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Comparison of the Effect of Epidural Corticosteroid Injection on Obese and Non-Obese Patients with Lumbar Disc Herniation

Protocol summary

Study aim
Comparison of the Effect of Epidural Corticosteroid Injection on Obese and Non-Obese Patients with Lumbar Disc Herniation
Design
Clinical trial without control group, 150 patients sample size, Trial phase 2-3
Settings and conduct
Tertiary regional and teaching hospital. Participants including major eligibility criteria, among the patients who were candidates for epidural steroid injection in the intraleminal method referred to the Akhtar Hospital in 2018, 150 were selected by Sequential method. Epidural injection of steroid is done by intralaminal method under fluoroscopic guidance at the pathology level. Main outcome measures (variables): Pain Level; disability.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years of age; Symptomatic Disc Hernia; Bilateral radiculopathy; Lumbar Disc disease; Patients with epidural injection Steroid. Exclusion criteria: Degenerative Disc Herniation; Presence of more than two herniated discs at different levels of lumbar; Local skin infections in the area of operation; Deformity of the Spine ; History of Lumbar Spine Surgery; Vertebral fracture; Tumor or Infection in the Spine; Inflammatory Spondylopathy; Neurological defects.
Intervention groups
Epidural steroid injection with 2 ml bupivacaine 2% and 6 ml distilled water and triamcinolone 40 mg / ml (total volume 8 ml)
Main outcome variables
Pain Level; disability.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131124015515N3
Registration date: 2018-12-08, 1397/09/17
Registration timing: registered_while_recruiting

Last update: 2018-12-08, 1397/09/17
Update count: 0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Epidural Corticosteroid Injection on Obese and Non-Obese Patients with Lumbar Disc Herniation
Public title
Effect of Corticosteroid injection in Epidural Space in patients with Lumbar Disc Herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years Hernia disc and in case of stenosis of spinal cord involvement less than 30% based on clinical examinations and CT scan/MRI findings Symptomatic hernia, leg pain and unilateral radiculopathy Lumbar Disc Patients are candidates for epidural steroid injection Signed written informed consent to participate in the study
Exclusion criteria:
Body Mass Index <20 kg/m2 Disc herniation at levels other than L4 to S1 Central hernia with extrusion pain or symptoms of progressive or severe sensory impairment More than two hernia discs at different levels of the lumbar History of steroid epidural injection in the last six months History of opioid abuse The latest use of long-acting opioids with radicular pain for more than a year Coagulation disorders, Steroid susceptibility, Malignancy Psychiatric problems and patient's lack of cooperation, speech problems Surgical indication, local skin infections in the area of operation, deformity of the spine and pregnancy History of lumbar spine surgery, cauda equina syndrome, vertebral fracture, tumor or infection in the spine, inflammatory spondylopathy, neurological defects
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Actual sample size reached: 124
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Bone and Joint Diseases Research Centerو Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.508

Health conditions studied

1

Description of health condition studied
Hernia Disc Lumbar with radiculopathy
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region.

Primary outcomes

1

Description
Pain Level
Timepoint
Before treatment, two, and six weeks after treatment
Method of measurement
visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe)

2

Description
Disability Level
Timepoint
Before treatment, two, and six weeks after treatment
Method of measurement
Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Epidural steroid injection with 2 ml bupivacaine 2% and 6 ml distilled water and 40 mg / ml triamcinolone (total volume 8 ml) in the target area.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Pain Clinic, Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Fax
+98 21 2260 8246
Email
dr.hashemi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi MD.
Street address
Shahid Arabi st., Yaman St., Shahid Chamran Expressway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Masoud Hashemi MD.
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
Dr.hashemi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Masoud Hashemi MD.
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
Dr.hashemi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Masoud Hashemi MD.
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
Dr.hashemi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
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
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