Objectives:
This study is aimed to compare the pain in transforaminal epidural steroid injections and pulsed radiofrequency in patients with chronic radicular low back pain who were referred to Rasul Hospital between 2013-2015 years.
Design:
Randomized clinical trial
Setting and conduct :
Tertiary regional and teaching hospital.
Participants including major eligibility criteria:
Forthy two Patients with chronic radicular low back pain who were referred to Rasul Hospital between 2013-2015 years, were included . Patients were randomized into two groups of 21 each, using a table of random numbers.
Interventions:
control group , patients received, epidural steroid injection method transforaminal interlaminar under fluoroscopic guidance close to the site of the pathology .
Study group , patients received, pulsed radiofrequency in the nerve segment is confirmed with a positive diagnostic block.
Main outcome measures (variables):
Visual analog scale; Oswestry disability index score; Success rate; Patient request for analgesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411037984N22
Registration date:2015-04-06, 1394/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-06, 1394/01/17
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-02-17, 1393/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the pain in transforaminal epidural steroid injections and pulsed radiofrequency in patients with low back pain
Public title
Comparison decrease of the pain in transforaminal epidural steroid injections and pulsed radiofrequency in patients with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria:
Persistent low back pain with or without pain radiating to the upper leg; Age > 18 years old; ASA Class I- II; Lasek test =>50 degrees; Confirming the involvement of nerve roots , vertebral disc protrusion is based on clinical examination and CT scan and MRI findings; Symptoms of chronic low back pain for more than six months; Absence of neurological defects; Absence of epidural injection; Absence of radicular syndrome; No respond to traditional treatments; Positive diagnostic block; Hyperextension pain; No history of lumbar surgery; Contraindication of lumbar surgery; Signing consent to participate in the study.
Main exclusion criteria:
Patients previously treated with radiofrequency; Coagulation disorders; Contrast sensitivity radio- opaque or local anesthetic solution; Malignancy; Psychiatric problems and poor patient cooperation; Speech problems; Pregnancy; Surgery indication; Local skin infection at the operative site; Spinal deformities; Spinal stenosis; Discogenic axial pain; Degenerative disc herniation; Epidural injection of steroids in the past six months; History of opioid abuse; Use of long -acting opioids recent Radicular pain over a year ago; Patients with a history of sensitivity to corticosteroids or contrast material; Inflammatory spondylopathy; Vertebral fracture , tumor , or infection of the spine; No signing consent to participate in the study.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Poursina St.
City
Tehran
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
130/1077/92
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain score
Timepoint
Before the treatment, 24 hours, 1 week, 1 month, 3 months after the treatment
Method of measurement
Visual analog scale
2
Description
Disability measurement
Timepoint
Before the treatment, 24 hours, 1 week, 1 month, 3 months after the treatment
Method of measurement
Oswestry disability index score
3
Description
Successful treatment rate
Timepoint
3 months after the treatment
Method of measurement
Pain relief more than 50%
4
Description
Patient request for analgesia
Timepoint
Before the treatment, 24 hours, 1 week, 1 month, 3 months after the treatment
Method of measurement
Based on the patient's request
Secondary outcomes
empty
Intervention groups
1
Description
In the study group, Pulsed radiofrequency
Category
Rehabilitation
2
Description
In the control group, Transforaminal epidural steroid injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Hospital
Full name of responsible person
Farnad Imani MD.
Street address
Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh MD.
Street address
Poursina St.
City
Tehran
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, Tehran 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
Rasul Hospital
Full name of responsible person
Farnad Imani MD.
Position
Associate professor
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
farimani@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Farnad Imani MD.
Position
Associate professor
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
farimani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Farnad Imani MD.
Position
Associate professor
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
farimani@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)