The purpose of this study is to evaluate different methods of epidural steroid injection in recurrent lumbar discopathy. The inclusion criteria are pain, recurrent disc herniation after operation and no response after 2 weeks conservative treatment and exclusion criteria are severe disc extrusion and neurologic deficit. A total of 30 patients will be selected from patients who come back to the clinic of hospital due to recurrent pain after operation and accept the informed consent. The injection of 40mg Prednisolone will be done in two different methods (transforamial and caudal) in two group (15 patients in each group) and severity of pain, walking and standing tolerance will be measured as outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903084047N1
Registration date:2010-11-12, 1389/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-12, 1389/08/21
Registrant information
Name
Saeid Karamouzian
Name of organization / entity
Kerman Neurocience Research Center
Country
Iran (Islamic Republic of)
Phone
+98 34 1223 5011
Email address
skaramuzian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Neuroscience Center
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two different methods of epidural steroid injection after recurrent lubmar disc herniation
Public title
The effects of epidural steroid injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recurrent disc herniation who do not respond to conventional treatment, radicular pain is greater than lumbar pain, 6 weeks past from pain onset
Exclusion criteria: severe extruded intervertebral disc, progressive neurological deficit, history of steroid injection for lumbar or radicular pain, financial or complaint gain, history of coagulopathy or allergy to anesthetic agent or corticosteroid, pregnancy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
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
Ethic committee of Neuroscience Research Center
Street address
Tahmasbabad cross-road, Jahad street,
City
Kerman
Postal code
Approval date
2010-05-04, 1389/02/14
Ethics committee reference number
کا-ع/3-89
Health conditions studied
1
Description of health condition studied
recurrent lumbar discopathy
ICD-10 code
G55.1
ICD-10 code description
nerve root and plexus
Primary outcomes
1
Description
severity of pain
Timepoint
1, 2 & 6 months after the intervention
Method of measurement
numerical pain score
2
Description
walking tolerance
Timepoint
1, 2 & 6 months after the intervention
Method of measurement
meter
3
Description
standing tolerance
Timepoint
1, 2 & 6 months after the intervention
Method of measurement
minute
Secondary outcomes
empty
Intervention groups
1
Description
Injection of 40 mg methylprednisolone in epidural sapce of spinal column via caudal method
Category
Treatment - Other
2
Description
Injection of 40 mg methylprednisolone in epidural sapce of spinal column via transforaminal method
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Dr Karamouzian
Street address
Shahid Bahonar hospital, Gharani street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
Dr Vahid Sheybani
Street address
Tahmasb abad crossroad
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Neuroscience Research Center
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
Kerman Neuroscience Research Center
Full name of responsible person
Saeid Karamouzian
Position
Neurosurgeon
Other areas of specialty/work
Street address
Bahonar hospital
City
Kerman
Postal code
Phone
+98 913 341 5316
Fax
Email
karamouzian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahiminejad
Position
Acossiate professor of neurosurgery
Other areas of specialty/work
Street address
Gharanee street
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
aliebrahimi_nr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Shahram Shahsavarani
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1273 3617
Fax
Email
shahram_shahsavarani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)