Compare the effect of corrective exercise training and ergonomics education on service forces and care aids with low back pain
Design
Randomized trial with community based and pragmatic control group, with parallel groups, one-way blind
Settings and conduct
The present study in Isfahan hospitals will be face-to-face for each person and blind on one side and the data analyst will be unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Employment in Hospitals in Isfahan
Have at least reading and writing skills
Having a back pain in more than three months
Present written consent for participation in the research
Non-Inclusion criteria:
Specific low back pain such as infection, rheumatoid diseases, congenital anomalies, history of cancer according to history and health
Having a history of vertebral surgery, spinal tumor, history of spinal fracture and multiple sclerosis
Having a health ban to do sports exercises
Intervention groups
The corrective exercises for 8 weeks, 3 sessions 40 to 60 minutes a week, will include 5 to 10 minutes of general warm-up, 20 to 40 minutes of tensile and reinforcement training and 5-10 minutes of cooldown. The ergonomic intervention group will receive 8 weeks of interventions based on the Ministry of Labor and Health regulations on the state of the body and body movements. By avoiding unnecessary or excessive stresses on the muscles, joints, ligaments, respiratory system and cardiovascular system. The exact details of the exercise program and ergonomic intervention will be presented in an educational pamphlet and will be delivered to any assistant and service personnel and will be faced with the delivery of face-to-face training. The control group will not receive any intervention.
Main outcome variables
The amount of pain and disability in people with low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N4
Registration date:2018-12-19, 1397/09/28
Registration timing:registered_while_recruiting
Last update:2018-12-19, 1397/09/28
Update count:0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of corrective exercise training and ergonomics education on service forces and care aids with low back pain
Public title
The effect of corrective exercise training and ergonomics education on service forces with low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Employment in Al-Zahra, Kashani and Khorshid Hospitals in Isfahan
Have at least reading and writing skills
Having a back pain in more than three months
Present written consent for participation in the research
Exclusion criteria:
Specific low back pain such as infection, rheumatoid diseases, congenital anomalies, history of cancer according to history and health
Having a history of vertebral surgery, spinal tumor, history of spinal fracture and multiple sclerosis
Having a health ban to do sports exercises
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Assistants and Service Providers will be selected by easy and accessible sampling method according to the entry and exit criteria, so that sample size reaches 75, then using computer encoding into groups of 25, including receiving group Corrective exercises, the group receiving the ergonomic interventions and the control group will be divided.
Blinding (investigator's opinion)
Single blinded
Blinding description
Information will be available to the data analyst after naming and naming.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, HezarJereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.MUI.MED.REC.1397.144
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Compare the effect of corrective exercise training and ergonomics education on service forces and care aids with low back pain Using the Visual Analogue Scale (VAS)
Timepoint
Before and after intervention and eight weeks after the end of intervention, in each of the three groups, the pain intensity was measured using VAS pain scale.
Method of measurement
Using a 10-point VAS pain scale, this scale indicates zero pain and the number 10 indicates a high pain.
2
Description
The Effect of Rehabilitation Exercise Training and Training on the Principles of Ergonomics in Helping Surveyors and Service Persons with Back Pain by Using the Ossourist Disability Questionnaire
Timepoint
Before the intervention and eight weeks after the intervention, all of the three groups will be asked about the disability by using the osoestory disability inventory questionnaire.
Method of measurement
The Osustory Disability Questionnaire was questioned and evaluated in 10 sections (each section containing 6 questions) including pain intensity, personal work, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and travel. Gives.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: corrective exercise training will be received in this group for 8 weeks, weekly 3 sessions and 40-60 minutes each session. Each training session includes 5 to 10 minutes of general warm-up, 20 to 40 minutes of specialized training (tensile and reinforcement training) and 5-10 minutes of cooing. The exact details of the exercise program are presented in a pamphlet (localized based on the work environment) and will be delivered to any assistance and service personnel and will face face-to-face delivery.
Category
Rehabilitation
2
Description
Intervention group: Ergonomics education that will receive their interventions for 8 weeks based on the health and safety regulations of the Ministry of Labor on the state of the body and body movements. By avoiding unnecessary or excessive stresses on the muscles, joints, ligaments, respiratory system and cardiovascular system. In this group, detailed details of the ergonomic intervention will be presented in a pamphlet (localized based on the work environment) and will be delivered to any assistance and service personnel and will face face-to-face delivery.
Category
Rehabilitation
3
Description
Control group: this group will not receive special intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Alireza Safaeian
Street address
Al Zahra Hospital, Sufeh Street.
City
Isfahan
Province
Isfehan
Postal code
81747-73461
Phone
+98 31 3668 0048
Email
Ar.Safaeian@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Isfahan Khorshid Hospital
Full name of responsible person
Alireza Safaeian
Street address
Ostandari Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3222 2127
Email
Ar.Safaeian@med.mui.ac.ir
3
Recruitment center
Name of recruitment center
Isfahan Ayatollah Kashani Hospital
Full name of responsible person
Alireza Safaeian
Street address
Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3233 0019
Email
Ar.Safaeian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Research Assistant, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8134
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Safaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, HezarJereyb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Ar.Safaeian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Safaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Ar.Safaeian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Safaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Ar.Safaeian@med.mui.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information can be given to the applicants after being unidentifiable and can be dismissed by the research deputy of Isfahan University of Medical Sciences.
When the data will become available and for how long
Information is available two years after the publication of the results.
To whom data/document is available
Researchers in Rehabilitation Sciences, Physical Medicine and Social Medicine can benefit from the results of this study.
Under which criteria data/document could be used
In case of using similar supportive and therapeutic methods in patients with low back pain and comparing with current methods.
From where data/document is obtainable
After sending an email to Ar.Safaeian@med.mui.ac.ir and obtaining permission from the research deputy of the Isfahan University of Medical Sciences, information is available.
What processes are involved for a request to access data/document
Send an email to Ar.Safaeian@med.mui.ac.ir and get permission from the Vice-Chancellor of Research in Isfahan University of Medical Sciences