To find out the effect of Methylprednisolone on disc herniation for patients refffering to Imam Khomeini Hospital
Design
Two arm parallel group non randomized trial of 90 patients on phase 2-3
Settings and conduct
Methylprednisolone Sodium Succinate 500 mg pulse in 500 cc of Normal Saline intravenous infusion injection as a single dose for test group in injection site of Emam Khomeini Hospital's neurosurgery clinic . control group will recieve no corticosteroid as pain killer . Patients's pain will be measured and recorded verbally and visually in first week and then monthly untill 6 months
Participants/Inclusion and exclusion criteria
Patients above 18 with lumbar disc herniation visible in MRI and associated with low back pain radiating to lower limb that is lasting 6 months at least and there is no focal neurlogical defect
Intervention groups
Methylprednisolone Sodium Succinate 500 mg pulse in 500 cc of Normal Saline intravenous infusion injection as a single dose for test group in injection site of clinic and control group will recieve no corticosteroid as pain killer but otc ones . patients are advise to rest in bed for 24h and the patients's pain will be measured and recorded verbally and visually in first week and then monthly untill 6 months
Main outcome variables
low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211116053077N1
Registration date:2022-01-30, 1400/11/10
Registration timing:prospective
Last update:2022-01-30, 1400/11/10
Update count:0
Registration date
2022-01-30, 1400/11/10
Registrant information
Name
mohammad Abiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
mohammadabiri7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-01, 1400/11/12
Expected recruitment end date
2022-03-03, 1400/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Intravenous Infusion of Methylprednisolone 500 mg pulse with NSAIDs in lumbar disc herniation pain relief
Public title
The effect of methylprednisolone pulse in patients with lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lumbar disc herniation visible in MRI
Age above 18
History of low back pain radiating to lower limb in last 6 months
Filling out informed consent form
Exclusion criteria:
Age under 18
Focal neurologic disorders existence
History of vertebral surgery
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not 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 Ilam University of Medical Sciences
Street address
Ilam - Bangangab - Research Blvd.
City
ilam
Province
Ilam
Postal code
6939177143
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.MEDILAM.REC.1400.152
Health conditions studied
1
Description of health condition studied
Intervertebral disc disorders with radiculopathy, lumbar region
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Evaluation of pain relief in patients
Timepoint
The patient's condition is assessed one week after treatment, two weeks, three weeks, and one month and six months after treatment.
Method of measurement
MRI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methylprednisolone Sodium Succinate 500 mg (Lyomedrol EXIR) pulse in 500 cc of Normal Saline intravenous infusion injection as a single dose in 1 hour for test group . Patients will be advised to rest in bed for 24h and avoid heavy physical activities . patients will be taught wilson exercises to relieve their pain
Category
Treatment - Drugs
2
Description
Control group: There will be prescribed oral Diclofenac Sodium 100 mg (Alfen XL Alborz Darou) daily and Patients will be advised to rest in bed for 24h and avoid heavy physical activities . patients will be taught wilson exercises to relieve their pain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Abiri
Street address
Ilam - Bangangab - Research Blvd.
City
ILAM
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7148
Email
Mohammadabiri7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Reza Kafashian
Street address
Pajuhesh Blvd. Ilam university of Medical sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Abiri
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pajuhesh Blvd. Ilam university of medical sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
Mohammadabiri7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoud Hatefi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Pajuhesh Blvd. Ilam university of medical sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
hatefimasoud@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Abiri
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pajuhesh Blvd. Ilam university of medical sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
Mohammadabiri7@gmail.com
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