Objectives : The aim of this study is to assess the effect of lumbosacral support on postural control strategies and sensory integration in low back pain. Design: simple non-randomised control trial. Participants: In this study 30 young volunteer participate in each group ( a group of chronic low back pain and a control group ). Including major eligibility: low back pain patients had no other medical problem and at least 6 mounth pain history. The low back pain is non-spesific type with unknown specific pathology. The pain intensity is less than 3/10 based on visual analog scale. Intervention: Different trials will be done in two main conditions: 1) with lumbosacral support 2) without lumbosacral support. Setting and conduct: Subjects stand on force plate barefoot , arms hanging on both sides in such a way that their heels distance is 10 cm. each subject does 4 trials and each trial lasting 75 second in both conditions, in order to Main outcome measures: center of pressure(COP) linear ( anterior-posterior and lateral COP displacement ,COP mean velocity , COP area) and non-linear ( entropy ) analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020326346N1
Registration date:2016-05-23, 1395/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Gholamreza Olyaei
Name of organization / entity
Tehran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8469
Email address
olyaeigh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lumbosacral support on postural control strategies and sensory integration in low back pain
Public title
Immediate effect of lumbosacral support on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
]ncluding major eligibility: subjects with chronic low back pain؛ no history of another muscoloskeletal disorder؛ no history of cardio - respiratory disorder؛ no history of surgery؛ non professional athlete
Exclusion major eligibility: subject wouldn't be continue protocol؛ subject's disability in test؛ increase pain intensity or induced each comfort during test protocol؛ inappropriate force plate's signal recording؛ hyperlordosis in lumbar
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethic Committee Of Tehran University Of Medical Sciences
Street address
Pour Sina St, District 6, Tehran
City
Tehran
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.TUMS.REC.1394.2145
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
anterior - posterior COP maximum displacement
Timepoint
befor wear lumbosacral support - during wear lumbosacral support
Method of measurement
force plate - milimeter
2
Description
lateral COP mnaximum displacement
Timepoint
befor wear lumbosacral support - during wear lumbosacral support
Method of measurement
force plate - milimeter
3
Description
mean COP velocity
Timepoint
befor wear lumbosacral support - during wear lumbosacral support
Method of measurement
force plate - mm/s
4
Description
COP area
Timepoint
befor wear lumbosacral support - during wear lumbosacral support
Method of measurement
force plate - mm2
5
Description
Approximate - Entropy
Timepoint
befor wear lumbosacral support - during wear lumbosacral support
Method of measurement
ApEp(m,r,n)=Өm-Өm-1
Secondary outcomes
1
Description
pain
Timepoint
befor and immediatly after test
Method of measurement
visual analog scale
Intervention groups
1
Description
wearing lumbosacral support in low back pain patient
Category
Treatment - Other
2
Description
wearing lumbosacral support in healthy control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University Of Medical Sciences School Of Rehabilitation
Full name of responsible person
Masoud Ghofrani, PHD Candidate
Street address
School Of Rehabilitation, Piche Shemroon, Enghelab street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Tehran 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
Tehran University of Medical Sciences, School Of Rehabilitation
Full name of responsible person
Dr Gholamreza Olyaei
Position
Professor
Other areas of specialty/work
Street address
School Of Rehabilitation, Piche Shemroon, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 7752 8469
Fax
Email
olyaeigh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr Gholamreza Olyaei
Position
Professor
Other areas of specialty/work
Street address
School Of Rehabilitation, Piche Shemroon, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 7752 8469
Fax
Email
olyaeigh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences, School Of Rehabilitation
Full name of responsible person
Masoud Ghofrani
Position
Physicaltherapy PHD student
Other areas of specialty/work
Street address
School of Rehabilitation, Piche Shemroon, Enghelab Street, Tehran
City
Tehran
Postal code
Phone
+98 21 7752 8469
Fax
Email
masood.ghofrani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)