Investigation of the effect of training lumbar stabilization exercise training on the severity of low back pain in pre-hospital emergency personnel
Design
Clinical trial with a control group, with parallel groups, randomized, on 50 patients (2 groups of 25 people). Excel software rand function was used for randomization.
Settings and conduct
Amol pre-hospital emergency
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least one year of work experience; Existence of low back pain intensity 4 or higher on NRS scale; No history of back and spine trauma; Absence of abnormalities in the spine and inflammatory disease; Age 25-65 years.
Exclusion criteria: Do not do exercises for more than two consecutive sessions; Body mass index more than 30 kg per square meter; Taking narcotics drugs to relieve pain; Surgery during the intervention.
Intervention groups
Intervention group: In this group, participants are asked to perform low back pain stabilization exercises designed by researchers for 6 weeks on a regular basis and a day in between for 20 minutes.
Control group: There is no intervention and it is only for comparison with the intervention group.
Main outcome variables
Back pain intensity; Disability intensity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N59
Registration date:2020-10-26, 1399/08/05
Registration timing:registered_while_recruiting
Last update:2020-10-26, 1399/08/05
Update count:0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of training lumbar stabilization exercise training on the severity of low back pain in pre-hospital emergency personnel
Public title
Investigation of the effect of training lumbar stabilization exercise training on the severity of low back pain in pre-hospital emergency personnel
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year of work experience
Existence of low back pain intensity 4 or higher on NRS scale
No history of back and spine trauma
Absence of abnormalities in the spine and inflammatory disease
Age 25-65 years
Exclusion criteria:
Do not do exercises for more than two consecutive sessions
Body mass index more than 30 kg per square meter
Taking narcotics drugs to relieve pain
Surgery during the intervention
Age
From 25 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 25 members using block randomization with block sizes of 2.
Randomized permutation blocks (block 2).
Excel software rand function was used for randomization.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SEMUMS.REC.1399.171
Health conditions studied
1
Description of health condition studied
Lumbago
ICD-10 code
M54.4
ICD-10 code description
Lumbago with sciatica
Primary outcomes
1
Description
Back pain intensity
Timepoint
Before and after the intervention
Method of measurement
Numeric Rating Scale for Pain (NRS Pain)
2
Description
Disability intensity
Timepoint
Before and after the intervention
Method of measurement
Oswestry Disability Questionnaire (ODQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, participants are asked to perform low back pain stabilization exercises designed by researchers for 6 weeks on a regular basis and a day in between for 20 minutes.
Category
Treatment - Other
2
Description
Control group: There is no intervention and it is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Amol pre-hospital emergency
Full name of responsible person
Mohammadreza Asgari
Street address
Amol pre-hospital emergency
City
Amol
Province
Mazandaran
Postal code
3519646592
Phone
+98 11 3234 5689
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Houshang Abbasi Shirsavar
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kowsar Hospital, Amin Street.
City
Semnan
Province
Semnan
Postal code
3514614172
Phone
+98 23 3365 4162
Email
are20935@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