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Protocol summary
Entrance 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.
Exit criteria:
Obese Patient; Neurological Disorder; Tumor, General Infection or Skin Infection of Injection Site; Coagulopathy; Sensitivity to Lidocaine and Steroid; Previous Surgery of Back; Pregnancy;'v Non-Cooperative Patient
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
Entrance criteriaPatients were included if they: Age above thewere more than 18 years old; Axial Non Radicular Low Back Pain that conservative treatmenthad axial non radicular refractory low back pain more than 3 Month is failed; Para Spinal Painhad para spinal pain with Local Tendernesslocal tenderness of Facet Joint thatjoint is exacerbated with Extensionby extension and Lateral Rotationlateral rotation; had normal MRI is Normal. Exit criteriaPatients were excluded if they: Obese Patienthad neurological disorder; Neurological Disorderhad tumor; Tumor, General Infectionhad general infection or Skin Infectionskin infection of Injectioninjection Site; Coagulopathyhad coagulopathy; Sensitivityhad sensitivity to Lidocainelidocaine and Steroidsteroid; Previous Surgeryhad history of Backback surgery; had Pregnancy;'v Non were non-Cooperative Patientcooperative patient; had more than tow level or bilateral involvement of Facet joints
شرایط ورود:
سن بیش از 18 سال، کمردرد غیر رادیکولار اگزیال که به درمان کانسرواتیو بیش از 3 ماه پاسخ نداده است، درد پارااسپاینال به همراه تندرنس لوکال منطبق بر مفصل فاست که در اکستنشن و لترال فلکشن تشدید می شود، MRI نرمال
شرایط خروج:
بیمارچاق ،نقص نورولوژیک، تومور،عفونت جنرال و عفونت پوستی محل تزریق،کوآگولوپاتی،حساسیت به لیدوکایین و استروئید،جراحی قبلی، حاملگی و عدم همکاری بیمار
شرایط ورود:
سن بیش از 18 سال، کمردرد اگزیال غیر رادیکولار مقاوم به درمان بیش از 3 ماه، درد پارااسپاینال به همراه تندرنس لوکال منطبق بر مفصل فاست که در اکستنشن و لترال فلکشن تشدید می شود، MRI نرمال
شرایط خروج:
نقص نورولوژیک، تومور،عفونت جنرال و عفونت پوستی محل تزریق،کوآگولوپاتی،حساسیت به لیدوکایین و استروئید،جراحی قبلی، حاملگی , عدم همکاری بیمار و درگیری بیش از دوسطح یا درگیری دو طرفه مفاصل فاست
شرایط ورود: سن بیش از 18 سال، کمردرد اگزیال غیر رادیکولار اگزیال کهمقاوم به درمان کانسرواتیو بیش از 3 ماه پاسخ نداده است، درد پارااسپاینال به همراه تندرنس لوکال منطبق بر مفصل فاست که در اکستنشن و لترال فلکشن تشدید می شود، MRI نرمال شرایط خروج: بیمارچاق ،نقص نورولوژیک، تومور،عفونت جنرال و عفونت پوستی محل تزریق،کوآگولوپاتی،حساسیت به لیدوکایین و استروئید،جراحی قبلی، حاملگی و, عدم همکاری بیمار و درگیری بیش از دوسطح یا درگیری دو طرفه مفاصل فاست
General information
Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Effect of Medial Branch Block and Facet Joint Injection in treatment of chronic low back pain
Comparison of the EffectivenessEffect of Medial Branch Block withand Facet Joint Injection under Ultrasonography-Guide in patient withtreatment of chronic low back pain
مقایسه اثر درمانی بلاک عصب شاخه مدیال با تزریق مفصل فاست تحت گاید سونوگرافی در بیماران دارای کمردرد مزمن
بررسی اثر بلاک عصب شاخه مدیال و تزریق مفصل فاست در درمان کمردرد مزمن
مقایسهبررسی اثر درمانی بلاک عصب شاخه مدیال باو تزریق مفصل فاست تحت گاید سونوگرافی در بیماران دارایدرمان کمردرد مزمن
Obese Patient
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
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
Obese Patient 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
بیمارچاق
نقص نورولوژیک،
تومور
عفونت جنرال یا عفونت پوستی محل تزریق
کوآگولوپاتی
حساسیت به لیدوکایین و استروئید
جراحی قبلی کمر
حاملگی
عدم همکاری بیمار
نقص نورولوژیک،
تومور
عفونت جنرال یا عفونت پوستی محل تزریق
کوآگولوپاتی
حساسیت به لیدوکایین و استروئید
جراحی قبلی کمر
حاملگی
عدم همکاری بیمار
درگیری بیش از دوسطح یا درگیری دو طرفه مفصل فاست
بیمارچاق نقص نورولوژیک، تومور عفونت جنرال یا عفونت پوستی محل تزریق کوآگولوپاتی حساسیت به لیدوکایین و استروئید جراحی قبلی کمر حاملگی عدم همکاری بیمار درگیری بیش از دوسطح یا درگیری دو طرفه مفصل فاست
Patients are allocated in Tow Groups with Block Randomization. If first Patient have more than One Year Pain, he or she will enter in Medial Branch Block and if have less than One Year Pain, he or she will enter in Facet Joint Block. Second Patient if have more than One Year Pain, he or she will now enter in Facet Joint Group and if have less than One Year Pain, he or she will enter in Medial Branch Block. The others are allocated as the same way.
