Protocol summary
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Study aim
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Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
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Design
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Two arm parallel group clinical trial with single blinded block randomization.
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Settings and conduct
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This study is single blind randomized clinical trial about chronic low back pain that is done in Firuzgar hospital.
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Participants/Inclusion and exclusion criteria
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Patients were included if they:
were more than 18 years old; had axial non radicular refractory low back pain more than 3 Month; had para spinal pain with local tenderness of Facet joint is exacerbated by extension and lateral rotation; had normal MRI.
Patients were excluded if they:
had neurological disorder; had tumor; had general infection or skin infection of injection Site; had coagulopathy; had sensitivity to lidocaine and steroid; had history of back surgery; had Pregnancy;' were non-cooperative patient; had more than tow level or bilateral involvement of Facet joints
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Intervention groups
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First randomized group goes under Medial Branch Block in 2 Levels (same and above level ) under Ultra sound-Guided with 2miligram(mg) Lidocaine and 1mg Triamcinolone and second randomized group goes under Facet joint injection in 2 Levels (same and above level ) under Ultra sound-Guided with 2miligram(mg) Lidocaine and 1mg Triamcinolone.
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Main outcome variables
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The effect of low back pain in ability of daily living, severity of sign
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:
IRCT20180227038889N1
Registration date:
2018-07-31, 1397/05/09
Registration timing:
registered_while_recruiting
Last update:
2019-02-28, 1397/12/09
Update count:
1
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Registration date
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2018-07-31, 1397/05/09
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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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Expected recruitment start date
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2018-05-22, 1397/03/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
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Public title
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Effect of Medial Branch Block and Facet Joint Injection in 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:
Age above the 18 years old.
Axial Non Radicular Low Back Pain that Conservative Treatment more than 3 Month is failed .
Para Spinal Pain with Local Tenderness of Facet Joint that exacerbated with Extension and Lateral Rotation.
MRI is Normal.
Exclusion criteria:
Neurological Disorder
Tumor
General Infection or Skin Infection of Injection Site
Coagulopathy
Sensitivity to Lidocaine and Steroid
Previous Surgery of Back
Pregnancy
Non-Cooperative Patient
More than two level or bilateral involvement of Facet joints
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Age
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From 18 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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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization in which each member of the community has equal and independent chance to be selected. For randomization, the random block method with quad and dual blocks will be used. According to the sample size of 30 peoples, six blocks of quad and four blocks of dual will be generated and numbered using the tracks method. Using blocks of random numbers, the blocks are located at the other end of the screen and will form the sequence of allocation of patients to the treatment groups. Therefore, before choosing participants, the type of treatment that will be received will be unaware and the random sequence produced during the study will be immune from prediction.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patient do not know in witch Randomized Group(Facet Joint Group or Medial Branch Block) are entered.
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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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2018-02-03, 1396/11/14
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Ethics committee reference number
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IR.IUMS.FMD.REC
Health conditions studied
1
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Description of health condition studied
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Lumbar facetogenic pain syndrome
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ICD-10 code
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M54.8
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ICD-10 code description
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Other dorsalgia
Primary outcomes
1
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Description
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The effect of low back pain on Ability of Daily Living
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Timepoint
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Zero, Four weeks
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Method of measurement
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Oswestry Disability Index questioner
2
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Description
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Severity of sign
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Timepoint
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Zero, One week , Four weeks ,Twelve weeks
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Method of measurement
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Visual analog scale
Intervention groups
1
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Description
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Intervention group 1: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
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Category
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Treatment - Other
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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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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Yes - There is a plan to make this available
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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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All of patients data after non-identification have possibility of sharing
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When the data will become available and for how long
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After six months of results print
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To whom data/document is available
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For researchers work in University and Academic institutes are available
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Under which criteria data/document could be used
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with mention of source can be printed by other researchers
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From where data/document is obtainable
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Dr Amirhossein Sadeghian-sa.amirhossein@yahoo.com
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What processes are involved for a request to access data/document
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After authentication,data will be available
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Comments
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