The aim of this study is to investigate the effects of custom made insole and training exercise on post work fatigue and discomfort at low back and lower extremity in assembly line workers in DENA tire company
Design
in this research, 100 assembly line worker and with inclusion criteria and with block randomization divided into 4 group that are 3 intervention group and 1 control gruop.
Settings and conduct
this research will done in Dena rubber company on assembly line workers, insole and exercise training intervention will done, analyser and investigator are blind.
Participants/Inclusion and exclusion criteria
workers who have at least 1 year work record; stand at least for 3 hours a day; haven`t any skeletal disorder in lower extremity.
Intervention groups
The first group will receive custom made insole, the second group will receive custom made insole with exercise,The third group will revive just exercise and the forth is control group
Main outcome variables
fatigue and discomfort in lower extremity
discomfort an be any undesirable sensation such as pain, burn sensation and etc.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033995N1
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Elahe Mousavi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4440 2053
Email address
stud2411580177@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-10-26, 1396/08/04
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
2017-10-26, 1396/08/04
Actual recruitment end date
2017-12-20, 1396/09/29
Trial completion date
empty
Scientific title
compare the effect of custom made insole and training exercise on reduce post-work fatigue and discomfort of the lower extremities in assembly workers
Public title
Effect of custom made insole and training exercise on post-work fatigue and discomfort of the lower extremities and low back after prolonged standing.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Assembly line workers of Dena rubber company
minimum work record 1 year
minimum standing in day 3 hours
Exclusion criteria:
injury in lower extremity include fracture, dislocation or soft tissue injury in 6 month ago
any surgery in lower extremity muscle, bone or joint
muscle skeletal disorder such as RA, myopathy, neuropathy
any deformity in lower extremity such as pes planus, pescavus, halux valgus
vascular disorder in lower exterimity
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization, at first we choose 100 worker between who had inclusion criteria then allocated special number for everyone and blocks wrote base on 4 factorial and according to the list every one put in a special group.
Blinding (investigator's opinion)
Not blinded
Blinding description
investigator and data analyser are blind and don`t know what intervention do for every group .
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, No. 3, Zand Ave., Namazi Blvd.
City
Shiraz
Province
Fars
Postal code
00987132357282
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.SUMS.REC.1395.190
Health conditions studied
1
Description of health condition studied
fatigue and discomfort in lower extremity and low back during prolonged standing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue and Discomfort
Timepoint
before intervention and 8 week after intervention
Method of measurement
with questionnaire of body map and Rating on Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
first intervention group
type of intervention : custom made insole.
duration of intervention: 8 week
Category
Other
2
Description
the second intervention group
type of intervention: custom made insole in their shoes and the exercise
duration of intervention:8 week
Category
Other
3
Description
the third group intervention
type of intervention:training of the exercise
duration of intervention:8 week
Category
Other
4
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
DenaTire Company
Full name of responsible person
Elahe Sadat Mousavi
Street address
Abbas Doran st., Modares blvd., Dena Rubber Company
City
Shiraz
Province
Fars
Postal code
1517973311
Phone
+98 71 3742 0030
Fax
+98 71 3742 0024
Email
Z.nikouei@yahoo.com
Web page address
http://www.denatire.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Zahra Zamanian
Street address
Zand blv, front of palestin Ave
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
vcrdep@sums.ac.ir
Web page address
http://www.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?