Comparative study of quality of life and non surgical and surgical treatment results in patients with lumbar disc herniation
Design
This study is a non-blind clinical trial. The study population will include all patients referred to the Kermanshah Neurology clinic. A total of 100 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study will be conducted in the Kermanshah Neurology clinic is a non-blinded one. At the beginning of the study, the severity of pain, functional disability, and quality of life of patients for both groups are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of lumbar disc herniation by a neurosurgeon; About a month has passed since they became ill; No neurological defects including weakness of limbs and sphincter disorder
Exclusion criteria: Suffering from other diseases including vertebral and spinal tumors, vertebral fractures, inflammatory diseases, mental illness, and trauma;
People with underlying diseases such as orthopedic, heart and respiratory problems; People with lung infection, renal, metabolic disorders, stroke or trauma
Intervention groups
The first intervention group will undergo surgery. The second intervention group receives medical treatments.
Main outcome variables
Quality of life, pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N153
Registration date:2020-07-19, 1399/04/29
Registration timing:prospective
Last update:2020-07-19, 1399/04/29
Update count:0
Registration date
2020-07-19, 1399/04/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of quality of life and non surgical and surgical treatment results in patients with lumbar disc herniation
Public title
comparison of quality of life and non surgical and surgical treatment results in patients with lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of lumbar disc herniation by a neurosurgeon
About a month has passed since they became ill
No neurological defects including weakness of limbs and sphincter disorder
Exclusion criteria:
Suffering from other diseases including vertebral and spinal tumors, vertebral fractures, inflammatory diseases, mental illness and trauma
People with underlying diseases such as orthopedic, heart and respiratory problems
People with lung infection, renal, metabolic disorders, stroke or trauma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the first intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the second intervention group.
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
ir.kums.rec.1397.547
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51
ICD-10 code description
Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders
Primary outcomes
1
Description
Quality of life
Timepoint
Six weeks, three months and one year after starting treatment
Method of measurement
Based on Quality of Life Questionnaire (SF36)
2
Description
pain intensity
Timepoint
Six weeks, three months and one year after starting treatment
Method of measurement
Based on the visual scale of pain (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will undergo surgery
Category
Treatment - Surgery
2
Description
The second intervention group receives medical treatments.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of University of Medical Sciences
Full name of responsible person
Azadeh Asgari
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.asgari26@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Azadeh Asgari
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.asgari26@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Fatahian
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
rfatahian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azadeh Asgari
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.asgari26@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail