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Protocol summary
Patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the median nerve area) referred to the clinic and according to electrodiagnostic criteria with mild to moderate carpal tunnel syndrome were included in the study and patients with severe carpal tunnel syndrome (based on Electrodiagnosis data) and symptoms of atrophy of the pelvic region were excluded from the study.
Patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the median nerve area) referred to the clinic and according to electrodiagnostic criteria with mild to moderate carpal tunnel syndrome were included in the study and patients with severe carpal tunnel syndrome (based on Electrodiagnosis data) and signs of atrophy of the thenar muscles were excluded from the study.
Patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the median nerve area) referred to the clinic and according to electrodiagnostic criteria with mild to moderate carpal tunnel syndrome were included in the study and patients with severe carpal tunnel syndrome (based on Electrodiagnosis data) and symptomssigns of atrophy of the pelvic regionthenar muscles were excluded from the study.
بیمارانی که با علائم و نشانه های سندرم تونل کارپ( شامل درد و اختلالات حسی در محدوده عصب مدیان) به درمانگاه تمراجعه کرده و براساس معیارهای الکترودیاگنوستیک دارای سندرم تونل کارپال خفیف تا متوسط باشند وارد مطالعه شده و بیمارانی که سندرم تونل کارپ شدید (بر مبنای داده های الکترودیاگنوزیس) و علائم آتروفی ناحیه تنار داشتند از ورود به مطالعه منع شدند.
بیمارانی که با علائم و نشانه های سندرم تونل کارپ( شامل درد و اختلالات حسی در محدوده عصب مدیان) به درمانگاه تمراجعه کرده و براساس معیارهای الکترودیاگنوستیک دارای سندرم تونل کارپال خفیف تا متوسط باشند وارد مطالعه شده و بیمارانی که سندرم تونل کارپ شدید (بر مبنای داده های الکترودیاگنوزیس) و علائم آتروفی عضلات تنار داشتند از ورود به مطالعه منع شدند.
بیمارانی که با علائم و نشانه های سندرم تونل کارپ( شامل درد و اختلالات حسی در محدوده عصب مدیان) به درمانگاه تمراجعه کرده و براساس معیارهای الکترودیاگنوستیک دارای سندرم تونل کارپال خفیف تا متوسط باشند وارد مطالعه شده و بیمارانی که سندرم تونل کارپ شدید (بر مبنای داده های الکترودیاگنوزیس) و علائم آتروفی ناحیهعضلات تنار داشتند از ورود به مطالعه منع شدند.
Group A Patients: In group A, corticosteroid injections will be performed under ultrasound guidance, under sterile conditions and using the free hand technique.
Group B Patients: Each patient in the radial shock wave treatment group receives two rounds of treatment one week apart with the characteristics of severity, frequency, number of shocks, and the type of device:
2 Bar, 6 Hz frequency, 2000 shocks
Group A Patients: In group A, corticosteroid injections will be performed under ultrasound guidance, under sterile conditions and using the free hand technique.
Group B Patients: Each patient in the radial shock wave treatment group receives two rounds of treatment one week apart with the characteristics of severity, frequency, number of shocks, and the type of device:
1.5 Bar, 6 Hz frequency, 2000 shocks
For both groups, the standard treatment will be 6 weeks using a wrist splint.
Group A Patients: In group A, corticosteroid injections will be performed under ultrasound guidance, under sterile conditions and using the free hand technique. Group B Patients: Each patient in the radial shock wave treatment group receives two rounds of treatment one week apart with the characteristics of severity, frequency, number of shocks, and the type of device: 21.5 Bar, 6 Hz frequency, 2000 shocks For both groups, the standard treatment will be 6 weeks using a wrist splint.
گروه A بیماران: در گروه A تزریق کورتیکواستروئید تحت هدایت سونوگرافی، در شرایط استریل و با استفاده از تکنیک Free hand انجام خواهد شد.
گروه B بیماران: هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند:
2 Bar, 6 Hz frequency, 2000 shocks
گروه A بیماران: در گروه A تزریق کورتیکواستروئید تحت هدایت سونوگرافی، در شرایط استریل و با استفاده از تکنیک Free hand انجام خواهد شد.
گروه B بیماران: هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند:
1.5Bar, 6 Hz frequency, 2000 shocks
برای هر دو گروه درمان استاندارد استفاده 6 هفته از اسپلینت مچ دست انجام خواهد شد .
