Protocol summary
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Study aim
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The aim of this study is to evaluate the effect of spinal stabilization exercises on the spine kinematics during walking.
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Design
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A concealed, controlled clinical trial with a parallel group design of 30 patients healthy
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Settings and conduct
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Patients with a history of at least 3 months Non-specific chronic Low Back Pain (NCLBP) in the range of 18-45 years will enrolled after filling out a consent form. Each patient will complete the perceived pain questionnaire and the Oswestry Disability Questionnaire. Then in the first session, the spine kinematics will be evaluated in the motion analysis laboratory. Markers are placed on the trunk (acromion process and T12 ), lumbar (T12, L3 and S2), pelvis (bilateral ASIS and PSIS) and foot (bilateral posterior heel center and fifth MTP) and the patient is asked to walk with self-selected daily speed in a direction of 10 meters at a rate of 3 times without load and 3 times with a load approximately 10% of their body weight. Then, each patient participate in the 16 sessions of patient-specific spinal stabilization exercise training that will be given three times a week for 6 weeks. In the final session, pain, disability and spinal column kinematic will be assessed.
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Participants/Inclusion and exclusion criteria
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Inclusion:
Low back pain from lower thorasic rib to the upper gluteal fold lasted more than 12 weeks.
The range of pain would between 3-6 according to the VAS
Exclusion: acute low back pain, any illness and disorders in other limbs, gait disturbance, Any medical condition who have contraindications to exercise therapy.
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Intervention groups
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16 sessions of patient-specific spinal stabilization exercise training in patients group, no intervention will be made in the control group.
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Main outcome variables
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pain, disability and kinematic parameters of the spine
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016080829264N1
Registration date:
2016-08-28, 1395/06/07
Registration timing:
prospective
Last update:
2019-05-12, 1398/02/22
Update count:
1
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Registration date
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2016-08-28, 1395/06/07
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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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IRAN University of Medical Sciences
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2017-04-19, 1396/01/30
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Actual recruitment start date
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2016-10-18, 1395/07/27
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Actual recruitment end date
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2017-04-08, 1396/01/19
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Trial completion date
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2017-06-10, 1396/03/20
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Scientific title
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The effect of 16 sessions core stabilization exercises on spine kinematics during walking both with and without load in patients with non-specific chronic low back pain and comparison with healthy control group
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Public title
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The effects of spinal specific exercise therapy for treatment of chronic low back pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Low back pain from lower thorasic rib to the upper gluteal fold
low back pain which lasted more than 12 weeks
The range of pain would between 3-6 according to the VAS
Exclusion criteria:
Any medical condition who have contraindications to exercise therapy.
Acute low back pain or back pain that occurred in less than 12 weeks.
BMI above 25 kg/m2.
Sciatic nerve root involvement. Pain radiating to the leg below the knee. Feeling paresthesia in the legs. Motor deficits in the lower limb muscles (MMT, grade 3.5 and less on the basis of Kendall approach).
Acute spinal disc herniation (MRI reports or medical reports). History of surgery and lumbar spine fractures or other spinal structures (self-reported). Malignancy(self-reported). Pregnancy(self-reported). Radicular symptoms during daily activities, especially walking (self-reported).
During the intervention, the patient will be banned from any sports activities.
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2016-07-31, 1395/05/10
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Ethics committee reference number
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IR.IUMS.REC 1395.9211342205
Health conditions studied
1
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Description of health condition studied
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chrionic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Loin pain, Low back strain
Primary outcomes
1
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Description
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spinal kinematic
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Timepoint
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before and after treatment
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Method of measurement
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motion analysis system of qualysis
2
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Description
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disability
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Timepoint
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before and after treatment
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Method of measurement
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ODI disability quasionnare
3
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Description
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pain
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Timepoint
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before and after treatment
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Method of measurement
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100 mm VAS scale
Secondary outcomes
1
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Description
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pain due to the core stabilization exercise
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Timepoint
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during assessment and treatment
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Method of measurement
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self reported
Intervention groups
1
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Description
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specific spinal stabilization exercise that lasted in 16 sessions and 6 weeks and 3 times in each week. each session lasted for 45 minutes.
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Category
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Rehabilitation
2
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Description
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In control healthy subjects, There will be no intervention.
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Category
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N/A
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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Iran University of Medical Sciences
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available