Evaluation of the patients with chronic cervical radiculopathy treated with epidural injection based on MRI and JOACMEQ scoring system
Design
There is a single group in this study. The sample size includes all patients who enter within two months of the start of the project (at least 30patients).
Settings and conduct
Patients failed to respond to maintenance treatment for a month or more are referred to pain ward through a neurosurgeon. Informed written consent is obtained from all patients. Cervical disc classification based on MRI, pain assessment through NRC and VAS, and JOACMEQ rank are evaluated. Then patients undergo epidural injection. One month after the injection, NRC and VAS and the JOACMEQ rating will be reevaluated. The side effects of using epidural steroids will be recorded. The Outcome will be presented after the evaluation of the results.
Participants/Inclusion and exclusion criteria
inclusion criteria: History of unilateral upper extremity radicular pain due to cervical intervertebral disc herniation (confirmed by MRI). Failure to respond to maintenance therapies (such as physical therapy, exercise, and medication) in the past six months.Exclusion Criteria: Coagulation disorder. Sensory and motor disorders in the upper limbs. Needle entry site infection. Degenerative spondylolysis. History of mental illness. History of adverse reactions to steroids or local anesthetics,. History of neck surgery. History of drug abuse
Intervention groups
Patients with cervical radiculopathy referred to Imam Hossein Hospital, Tehran within two months of the start of this research who have not been treated with maintenance therapies eg. physical therapy, exercise and medication in the past six months, if desired to be treated with epidural injection and will enter this study upon their consent. No control group
Main outcome variables
Pain; Quality of life
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20130518013364N10
Registration date:2022-04-12, 1401/01/23
Registration timing:registered_while_recruiting
Last update:2022-04-12, 1401/01/23
Update count:0
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Efficacy of Epidural Injection in Patients With Cervical Radiculopathy Based on MRI Imaging
Public title
Evaluation of The Efficacy of Epidural Injection in Patients With Cervical Radiculopathy Based on MRI Imaging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
History of unilateral upper limb radicular pain due to cervical intervertebral disc herniation confirmed by MRI imaging
Failure in responding to maintenance therapies such as physical therapy, exercise, and medication in the past six months
Exclusion criteria:
Coagulation disorder5. 6. 7. 8. History of mental illness9. Patients with a, local anesthetics10. History of neck surgery11.
Sensory and motor disorders in the upper limbs
Infection at the site of needle entry
Degenerative spondylolysis
History of adverse reactions to steroids
History of adverse reactions to local anesthetics
History of neck surgery
History of drug abuse
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.865
Health conditions studied
1
Description of health condition studied
Cervical radiculopathy
ICD-10 code
M50.1
ICD-10 code description
Cervical disc disorder with radiculopathy
Primary outcomes
1
Description
pain
Timepoint
At the beginning of the study ie. before the epidural injection and one month after the epidural injection
Method of measurement
Visual Analogue Scale
2
Description
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) score
Timepoint
At the beginning of the study ie. before the epidural injection and one month after the epidural injection
Method of measurement
Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In these patients, the combination of 2 cc of Triamcinolone 80 mg and 3 cc of Ropivacaine and 0.2% plus 3 cc of distilled water with a total volume of 7 cc is prescribed via intralaminar injection of cervical epidural. Amp Triamcinolone is made by Elixir Pharmaceutical Company and Amp Ropivacaine is imported by Sina Pishgam Daroo Novin the product of Bioindustria Laboratorio Italiano Medicinali S.p.A
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pain Clinic, Imam Hossein Hospital
Full name of responsible person
Mehrdad Taheri, MD
Street address
Shahid Madani Str
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarqi
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Web page address
https://research.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
Mehrdad Taheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri, MD
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri MD
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
0098 21 7343
Email
m.taheri@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available