Ipsilateral Sacroiliac dysfunction among (Right/Left-hand drive) taxi drivers and effect of sacroiliac belt on muscular activity during sit to unilateral stand task.
1. To find the ipsilateral SIJP among the taxi drivers.
2. To find relation between the driving side and the side of involvement of the SIJP.
3. Predisposing factors causing SIJP in the drivers.
Design
Randomized clinical controlled trial (RCT)
Settings and conduct
600 Taxi drivers from Iran & 600 from Pakistan would be recruited by Simple Random Sampling (SRS).
A valid questionnaire (Oswestry Disability Index- Iranian Version , Roland-Morris Disability Index- Iranian Version, the Quebec Back Pain Disability Scale with an additional self-administered questionnaire having socio-demographic factors, work characteristics and dysfunction explanation, designed for this study would be filled by the researcher while asking the questions regarding low back pain from left hand drive drivers from Iran and the Urdu version of above mentioned questionnaires would be used for right hand drive drivers in Pakistan.
In the second phase of the research. EMG would be performed on the SIJP & healthy group.
Participants/Inclusion and exclusion criteria
Male taxi drivers aged between 20-60 years with work experience of more than one year and willing to cooperate will be included in initial phase of the study. For EMG recording, SIJP of at least 2 months pain in joint, no radiation of pain towards lower limb, diagnosed by 3 positive sacroiliac provocative tests, having no postural dysfunction or limb length discrepancy would be selected. Healthy group for EMG recording would be selected on the basis of no previous pain history in SIJ, having normal active straight leg raising (ASLR) test and with no congenital anomaly.
Intervention groups
Sacroiliac Belt
Main outcome variables
1. Pain
2. Function
3. RMS
4. Muscle Activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090301001722N17
Registration date:2018-02-09, 1396/11/20
Registration timing:registered_while_recruiting
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences- International Campus
Expected recruitment start date
2017-09-15, 1396/06/24
Expected recruitment end date
2018-03-15, 1396/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ipsilateral Sacroiliac dysfunction among (Right/Left-hand drive) taxi drivers and effect of sacroiliac belt on muscular activity during sit to unilateral stand task.
Public title
Ipsilateral Sacroiliac dysfunction among (Right/Left-hand drive) taxi drivers and effect of sacroiliac belt on muscular activity during sit to unilateral stand task.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Male taxi drivers
Aged between 20-60 years
Work experience of more than one year
willing to cooperate
Exclusion criteria:
Having history of surgery
Acute pathological condition
Radiating pain toward lower limb
Any limb length discrepancy
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
2
Right & left sides ( Or healthy & affected in patients) of each individual would be investigated
Randomization (investigator's opinion)
Randomized
Randomization description
The examiner will remain blind about the low back condition who will perform sacroiliac provocative test. During EMG, the investigator will also be bling about the side of involvement of the sacroiliac Joint and low back pain.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner will remain blind about the low back condition who will perform sacroiliac provocative test. During EMG, the investigator will also be bling about the side of involvement of the sacroiliac Joint and low back pain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences (TUMS)
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3443
Health conditions studied
1
Description of health condition studied
Sacroiliac Joint Dysfunction
ICD-10 code
M99.04
ICD-10 code description
Musculoskeletal disorders - Segmental and somatic dysfunction of sacral region
Primary outcomes
1
Description
PAIN
Timepoint
Before & after Treatment ( Immediate effect & Prolong Effect after one month)
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Integrated EMG
Timepoint
Before and after Treatment
Method of measurement
Surface EMG by Biometrics (Ltd) data Log
3
Description
Root mean square (RMS)
Timepoint
Before and after Treatment
Method of measurement
Surface EMG by Biometrics (Ltd) data Log
4
Description
Time to peak
Timepoint
Before and after Treatment
Method of measurement
Surface EMG by Biometrics (Ltd) data Log
5
Description
Duration of the muscle activity
Timepoint
Before and after Treatment
Method of measurement
Surface EMG by Biometrics (Ltd) data Log
6
Description
Premotor Time
Timepoint
Before and after Treatment
Method of measurement
Surface EMG by Biometrics (Ltd) data Log
Secondary outcomes
1
Description
Function
Timepoint
Before and after Treatment
Method of measurement
Modified Oswestry Disability
Intervention groups
1
Description
Intervention group(A): Before Treatment; EMG would be performed on this group before the application of Sacroiliac belt.
Category
Treatment - Other
2
Description
Intervention group(B): After Treatment; EMG would be performed on this group after the application of Sacroiliac belt.
Category
Treatment - Other
3
Description
Control group:Based on methodology, EMG would be performed on this healthy group without performing any treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation,Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad-Reza Hadian Rasanani
Street address
School of Rehabilitation, Tehran University of Medical Sciences. Enghelab Ave. Pich-Shemiran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 8891 3469
Email
hadianrasan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirali Sohrabi
Street address
Tehran University of Medical Sciences Keshavarz Blvd, Kods street Tehran Tehran Iran, Islamic Republic Of 14167
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 8891 3469
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences (TUMS)-International Campus
Full name of responsible person
Dr.Mohammad-Reza Hadian Rasanani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8891 3469
Fax
+98 21 8891 3469
Email
hadianrasan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Reza Hadian
Position
Professor, School of Rehabilitation, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8891 3469
Fax
Email
hadianrs@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Reza Hadian Rasanani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8891 3469
Fax
Email
hadianrasan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
As per consent form, Researcher was obliged to keep the participants information confidential.
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study Protocol: It would be available in the published article & thesis in the library
Statistical Analysis Plan: It would be available in the published article & thesis in the library
Informed Consent Form: It would be available in the thesis in the library
Clinical Study Report: In the form of published articles or report
When the data will become available and for how long
For Ever
To whom data/document is available
For All
Under which criteria data/document could be used
According to the rules of journal and library
From where data/document is obtainable
Journals & Library in the institure
What processes are involved for a request to access data/document