گروه A بیماران: در گروه A تزریق کورتیکواستروئید تحت هدایت سونوگرافی، در شرایط استریل و با استفاده از تکنیک Free hand انجام خواهد شد. گروه B بیماران: هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند: 2 Bar1.5Bar, 6 Hz frequency, 2000 shocks برای هر دو گروه درمان استاندارد استفاده 6 هفته از اسپلینت مچ دست انجام خواهد شد .
Boston Questionnaire Score, EDX Criteria, Ultrasound Criteria, Injection Complications
Boston Questionnaire Score, visual analogue score for pain (VAS ), EDX Criteria, Ultrasound Criteria, Injection Complications
Boston Questionnaire Score, visual analogue score for pain (VAS ), EDX Criteria, Ultrasound Criteria, Injection Complications
Due to the covid-19 pandemic and also the start of sampling after the finalization of the trial registration in the Iranian Clinical Trial Registration Center, the start and end dates of sampling and also the number of samples per person were updated.
In both intervention groups, standard wrist splint treatment will be performed for six weeks.
In the shockwave therapy intervention group, the device intensity profile was performed from 2 to 1.5 due to better patient tolerance as well as similar proven effects in studies with this intensity.
The sampling site of Hazrat Rasool Akram Hospital was updated.
Due to the covid-19 pandemic and also the start of sampling after the finalization of the trial registration in the Iranian Clinical Trial Registration Center, the start and end dates of sampling and also the number of samples per person were updated. In both intervention groups, standard wrist splint treatment will be performed for six weeks. In the shockwave therapy intervention group, the device intensity profile was performed from 2 to 1.5 due to better patient tolerance as well as similar proven effects in studies with this intensity. The sampling site of Hazrat Rasool Akram Hospital was updated.
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با توجه به پاندمی covid-19 و همچنین شروع نمونه گیری بعد از نهایی شدن ثبت کارآزمایی در مرکز ثبت کار آزمایی بالینی ایران تاریخ شروع و پایان نمونه گیری و همچنین امکان تعداد نمونه در هر نفر بروز رسانی شد.
در هر دو گروه مداخله درمان استاندارد استفاده از 6 هفته اسپلینت مچ دست انجام خواهد گرفت.
در گروه مداخله استفاده از شاک ویو تراپی مشخصات شدت دستگاه از 2 به 1.5 به علت تحمل بهتر بیمار و همچنین تاثیرات ثابت شده مشابه در مطالعات با این شدت انجام شد .
محل نمونه گیری بیمارستان حضرت رسول اکرم (ص ) به روز رسانی شد.
با توجه به پاندمی covid-19 و همچنین شروع نمونه گیری بعد از نهایی شدن ثبت کارآزمایی در مرکز ثبت کار آزمایی بالینی ایران تاریخ شروع و پایان نمونه گیری و همچنین امکان تعداد نمونه در هر نفر بروز رسانی شد. در هر دو گروه مداخله درمان استاندارد استفاده از 6 هفته اسپلینت مچ دست انجام خواهد گرفت. در گروه مداخله استفاده از شاک ویو تراپی مشخصات شدت دستگاه از 2 به 1.5 به علت تحمل بهتر بیمار و همچنین تاثیرات ثابت شده مشابه در مطالعات با این شدت انجام شد . محل نمونه گیری بیمارستان حضرت رسول اکرم (ص ) به روز رسانی شد.
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Depending on whether one or both wrists are involved, each participant may provide one or two samples.
Depending on whether one or both wrists are involved, each participant may provide one or two samples.
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بر اساس اینکه یک مچ یا هر دو مچ هر نفر درگیر باشد امکان دارد هر فرد شرکت کنننده یک یا دو نمونه فراهم کند.
بر اساس اینکه یک مچ یا هر دو مچ هر نفر درگیر باشد امکان دارد هر فرد شرکت کنننده یک یا دو نمونه فراهم کند.
Intervention groups
#1
Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection
Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection Also use a wrist splint for 6 weeks
Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection Also use a wrist splint for 6 weeks
گروه مداخله: گروه تزریق موضعی چهل میلی گرم تریامسینولون تحت هدایت سونوگرافی با یک نوبت تزریق
گروه مداخله: گروه تزریق موضعی چهل میلی گرم تریامسینولون تحت هدایت سونوگرافی با یک نوبت تزریق و همچنین استفاده از اسپلینت مچ دست برای 6 هفته
گروه مداخله: گروه تزریق موضعی چهل میلی گرم تریامسینولون تحت هدایت سونوگرافی با یک نوبت تزریق و همچنین استفاده از اسپلینت مچ دست برای 6 هفته
#2
Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent.
Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent. Also use a wrist splint for 6 weeks
Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent. Also use a wrist splint for 6 weeks
گروه مداخله: گروه درمان شوک ویو رادیال، هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE : (BTL-6000 SWT, RADIAL shockwave mode )پروب در موقعیت عمود بر ناحیه پالم بیمار بین crease دیستال مچ و Kaplan's cardinal line قرار می گیرد. ژل اولتراسوند به عنوان عامل اتصال دهنده مورد استفاده قرار می گیرد.
گروه مداخله: گروه درمان شوک ویو رادیال، هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE : (BTL-6000 SWT, RADIAL shockwave mode )پروب در موقعیت عمود بر ناحیه پالم بیمار بین crease دیستال مچ و Kaplan's cardinal line قرار می گیرد. ژل اولتراسوند به عنوان عامل اتصال دهنده مورد استفاده قرار می گیرد.و همچنین استفاده از اسپلینت مچ دست برای 6 هفته
گروه مداخله: گروه درمان شوک ویو رادیال، هر بیمار در گروه درمان شوک ویو رادیال دو نوبت درمان به فاصله یک هفته با مشخصات شدت، فرکانس، تعداد شوک و نوع دستگاه زیر دریافت می کند: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE : (BTL-6000 SWT, RADIAL shockwave mode )پروب در موقعیت عمود بر ناحیه پالم بیمار بین crease دیستال مچ و Kaplan's cardinal line قرار می گیرد. ژل اولتراسوند به عنوان عامل اتصال دهنده مورد استفاده قرار می گیرد.گیرد.و همچنین استفاده از اسپلینت مچ دست برای 6 هفته
Recruitment centers
#1
Name of recruitment center - English: Firoozgar and Hazrat Fatemeh Hospital and Hazrat Rasoul Hospital
Name of recruitment center - Persian: بيمارستان آموزشي درماني فیروزگر و حضرت فاطمه (س) و بیمارستان حضرت رسول (ص
Full name of responsible person - English: Labaneh Janbazi
Full name of responsible person - Persian: لبانه جانبازی
Street address - English: Tehran-Firoozgar and Hazrat Fatemeh Hospital and Hazrat Rasoul Hospital
Street address - Persian: تهران-بيمارستان آموزشي درماني فیروزگر و حضرت فاطمه (س) و بیمارستان حضرت رسول (ص
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 8711111111
Phone: +98 31 5550 0111
Fax:
Email: morovati.hawre@gmail.com
Web page address:
Name of recruitment center - English: Hazrate Fatemeh(S) Hospital
Name of recruitment center - Persian: بیمارستان حضرت فاطمه (س)
Full name of responsible person - English: Lobaneh Janbazi
Full name of responsible person - Persian: لبانه جانبازی
Street address - English: 21th Alley, Seyed Jamaloddin Asad Abadi St
Street address - Persian: خیابان سید جمال الدین اسد آبادی ، خیابان بیست و یکم ، جنب پارک شفق ،بیمارستان حضرت فاطمه (س)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1433933111
Phone: +98 21 8871 7272
Fax: +98 21 8810 7658
Email: lobaneh.janbazi@gmail.com
Web page address: http://crtfatima.iums.ac.ir/
Name of recruitment center - English: Firoozgar and Hazrat Fatemeh Hospital and Hazrat RasoulHazrate Fatemeh(S) Hospital Name of recruitment center - Persian: بيمارستان آموزشي درماني فیروزگر وبیمارستان حضرت فاطمه (س) و بیمارستان حضرت رسول (ص Full name of responsible person - English: LabanehLobaneh Janbazi Full name of responsible person - Persian: لبانه جانبازی Street address - English: Tehran-Firoozgar and Hazrat Fatemeh Hospital and Hazrat Rasoul Hospital21th Alley, Seyed Jamaloddin Asad Abadi St Street address - Persian: تهران-بيمارستان آموزشي درماني فیروزگرخیابان سید جمال الدین اسد آبادی ، خیابان بیست و یکم ، جنب پارک شفق ،بیمارستان حضرت فاطمه (س) و بیمارستان حضرت رسول (ص City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 87111111111433933111 Phone: +98 31 5550 011121 8871 7272 Fax: +98 21 8810 7658 Email: morovati.hawrelobaneh.janbazi@gmail.com Web page address: http://crtfatima.iums.ac.ir/
#2
Name of recruitment center - English: Hazrat Rasul Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرک (ص)
Full name of responsible person - English: Naseh Yousefi
Full name of responsible person - Persian: ناصح یوصفی
Street address - English: Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Ave,
Street address - Persian: ستارخان - خ. نیایش - نبش خیابان منصوری - بیمارستان حضرت رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6435 1000
Fax: +98 21 6650 2248
Email: nasehusefi@gmail.com
Web page address: https://hrmc.iums.ac.ir/
Name of recruitment center - English: Hazrat Rasul Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم (ص)
Full name of responsible person - English: Naseh Yousefi
Full name of responsible person - Persian: ناصح یوصفی
Street address - English: Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Ave,
