Comparing the effect of epidural steroid injection with mixture of steroid and calcitonin in lumbosacral canal stenosis patients.
Design
Thirty four patients with history of low back pain originating from lumbar canal stenosis are selected. They didn't respond to conservative management for 6 months and are randomly(block randomization) divided to two groups: one group receives 80 mg methyl prednisolon and 4 cc marcaine via epidural under fluoroscopic guide while second group receives 80 mg methyl prednisolon , 4 cc marcaine and 100 units calcitonin plus recommendation for life style modification and exercise for two groups. On weeks 0,2,4 and 8 all patients complete the VAS, OSWESTRY AND QUEBEC questionnaires.
Settings and conduct
Chamran hospital , Shiraz, Fars , Iran
Study will be double blind. Patients and outcome assessors will not be informed about type of injected drugs.
Participants/Inclusion and exclusion criteria
inclusion criteria:
complete and sign the informed consent form , pain and other symptoms of lumbosacral spinal stenosis don't respond to coseravative management for 6 months, age between 45 to 75
Exclusion criteria: 1.Simultaneous radiculopathy 2.Diabetes mellitus 3.Rheumatologic disease such as collagen vascular disease , SLE , gout 4.Simultaneous neuropathy 5.Brucella infection 6.BMI> 42 7.Knee arthroplasty in affected side 8.Coaglopathy 9.Allergy to medication 10.Hepatic , renal or cardiac failure 11.Cancer 12.Pregnancy 13.Inability to complete questionnaire and poor cooperation
Intervention groups
Group A receives 80 mg methyl prednisolon and 4 cc marcaine via epidural under fluoroscopic guide while group B receives 80 mg methyl prednisolon , 4 cc Marcaine and 100 units Calcitonin plus recommendation for life style modification and exercise for two groups.
Main outcome variables
pain reduction , functional improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171112037419N1
Registration date:2017-12-26, 1396/10/05
Registration timing:registered_while_recruiting
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Razieh pirzad
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 32319040
Email address
am_ebrpoor@me.iut.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research in Shiraz university of medical sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of epidural steroid injection with mixture of steroid and calcitonin in lumbosacral canal stenosis patients.
Public title
Injection for lumbar canal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lumbar pain nonresponsive to conservative management for 6 months
Between 45-75 y/o
Completing and signing informed consent form
Exclusion criteria:
Diabetes Mellitus
Rhematoid arthritis,collagen vascular disease,gout, lupus
Simultaneous lumbar radiculopathy or neuropathy
Bruclla infection
BMI>42
Knee or hip arthroplasty
Bleeding tendencies and disorders
Impaired cognition
Drug allergy
Liver,renal,pulmonary or cardiac problem
Pregnancy
Cancer
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Randomization unit: individual
by statistical software
A list with even block height is provided and the secretor divides the patient according to the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and researcher dont know about type of injected drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Zand avenue,Shiraz university of medical sciences building.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-11-07, 1396/08/16
Ethics committee reference number
IR.SUMS.MED.REC.1396.92
Health conditions studied
1
Description of health condition studied
lumbosacral spinal stenosis
ICD-10 code
M48.06
ICD-10 code description
SPINAL STENOSIS ,LUMBAR REGION
Primary outcomes
1
Description
pain
Timepoint
2 months
Method of measurement
VAS,OSWESTRY,Quebec questionnaires
Secondary outcomes
1
Description
functional class and quality of life improvement,decreased oral medication consumption
Timepoint
2 months
Method of measurement
VAS,OSWESTRY,QUEBEC questionnaires
Intervention groups
1
Description
control group:80 mg methyl prednisolon and 4 cc marcaine epidural injection plus education of life style modification and exercise
Category
Treatment - Drugs
2
Description
intervention group:80 mg methyl prednisolon , 4 cc marcaine and 100 units calcitonin epidural injection plus education of life style modification and exercise
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Hamid Reza Farpour
Street address
Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Email
am_ebrpoor@me.iut.ac.ir
2
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Hamid Reza Farpour
Street address
Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Email
am_ebrpoor@me.iut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpour
Street address
Zand Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Email
am_ebrpoor@me.iut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpour
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand avenue,Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Fax
Email
farporh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpour
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand avenue,Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Fax
Email
farporh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Razie pirzad
Position
physical medicine and rehabilitation student
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Zand avenue,Shiraz university of medical sciences
City
SHIRAZ
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Fax
Email
am.ebrpoor@me.iut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available