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The Comparative study of Effect of caudal & Lumbar Approach in epidural steroides injection in the treatment of acute radicular Low back pain.

Protocol summary

Summary
The aim of this study is to compare caudal and lumbar approach in epidural steroids injection for treatment of acute radicular Low back pain. In a randomized clinical trial, 32 patients with radicular low back pain, aged 20-50 years, and confirmed L5-S1 disk herniation that indicated for non surgical treatment were enrolled and assigned into lumbar or caudal group. Drugs are the same in both group consisting triamsinolon 40 mg, lidocaine 50 mg, and normal saline 10 ml, total volume of 13 ml. In lumbar group, the patients received single injection at L5-S1 space in sitting position but in caudal group, they received an injection at sacral hiatus in lateral position. 30 minute after injection, maximum leg raising was measured and pain intensity was measured 30 min, 1 week, and 1 month after the injection based on the visual analogue scale. Patient’s satisfaction and any possible complication such as headache were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138801181617N2
Registration date: 2010-06-14, 1389/03/24
Registration timing: na

Last update:
Update count: 0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Not enough for processing
Funding source
دانشگاه علوم پزشكی و خدمات بهداشتی درمانی كرمانشاه
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative study of Effect of caudal & Lumbar Approach in epidural steroides injection in the treatment of acute radicular Low back pain.
Public title
The Comparative study of Effect of caudal & Lumbar Approach in epidural steroides injection in the treatment of acute radicular Low back pain: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: radicular low back pain, age 20-50 years, confirmed L5-S1 disk herniation, indication for non surgical treatment Exclusion criteria: bleeding disorders, anticoagulant therapy, local infections, septicemia, hypovolemia, pregnancy, ankylosing spondilitis, low back pain more than 12 month duration, previous spinal surgery, untreated tubercolosis, addiction, spinal tumors, multiple sclerosis, history of diabetes, ASA more than II, unwilling to participate
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
empty
Ethics committee reference number
742028315

Health conditions studied

1

Description of health condition studied
Radiculopathy
ICD-10 code
M54.1
ICD-10 code description
Neuritis or radiculitis

Primary outcomes

1

Description
intensity of pain
Timepoint
30 min,1 week ,and 1 month later
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Triamsinolon 40 mg, lidocaine 50 mg, and normal saline 10 ml, total volume of 13 ml, single injection at L5-S1 space in sitting position
Category
Treatment - Drugs

2

Description
Triamsinolon 40 mg, lidocaine 50 mg, and normal saline 10 ml, total volume of 13 ml, single injection at sacral hiatus in lateral position
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Habiballah khazaie
Street address
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
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
Imam Reza Hospital
Full name of responsible person
Seid Said Hashemi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Imam Reza Hospital,
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoubsaz@kums.ac.ir
Web page address
http://www.kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam reza hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoubsaz@kums.ac.ir
Web page address
http://www.kums.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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