS) and Verbal pain Rating scale
Secondary outcomes
1
Description
Using analgesic
Timepoint
During 2 month
Method of measurement
the amount ,kind and dosage (mg) of analgesic that used for pain relief
Intervention groups
1
Description
Injection a single doses of 80 Mg Methylprednisolone Asetete (Depo-Medrol)to lumbar epidural space(L3-L5) via a disposable 16G needle
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Karim nasseri
Street address
Keshavarze street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Ataaolah Haidari
Street address
Pasdaran Street
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Karim Nasseri
Position
Anesthetist / Assistant Professor
Other areas of specialty/work
Street address
Jam Jm Street, Sosangerd Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 3728
Fax
+98 87 1328 5890
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences, Faculty of Nursing
Full name of responsible person
Shoaleh Shami
Position
Master of Nursing
Other areas of specialty/work
Street address
Sosangerd Street -Jam Jam Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 0733
Fax
+98 87 1328 5890
Email
shami471@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Kurdistan University of Medical Sciences
Full name of responsible person
Karim Nasseri
Position
Anesthetist /Assistant Professor
Other areas of specialty/work
Street address
Jam Jam Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 3728
Fax
+98 87 1328 5890
Email
nasseri_k@muk.ac.ir ; bihoshi@gmail.com
Web page address
www.muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)