Our aim is to determine any differences in the stride-to-stride fluctuations in LBP patient while wearing lumbosacral orthoses ,i.e, CNS can perceive the passive stiffness provided by lumbosacral orthoses and make any motor control adaptations to this enhancement of spine stability.24 subjects with chronic non specific low back pain will participate in the study. subjects will be randomly allocated to control and intervention groups. The control subjects will receive physical therapy (exercises and electrotherapy) and intervention group will receive physical therapy as well as a semirigid LSO for 6 weeks, 6-8 hour a day.Inclusion criteria will be as patient with chronic non-specific low back pain and pain intensity from 1 to 6 that their pain lasts at least 6 months. Patient with specific low back pain and referral neurological pain to distal of lower limbs and patients who previously used lumbar support will be excluded.
Pain and functional outcomes will be recorded using numerical pain rating scale, Oswestry disability index, and fear avoidance belief questionnaire. The data collection will do at first day of treatment and repeat at 3 weeks and 6 weeks after treatment. Subjects will be followed one month after the end of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072828310N2
Registration date:2016-08-25, 1395/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-08-25, 1395/06/04
Registrant information
Name
Mohammad Ali Sanjari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051 ext. 198
Email address
sanjarima@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lumbosacral orthosis on the gait dynamics in chronic non-specific low back pain patients
Public title
Effect of Lumbosacral orthosis on low back pain management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
Patients with chronic non-specific low back pain; Low back pain intensity from 1 to 6; Low back pain for at least 6 months; There should be acute exacerbation periods of low back pain; 3 months from the last treatment session; Age between 18 to 50 years; Subjects could be able to walk with preferred walking speed for 10 minutes so that pain is not barrier for walking
Exclusion criteria
Specific low back pain such as disk herniation, fracture, spondylolisthesis; Referral pain in the lower limbs; History of spinal surgery; History of trauma resulted in sprain, dislocation and fracture in spinal area; Any surgical intervention in pelvis and lower limbs; Use of any medication that influence walking; Any previous use of lumbar supports
- gait imbalance and use of assistive devices
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The method of randomized number selection will be used for randomized allocation of the groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
IR.IUMS.REC.1394.3.41051230
Health conditions studied
1
Description of health condition studied
Chronic non-specific low back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified , Backache NOS
Primary outcomes
1
Description
pain
Timepoint
before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
Method of measurement
numerical pain rating scale
2
Description
disability
Timepoint
before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
Method of measurement
Oswestry disability index questionnaire
3
Description
fear avoidance
Timepoint
before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
Method of measurement
fear avoidance belief questionnaire
Secondary outcomes
1
Description
Fractal scaling index
Timepoint
before intervention, 3 weeks aftre intervention, 6 weeks after intervention, 1 month after the stop of the intervention
Method of measurement
motion analysis system, power law relationship between stride to stride fluctuations and time as measuring the slope of log/log-fluctuations plot
Intervention groups
1
Description
Intervention group will receive physical therapy (exercises and electrotherapy) as well as a semirigid lumbosacral orthosis for 6 weeks, 8 hour a day.
Category
Rehabilitation
2
Description
The control subjects will receive physical therapy (exercises and electrotherapy) for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Maryam Hekmatfard
Street address
No. 17, Shahnazari St., Madar Sq., Mirdamad Blvd., School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Morteza Naserbakht
Street address
Hemmat highway, Iran University of Medical Sciences
City
Tehran
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 and Technology
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
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sanjari
Position
Associate professor/ PhD in Biomechanics
Other areas of specialty/work
Street address
No. 17, Shahnazari St., Madar Sq., Mirdamad Blvd., School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sanjarima@alum.sharif.edu
Web page address
http://rehab.iums.ac.ir,sanjari.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sanjari
Position
Associate professor/ PhD in Biomechanics
Other areas of specialty/work
Street address
No. 17, Shahnazari St., Madar Sq., Mirdamad Blvd., School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sanjarima@alum.sharif.edu
Web page address
sanjari.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Maryam Hekmatfard
Position
Msc. in Orthotics and Prosthetics
Other areas of specialty/work
Street address
No. 17, Shahnazari St., Madar Sq., Mirdamad Blvd., School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
ma.hekmat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)