Protocol summary
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Study aim
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Our aim is to determine any differences in the stride-to-stride fluctuations in low back pain patients 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.
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Design
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Twenty four (24) subjects with chronic non specific low back pain will participate in the study.This study is a parallel-group randomized controlled trial in which subjects will be randomly allocated to control and intervention groups.
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Settings and conduct
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The subjects walk on a level motorized treadmill using an eight-camera motion analysis. The data collection will do at first day of treatment and repeat at 3th week and 6th week after treatment. Subjects will be followed one month after the end of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patient with chronic non-specific low back pain and pain intensity from 1 to 6 that their pain lasts at least 6 months.
Non inclusion criteria: Patients with specific low back pain and referral neurological pain to distal of lower limbs and patients who previously used lumbar support.
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Intervention groups
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The control subjects will receive physical therapy (exercises and electrotherapy) and intervention group will receive physical therapy as well as a semirigid LSO, 6-8 hour a day for 6 weeks.
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Main outcome variables
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Pain intensity; disability index; fear avoidance beliefs
General information
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Reason for update
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completion the information at the end of the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016072828310N2
Registration date:
2016-08-25, 1395/06/04
Registration timing:
prospective
Last update:
2020-01-08, 1398/10/18
Update count:
1
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Registration date
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2016-08-25, 1395/06/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research and Technology of Iran University of Medical Sciences
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Expected recruitment start date
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2015-10-22, 1394/07/30
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Expected recruitment end date
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2016-10-21, 1395/07/30
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Actual recruitment start date
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2016-09-01, 1395/06/11
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Actual recruitment end date
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2017-06-30, 1396/04/09
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Trial completion date
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2017-06-30, 1396/04/09
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Scientific title
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Effect of Lumbosacral orthosis on the gait dynamics in chronic non-specific low back pain patients
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Public title
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Effect of Lumbosacral orthosis on low back pain management
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Low back pain intensity from 1 to 6
Low back pain for at least 6 months
3 months from the last treatment session
There should be acute exacerbation periods of low back pain
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
Using drugs that interfere with walking
Any previous use of lumbar supports
gait imbalance and use of assistive devices
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed blindly by a permuted block randomization in which block sizes were randomly varied from two to four and allocation ratio was 1:1. An independent person performed the allocation via sealed, opaque envelopes numbered consequently to ensure the allocation concealment.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessor and participants were blind to group assignment. While the data analysis was blindly conducted, due to the nature of the intervention (PT, LSO) in both groups, the blinding of the participants and outcome assessor during the test procedure was impossible and it didn't take place.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-05-25, 1394/03/04
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Ethics committee reference number
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IR.IUMS.REC.1394.3.41051230
Health conditions studied
1
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Description of health condition studied
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Chronic non-specific low back pain
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ICD-10 code
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M54.9
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ICD-10 code description
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Dorsalgia, unspecified , Backache NOS
Primary outcomes
1
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Description
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pain
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Timepoint
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before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
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Method of measurement
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numerical pain rating scale
2
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Description
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disability
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Timepoint
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before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
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Method of measurement
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Oswestry disability index questionnaire
3
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Description
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fear avoidance
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Timepoint
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before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention
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Method of measurement
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fear avoidance belief questionnaire
Secondary outcomes
1
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Description
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Fractal scaling index
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Timepoint
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before intervention, 3 weeks aftre intervention, 6 weeks after intervention, 1 month after the stop of the intervention
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Method of measurement
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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
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Description
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Intervention group will receive physical therapy (exercises and electrotherapy) as well as a semirigid lumbosacral orthosis for 6 weeks, 8 hour a day.
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Category
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Rehabilitation
2
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Description
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The control subjects will receive physical therapy (exercises and electrotherapy) for 6 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research and Technology
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Individual Participant Data collected for the primary and secondary outcome measures will be shared after de-identification.
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When the data will become available and for how long
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If there is a request from researchers, the data will become available after paper publication.
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To whom data/document is available
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The data will be available for researchers working at the academic institutions.
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Under which criteria data/document could be used
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More analyses on the data should be performed under supervision of the researchers of this study.
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From where data/document is obtainable
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The data would be available through email: ma.hekmat@yahoo.com per requests received from academic researchers.
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What processes are involved for a request to access data/document
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Whenever a request is received, first the researcher should be identified. Second, the aims of the study should be clarified. Further, all ethics related to recruitment of the subjects should be passed. The process will be clarified through email by details.
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Comments
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