Street address - Persian: ستارخان - خ. نیایش - نبش خیابان منصوری - بیمارستان حضرت رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6435 1000
Fax: +98 21 6650 2248
Email: nasehusefi@gmail.com
Web page address: https://hrmc.iums.ac.ir/
Name of recruitment center - English: Hazrat Rasul Akram Hospital Name of recruitment center - Persian: بیمارستان حضرت رسول اکرکاکرم (ص) Full name of responsible person - English: Naseh Yousefi Full name of responsible person - Persian: ناصح یوصفی Street address - English: Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Ave, Street address - Persian: ستارخان - خ. نیایش - نبش خیابان منصوری - بیمارستان حضرت رسول اکرم (ص) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۵۶۱۳۱۳۱ Phone: +98 21 6435 1000 Fax: +98 21 6650 2248 Email: nasehusefi@gmail.com Web page address: https://hrmc.iums.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Labaneh Janbazi
Full name of responsible person - Persian: لبانه جانبازی
Street address - English: Tehran-Iran University of Medical Sciences
Street address - Persian: تهران-دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 8711111111
Phone: +98 31 5550 0111
Fax:
Email: morovati.hawre@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Abbas Motevalian
Full name of responsible person - Persian: سید عباس متولیان
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax: +98 21 8670 2503
Email: motevalian.a@iums.ac.ir
Web page address: https://vcr.iums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Labaneh JanbaziSeyed Abbas Motevalian Full name of responsible person - Persian: لبانه جانبازیسید عباس متولیان Street address - English: Tehran-Iran University of Medical Sciences, Shahid Hemmat Highway Street address - Persian: تهران-بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 87111111111449614535 Phone: +98 31 5550 011121 8670 2504 Fax: +98 21 8670 2503 Email: morovati.hawremotevalian.a@gmail.comiums.ac.ir Web page address: https://vcr.iums.ac.ir/
Protocol summary
Study aim
Comparison of the effect of shockwave therapy and steroid injection on sonographic and electrodiagnostic findings in carpal tunnel syndrome...
Design
Two-group clinical trial, with parallel, randomized groups, on 60 patients. Random blocking method was used for randomization.
Settings and conduct
In this prospective and randomized clinical trial study, patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the median nerve area) went to the specialized clinic of physical medicine and rehabilitation of Firoozgar and Hazrat Fatemeh Hospital. (PBUH) and Hazrat Rasool (PBUH) Hospital are referred and their disease is confirmed by EMG-NCS and according to electrodiagnostic criteria, they have mild to moderate carpal tunnel syndrome.
Participants/Inclusion and exclusion criteria
Patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the median nerve area) referred to the clinic and according to electrodiagnostic criteria with mild to moderate carpal tunnel syndrome were included in the study and patients with severe carpal tunnel syndrome (based on Electrodiagnosis data) and signs of atrophy of the thenar muscles were excluded from the study.
Intervention groups
Group A Patients: In group A, corticosteroid injections will be performed under ultrasound guidance, under sterile conditions and using the free hand technique.
Group B Patients: Each patient in the radial shock wave treatment group receives two rounds of treatment one week apart with the characteristics of severity, frequency, number of shocks, and the type of device:
1.5 Bar, 6 Hz frequency, 2000 shocks
For both groups, the standard treatment will be 6 weeks using a wrist splint.
Main outcome variables
Boston Questionnaire Score, visual analogue score for pain (VAS ), EDX Criteria, Ultrasound Criteria, Injection Complications
General information
Reason for update
Due to the covid-19 pandemic and also the start of sampling after the finalization of the trial registration in the Iranian Clinical Trial Registration Center, the start and end dates of sampling and also the number of samples per person were updated.
In both intervention groups, standard wrist splint treatment will be performed for six weeks.
In the shockwave therapy intervention group, the device intensity profile was performed from 2 to 1.5 due to better patient tolerance as well as similar proven effects in studies with this intensity.
The sampling site of Hazrat Rasool Akram Hospital was updated.
