A comparison of the effect of anti-fatigue floor mat and viscoelastic shoe insole on preventing of low back pain due to prolonged standing in healthy subjects: An interventional study
Objectives: The aim of this interventional study was to comparison the effect of anti-fatigue floor mat and viscoelastic shoe insole on electrical activities of the bilateral gluteus medius muscles and subjective low back pain (LBP) over prolonged standing.
Design: 15 healthy participants with no history of LBP and without knowing the type of floor mats and shoe insoles were recruited to stand for 2 hours in four different standing positions which include; standing on the hard floor; standing on the anti-fatigue floor mat; using a placebo shoe insole while standing on the hard floor and the use of viscoelastic shoe insole while standing on the anti-fatigue floor mat. The interval period between the four trials for each participant was at least 7 days.
Setting and conduct: In each position, at the beginning of the 2 hours standing protocol and at every 15 minutes during 2 hours standing, electrical activities of the gluteus medius muscles were collected by continuous surface electromyography (EMG), for analysis of bilateral coactivation pattern. Subjective LBP over standing time also were collected by visual analogue scale (VAS).
Participants: 15 healthy participants with no history of LBP and ability to stand for more than 4 hours were recruited.
Interventions: In the present study, anti-fatigue floor mat and viscoelastic shoe insole as intervention were applied.
Main outcome measures: Pattern of bilateral gluteus medius muscles coactivation and subjective LBP.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016122430546N2
Registration date:2017-01-20, 1395/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Iraj Mohebbi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3193 7224
Email address
irajmohebbi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-04-04, 1392/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of anti-fatigue floor mat and viscoelastic shoe insole on preventing of low back pain due to prolonged standing in healthy subjects: An interventional study
Public title
A comparison of the effect of floor mat and shoe insole on low back pain due to prolonged standing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Consent to participate in the study; the lack of any history of low back pain (LBP) requiring medical intervention or more than 3 days sick absence; any history of LBP over the past 12 months; no previous hip surgery; ability to stand for more than 4 hours; not having any kind of occupation requiring static standing over the past 12 months.
Exclusion criteria: The lack of consent to participate in the study; having any history of LBP requiring medical intervention or more than 3 days sick absence; having any history of LBP over the past 12 months; having previous hip surgery; the lack of ability to stand for more than 4 hours; having any kind of occupation requiring static standing over the past 12 months.
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
جلسه شماره 105؛ تاریخ 91.12.15؛ بند 10 صورتجلسه
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
Gluteus medius muscles co activation
Timepoint
Every 15 minutes during 2 hours standing
Method of measurement
Electromyography
2
Description
Subjective pain
Timepoint
Every 15 minutes during 2 hours standing
Method of measurement
Visual analogus scales
Secondary outcomes
empty
Intervention groups
1
Description
The use of anti-fatigue floor mat while standing.
Participants were instructed to stand in their usual manner, do not take any step, and do not lean on the table to rest their feet and to support their body weight.
Category
Prevention
2
Description
The use of viscoelastic shoe insole while standing on a hard floor.
Participants were instructed to stand in their usual manner, do not take any step, and do not lean on the table to rest their feet and to support their body weight.
Category
Prevention
3
Description
The use of viscoelastic shoe insole while standing on the anti-fatigue floor mat.
Participants were instructed to stand in their usual manner, do not take any step, and do not lean on the table to rest their feet and to support their body weight.
Category
Prevention
4
Description
Using a placebo shoe insole while standing on a hard floor.
Participants were instructed to stand in their usual manner, do not take any step, and do not lean on the table to rest their feet and to support their body weight.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Vice chancellor for research of Urmia University of Medical Sciences, Urmia University of Medical Sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Mahmoud Ghaderi
Position
Research assistant/ MSc
Other areas of specialty/work
Street address
Urmia University of Medical Sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
ghaderi_mahmoud@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Position
Vice president of Research and Technology/ MD
Other areas of specialty/work
Street address
Urmia University of medical sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
irajmohebbi@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Mahmoud Ghaderi
Position
MSc/ Research assistant
Other areas of specialty/work
Street address
Urmia University of Medical Sciences Central Site, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
ghaderi_mahmoud@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)