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General information
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30
30
2018-09-23, 1397/07/01
2023-08-22, 1402/05/31
20182023-0908-2322 00:00:00
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2018-08-01, 1397/05/10
2018-08-01 00:00:00
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2023-08-01, 1402/05/10
2023-08-01 00:00:00
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2023-08-22, 1402/05/31
2023-08-22 00:00:00
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Actual recruitment dates were added to complete the trial record. Recruitment began later than originally anticipated due to delays in study initiation, interruptions during the COVID-19 pandemic, and institutional circumstances. No participant was enrolled before the actual recruitment start date reported here.
Actual recruitment dates were added to complete the trial record. Recruitment began later than originally anticipated due to delays in study initiation, interruptions during the COVID-19 pandemic, and institutional circumstances. No participant was enrolled before the actual recruitment start date reported here.
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تاریخهای واقعی جذب شرکتکنندگان برای تکمیل سوابق کارآزمایی اضافه شدند. فرآیند جذب به دلیل تأخیر در آغاز مطالعه، وقفههای ناشی از همهگیری کووید-۱۹ و شرایط سازمانی، دیرتر از زمان پیشبینیشدهی اولیه آغاز شد. هیچ شرکتکنندهای پیش از تاریخ واقعی شروع جذب که در اینجا گزارش شده است، ثبتنام نشدند.
تاریخهای واقعی جذب شرکتکنندگان برای تکمیل سوابق کارآزمایی اضافه شدند. فرآیند جذب به دلیل تأخیر در آغاز مطالعه، وقفههای ناشی از همهگیری کووید-۱۹ و شرایط سازمانی، دیرتر از زمان پیشبینیشدهی اولیه آغاز شد. هیچ شرکتکنندهای پیش از تاریخ واقعی شروع جذب که در اینجا گزارش شده است، ثبتنام نشدند.
Protocol summary
Study aim
Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Design
Two arm parallel group clinical trial with single blinded block randomization.
Settings and conduct
This study is single blind randomized clinical trial about chronic low back pain that is done in Firuzgar hospital.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
The effect of low back pain in ability of daily living, severity of sign
General information
Reason for update
Actual recruitment dates were added to complete the trial record. Recruitment began later than originally anticipated due to delays in study initiation, interruptions during the COVID-19 pandemic, and institutional circumstances. No participant was enrolled before the actual recruitment start date reported here.
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038889N1
Registration date:2018-07-31, 1397/05/09
Registration timing:prospective
Last update:2026-09-12, 1405/06/21
Update count:2
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Amirhossein Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8846 8248
Email address
sa.amirhossein@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
2018-08-01, 1397/05/10
Actual recruitment end date
2023-08-01, 1402/05/10
Trial completion date
2023-08-22, 1402/05/31
Scientific title
Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Public title
Effect of Medial Branch Block and Facet Joint Injection in treatment of chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient do not know in witch Randomized Group(Facet Joint Group or Medial Branch Block) are entered.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Shahid Hemat Highway,Ethics committee of Iran University of Medical Science,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.IUMS.FMD.REC
Health conditions studied
1
Description of health condition studied
Lumbar facetogenic pain syndrome
ICD-10 code
M54.8
ICD-10 code description
Other dorsalgia
Primary outcomes
1
Description
The effect of low back pain on Ability of Daily Living
Timepoint
Zero, Four weeks
Method of measurement
Oswestry Disability Index questioner
2
Description
Severity of sign
Timepoint
Zero, One week , Four weeks ,Twelve weeks
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Category
Treatment - Other
2
Description
Intervention group 2: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert