The objective of this randomized, double blind trial is to investigate the effect of epidural injection of glucocorticoid and glucocorticoid combined with bupivacaine in palliating chronic backache caused by discopathy. In this study, 40 patients with chronic backache who meet the inclusion/exclusion criteria will be recruited and randomly assigned into two groups. In one group, methyl prednisolone 80 mg will be administered via epidural injection. In the second group, in addition to methyl prednisolon 80 mg, bupivacaine 20 mg will also be blended and injected via epidural route in one syringe. Pain intensity, Oswestry disability index, and straight leg rising test will be measured at the baseline and 1 week, 2 weeks, 1 month to three month, and 6 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108137313N1
Registration date:2011-11-07, 1390/08/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-11-07, 1390/08/16
Registrant information
Name
Mirmohammadtaghi Mortazavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 1953
Email address
mortazavimt@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of epidural injection of glucocorticoid and glucocorticoid combined with bupivacaine in palliating chronic low back pain due to discopathy
Public title
The effects of epidural injection of glucocorticoid and glucocorticoid combined with bupivacaine in palliating chronic low back pain due to discopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic backache due to pure discogenic pain, signs of disk degeneration or herniation in MRI in the range of bulging to protrusion without motor and DTR involvement, Induction for epidural injection of glucocorticoid
Exclusion criteria: Chronic backache less than 3 months, Previous surgery or the spinal column, Signs and symptoms of cauda equine, canal stenosis and psychosomatic disorders, drug addiction, receiving any medical treatment
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Golgasht Ave., Tabriz , I.R.IRAN
City
Tabriz
Postal code
51665118
Approval date
2011-07-25, 1390/05/03
Ethics committee reference number
9038
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
G54.4
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
Description
pain severity
Timepoint
1 week, 2 weeks, 1 month to three months and 6 months
Method of measurement
pain free, mild, moderate, severe
2
Description
Straight leg rising test
Timepoint
1 week, 2 weeks, 1 month to three months and 6 months
Method of measurement
Posetive (less than 60 degrees) and negative (more than 60 degrees) and also clinical examination variables.
Secondary outcomes
1
Description
Return to normal activities, social and economic
Timepoint
1 week, 2 weeks, 1 month to three months and 6 months
Method of measurement
The question from patients
Intervention groups
1
Description
methyl prednisolone, 80 mg via epidural injection
Category
Treatment - Drugs
2
Description
methyl prednisolon, 80 mg, as well as bupivacaine 20 mg, injected via epidural route in one syringe
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pain clinic of shohada hospital
Full name of responsible person
Dr. Mortazavi
Street address
Hospital shohada
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
DR.mortazavi
Street address
Shohada Hospital
City
Tabriz
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, 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
Reza Janmardi
Position
Assistant of anesthesia
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Department of anesthesiology
City
Tabriz
Postal code
5165687386
Phone
+98 41 1286 8237
Fax
Email
Reza_janmardi@yahoo.cm
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shohada Hospital
Full name of responsible person
Dr. Mortazavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shohada Hospital
City
Tabriz
Postal code
51678846171
Phone
+98 41 1443 2150
Fax
Email
mortazavimt@yahoo.commortazavim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 914 114 4266
Fax
Email
mortazavimmt@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)