Comparison of Epidural injection of Methylprednisolon, Bupivacaine, and Normal saline on Management of Chronic Low back Pain due to Iumbar Disc Herniation at a level
Patients after signing written informed are randomly divided into three groups using statistical software. All patients initially admitted to the clinic after pain (see reference, direct or by specialist neurosurgery). Inclusion criteria: primary diagnosis of lumbar radicular pain due to discal hernia (bulging, protrusion) with MRI or CT_Scan result based evidences and age over 18 years old, starting with low back pain in 6 weeks. Exclusion criteria: for whom surgery is indicated; muscle weakness or numbness does not respond to progress or in electrodiagnostic be worse; urinary symptoms such as numbness and tingling or urine. Training will be required for the procedure and then randomly divided into three groups based on performance 28-person under lumbar epidural injection of methylprednisolone or bupivacaine or saline will be
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122625702N1
Registration date:2016-03-24, 1395/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-24, 1395/01/05
Registrant information
Name
Naghi Abeddini
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4324
Email address
abdinin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-10-08, 1394/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Epidural injection of Methylprednisolon, Bupivacaine, and Normal saline on Management of Chronic Low back Pain due to Iumbar Disc Herniation at a level
Public title
Lumbar epidural injections in chronic pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with low back pain; does not respond to rest and medication, systemic therapy.
Exclusion criteria: a history of cerebrovascular accidents and diseases; taking anti psychotic drugs; drug Abuse; patients with spinal stenosis; any bleeding areas prohibited for spinal anesthesia; unwillingness to participate in the study; indication for lumbar disc surgery; the history of back pain due to disc herniation; ; low back pain due to Sacro iliac joint problems or rheumatic diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golghasht Avenue
City
Tabriz
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
TBZMED.REC.1394.703
Health conditions studied
1
Description of health condition studied
Chronic lumbar pain
ICD-10 code
M54.5
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Oswestry disability scale
Timepoint
The end of the first week, second, third, fourth and third month
Method of measurement
Questioning and examination
2
Description
Intensity of pain
Timepoint
The end of the first week, second, third, fourth and third month
Method of measurement
Observation and clinical examination
Secondary outcomes
1
Description
Bleeding
Timepoint
24 hours after intervention
Method of measurement
Clinical examination
2
Description
Dora tear
Timepoint
At the same time injection
Method of measurement
Observation at the time of injection
Intervention groups
1
Description
In the first group would be injected 80 mg of methylprednisolone Preparation of ten cc in volume into the epidural space of .
Category
Treatment - Drugs
2
Description
In the second group of local anesthetic bupivacaine 10 ml 0.5% into the epidural space
Category
Treatment - Drugs
3
Description
In the third group would be injected 10 ml of normal saline solution into epidural space
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Dr. Naghi Abeddini
Street address
Shohada hospital, Parvaz St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hasan Soleymanpour
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Naghi Abeddini
Position
Assistant Professor
Other areas of specialty/work
Street address
Shohada hospital
City
Tabriz
Postal code
Phone
+98 41 3389 3336
Fax
Email
naghi26@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naghi Abeddeni
Position
Assistant Professor
Other areas of specialty/work
Street address
Shohada hospital
City
Tabriz
Postal code
Phone
+98 41 3389 3316
Fax
+98 41 3389 3311
Email
abdinin@tbzmed.ac.ir; naghi26@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naghi Abeddini
Position
Assistant Professor
Other areas of specialty/work
Street address
Shohada hospital
City
Tabriz
Postal code
Phone
+98 41 3389 3336
Fax
+98 41 3389 3336
Email
abdinin@tbzmed.ac.ir; naghi26@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)