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.
PatientsSimple 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 allocated in Tow Groups with Block Randomization. If first Patient have more than One Year Pain, he or shelocated at the other end of the screen and will enter in Medial Branch Blockform 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 if have less than One Year Pain, he or shethe random sequence produced during the study will enter in Facet Joint Blockbe immune from prediction. Second Patient if have more than One Year Pain, he or she will now enter in Facet Joint Group and if have less than One Year Pain, he or she will enter in Medial Branch Block. The others are allocated as the same way.
بیماران توسط روش تصادف سازی بلوک به دو گروه تقسیم می شوند. اولین بیمار اگر بیش از یکسال درد دارد وارد گروه گروه بلاک عصب شاخه مدیال و اگر کمتر از یکسال درد دارد وارد گروه تزریق مفصل فاست می شود.دومین بیمار اگر بیشتر از یکسال درد داشته باشد اکنون وارد گروه تزریق مفصل فاست و اگر کمتر از یکسال درد داشته باشد وارد گروه بلاک عصب شاخه مدیال می شود .بقیه بیماران به همین صورت تقسیم می شوند.
تصادفی سازی ساده كه در اين روش هريك از اعضاي جامعه داراي شانس مساوي و مستقل براي انتخاب شدن، هستند. برای اعمال تصادفی سازی از روش بلوکهای تصادفی با بلوکهای چهارتایی و دوتايي استفاده خواهد شد. با توجه به حجم نمونه 30 نفره، 6 بلوک چهارتایی و 4 بلوك دوتايي با استفاده از روش جايگشتها توليد و شماره گذاري خواهند شد. با استفاده از جدول اعداد تصادفي بلوكها در كناريكديگر قرار گرفته و توالي تخصيص بيماران به گروه هاي درماني را تشكيل خواهند داد. لذا قبل از انتخاب شرکت کنندگان، از نوع درمانی که دریافت خواهد شد، بی اطلاع خواهد بود و همچنین توالی تصادفی تولید شده در طول مطالعه از پیش بینی مصون خواهد بود.
بیماران توسطتصادفی سازی ساده كه در اين روش تصادفهريك از اعضاي جامعه داراي شانس مساوي و مستقل براي انتخاب شدن، هستند. برای اعمال تصادفی سازی بلوکاز روش بلوکهای تصادفی با بلوکهای چهارتایی و دوتايي استفاده خواهد شد. با توجه به دوحجم نمونه 30 نفره، 6 بلوک چهارتایی و 4 بلوك دوتايي با استفاده از روش جايگشتها توليد و شماره گذاري خواهند شد. با استفاده از جدول اعداد تصادفي بلوكها در كناريكديگر قرار گرفته و توالي تخصيص بيماران به گروه تقسیم می شوندهاي درماني را تشكيل خواهند داد. اولین بیمار اگر بیشلذا قبل از یکسال درد دارد وارد گروه گروه بلاک عصب شاخه مدیالانتخاب شرکت کنندگان، از نوع درمانی که دریافت خواهد شد، بی اطلاع خواهد بود و اگر کمترهمچنین توالی تصادفی تولید شده در طول مطالعه از یکسال درد دارد وارد گروه تزریق مفصل فاست می شود.دومین بیمار اگر بیشتر از یکسال درد داشته باشد اکنون وارد گروه تزریق مفصل فاست و اگر کمتر از یکسال درد داشته باشد وارد گروه بلاک عصب شاخه مدیال می شود پیش بینی مصون خواهد بود.بقیه بیماران به همین صورت تقسیم می شوند.
Health conditions studied
#1
empty
M54.8
M54.8
Other dorsalgia
Other dorsalgia
Primary outcomes
#1
Zero, One week , Four weeks
Zero, One week , Four weeks ,Twelve weeks
Zero, One week , Four weeks ,Twelve weeks
صفر , یک هفته , چهار هفته
صفر , یک هفته , چهار هفته , دوازده هفته
صفر , یک هفته , چهار هفته , دوازده هفته
Intervention groups
#1
Intervention group: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Intervention group 1: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Intervention group 1: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
گروه مداخله: تزریق مفصل فاست کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
"گروه مداخله 1:" تزریق مفصل فاست کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
"گروه مداخله 1:" تزریق مفصل فاست کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
#2
Intervention group: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Intervention group 2: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Intervention group 2: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
گروه مداخله: بلاک عصب شاخه مدیال کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
"گروه مداخله 2:" بلاک عصب شاخه مدیال کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
"گروه مداخله 2:" بلاک عصب شاخه مدیال کمری با مخلوط لیدوکایین و کورتیکواسترویید تحت گاید سونوگرافی توسط متخصص طب فیزیکی و توانبخشی
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
Acronym
IRCT registration information
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
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
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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