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048503N1
Registration date:2020-09-25, 1399/07/04
Registration timing:prospective
Last update:2020-12-03, 1399/09/13
Update count:1
Registration date
2020-09-25, 1399/07/04
Registrant information
Name
Hawre Morovati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
morovati.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-03, 1399/09/13
Expected recruitment end date
2021-02-01, 1399/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of shockwave therapy and steroid injection on sonographic and electrodiagnostic findings in carpal tunnel syndrome
Public title
Comparison of the effect of shock wave therapy and steroid injection in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Referrals of patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the area of the median nerve)
Patients with mild to moderate carpal tunnel syndrome according to electrodiagnostic criteria
Exclusion criteria:
Severe carpal tunnel syndrome (based on electrodiagnosis data).
Symptoms of atrophy of Tanar area
Contraindications to corticosteroid injections (including allergy to corticosteroids and symptoms of skin infection at the injection site, local abscess at the injection site, patients with immunodeficiency, phobia to needles)
Diseases that mimic the symptoms of CTS, such as polyneuropathy, cervical radiculopathy, thoracic outlet syndrome,
Surgical treatment or topical injection in the last six months
Neoplastic or traumatic origin of pain and fracture of wrist bones
Age under 18 years
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Depending on whether one or both wrists are involved, each participant may provide one or two samples.
Randomization (investigator's opinion)
Randomized
Randomization description
After sampling, which will be easy as sampling, patients will be randomly (using random blocking method) in one of the two groups of 40 mg triamcinolone topical injection under the guidance of sonography and shock wave treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Sciences
Street address
Iran University of Medical sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
8739118631
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.IUMS.FMD.REC.1399.272
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Electrodiagnostic criteria in the study
Timepoint
For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months.
Method of measurement
Electro-diagnostic assessment will conduct with Natus (Synergy ultrapro S100) device by a physical medicine specialist for all patients. The diagnostic criteria of Carpal Tunnel Syndrome based on electrodiagnostic findings included: Distal latency of median sensory nerve action potential (SNAP) of third finger <3.6 and distal latency of median compound muscle action potential(CMAP) of abductor pollicis brevis (APB) muscle <4.2. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of abductor pollicis brevis, it was moderate Carpal Tunnel Syndrome. The needle electromyography will be performed for other muscles of upper limbs to roll out other diagnosis for example : cervical radiculopathies , plexopathies and other median nerve entrapments.
2
Description
Sonographic Evaluation
Timepoint
For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months.
Method of measurement
Median nerve Ultra Sound evaluation images will obtain by a physical medicine specialist for all patients . Images will collect on the same day as Electrodiagnostic testing by using a Hitachi ( 2015-JAPAN-Arietta v 60 j ) equipped with an 18–5 MHz linear array transducer. The median nerve will image in cross section at the distal wrist crease (carpal tunnel inlet) . The cross-sectional area (CSA) was calculated using the continuous trace method by outlining the perimeter just inside the hyperechoic epineurium. Three measurements will be made for each person and the average will be considered for analysis.
3
Description
Visual Analogue Scale
Timepoint
For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months.
Method of measurement
The visual scale for measuring pain intensity is a 10 cm ruler with the word painless written on the left end and the word "most severe pain" written on the right end. Continuity marks. Note that they only mark one point. The amount of pain was measured by the researcher using the Visual-Linear Pain Scale (VAS), which is standardized for measuring pain. The linear-visual pain measurement scale is divided from zero to ten as follows:0-1: No pain, 2-3: Low pain, 4-5: High pain, 6-7: Very bad pain, 8-9: Maximum pain, 10: unbearable pain
4
Description
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Timepoint
For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analog Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months.
Method of measurement
The Boston questionnaire is self-applied and evaluates the severity of symptoms and the functional status of patients with carpal tunnel syndrome. The symptoms severity scale evaluates symptoms regarding severity, frequency, time and kind. The functional status scale evaluates how the syndrome affects daily life .Questions concerning symptoms severity scale are composed of 11questions addressing: pain intensity during daytime and nighttime, time of pain during the day, dormancy ,weakness, tingling sensation at night, frequency of that night tingling sensation, and skill. Each question has five answers numbered from 1 to 5, arranged in an increasing order of symptoms severity. Therefore, 1 means no symptoms, 2 mild symptoms, 3 moderate symptoms,4 intense symptoms, and 5 severe symptoms .Questions concerning functional status are composed of 8 questions, where each one corresponds to afunctional activity (writing, buttoning clothes, holding a book while reading, holding a telephone hang, housekeeping, opening a glass vial cap, carrying market bags, bathing and dressing).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection Also use a wrist splint for 6 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent. Also use a wrist splint for 6 weeks