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General information
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54
54
2020-06-08, 1399/03/19
2020-01-09, 1398/10/19
2020-0601-0809 00:00:00
empty
2019-12-12, 1398/09/21
2019-12-12 00:00:00
empty
2019-12-18, 1398/09/27
2019-12-18 00:00:00
empty
2020-06-18, 1399/03/29
2020-06-18 00:00:00
empty
A few days before 2019-12-10, I had requested for expected recruitment date to be on 2019-12-10. but unfortunately my request was accepted two days later and now the chief editor wants to know if I started my clinical trial 2 days sooner! but I didn`t. I started it exactly on 2019-12-12 after getting confirmation. the reason was busy schedule of the person who confirmed the registration on 12th . I forgot to write down the achieved date of starting my clinical trial and now I want to update that. thanks
A few days before 2019-12-10, I had requested for expected recruitment date to be on 2019-12-10. but unfortunately my request was accepted two days later and now the chief editor wants to know if I started my clinical trial 2 days sooner! but I didn`t. I started it exactly on 2019-12-12 after getting confirmation. the reason was busy schedule of the person who confirmed the registration on 12th . I forgot to write down the achieved date of starting my clinical trial and now I want to update that. thanks
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با عرض سلام. بنده چندروز قبل از 19م آذر 98 درخواست شروع بیمارگیری را برای این تاریخ ثبت کردم. اما متاسفانه به علت حجم بالای درخواست همکاران، درخواست بنده در 21م همان ماه تایید گردید و بلافاصله از همان روز 21م کارآزمایی را شروع کردم. در حال حاضر سردبیر مجله ای که مقاله را برایشان فرستادم ایراد گرفته اند که چرا شروع بیمارگیری 19م ثبت شده. درحالی که 19م صرفا تاریخ مورد انتظار بوده نه تاریخ تحقق یافته. بنده از 21م شروع کردم و در حال حاضر علت بروزرسانی بنده درخواست ثبت تاریخ تحقق یافته است. با تشکر
با عرض سلام. بنده چندروز قبل از 19م آذر 98 درخواست شروع بیمارگیری را برای این تاریخ ثبت کردم. اما متاسفانه به علت حجم بالای درخواست همکاران، درخواست بنده در 21م همان ماه تایید گردید و بلافاصله از همان روز 21م کارآزمایی را شروع کردم. در حال حاضر سردبیر مجله ای که مقاله را برایشان فرستادم ایراد گرفته اند که چرا شروع بیمارگیری 19م ثبت شده. درحالی که 19م صرفا تاریخ مورد انتظار بوده نه تاریخ تحقق یافته. بنده از 21م شروع کردم و در حال حاضر علت بروزرسانی بنده درخواست ثبت تاریخ تحقق یافته است. با تشکر
Recruitment centers
#1
Name of recruitment center - English: Rasoul akram hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم (ص)
Full name of responsible person - English: ِDR Arash Babaei
Full name of responsible person - Persian: دکتر آرش بابایی
Street address - English: Rasoul akram hospital, Niayesh street, Satarkhan Ave
Street address - Persian: خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6435 2683
Fax:
Email: arashbabaie@gmail.com
Web page address: http://hrmc.iums.ac.ir/form_contact.php?sid=44&slc_lang=fa
Name of recruitment center - English: Rasoul-akram hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم (ص)
Full name of responsible person - English: ِDr. Arash Babaei-Ghazani
Full name of responsible person - Persian: دکتر آرش بابایی غازانی
Street address - English: Phsical medicine department- Rasoul-akram hospital- Niayesh street- Satarkhan Ave- Tehran, Iran.
Street address - Persian: خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم (ص)، بخش طب فیزیکی و توانبخشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2683
Fax:
Email: arashbabaie@gmail.com
Web page address: http://hrmc.iums.ac.ir/form_contact.php?sid=44&slc_lang=fa
Name of recruitment center - English: Rasoul-akram hospital Name of recruitment center - Persian: بیمارستان رسول اکرم (ص) Full name of responsible person - English: ِDRDr. Arash Babaei-Ghazani Full name of responsible person - Persian: دکتر آرش بابایی غازانی Street address - English: Phsical medicine department- Rasoul-akram hospital,- Niayesh street,- Satarkhan Ave- Tehran, Iran. Street address - Persian: خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم (ص)، بخش طب فیزیکی و توانبخشی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۵۶۱۳۱۳۱1445613131 Phone: +98 21 6435 2683 Fax: Email: arashbabaie@gmail.com Web page address: http://hrmc.iums.ac.ir/form_contact.php?sid=44&slc_lang=fa
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: ِDr seyed kazem malakooti
Full name of responsible person - Persian: دکتر سید کاظم ملکوتی
Street address - English: Iran university of medical sciences, hemmat autobahn
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: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 2503
Fax:
Email: research@iums.ac.ir
Web page address: http://vcr.iums.ac.ir/page/3340/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: ِDr. seyed Abbas Motevalian
Full name of responsible person - Persian: دکتر سید عباس متولیان
Street address - English: Iran university of medical sciences, hemmat autobahn
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: 1445613131
Phone: +98 21 8670 2503
Fax:
Email: amotevalian@iums.ac.ir
Web page address: http://vcr.iums.ac.ir/page/3340/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: ِDr. seyed kazem malakootiAbbas Motevalian Full name of responsible person - Persian: دکتر سید کاظم ملکوتیعباس متولیان Street address - English: Iran university of medical sciences, hemmat autobahn 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: ۱۴۴۹۶۱۴۵۳۵1445613131 Phone: +98 21 8670 2503 Fax: Email: researchamotevalian@iums.ac.ir Web page address: http://vcr.iums.ac.ir/page/3340/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Protocol summary
Study aim
Comparison of the effectiveness of local corticosteroid injection with injection of dextrose 5% solution in patients with carpal tunnel syndrome.
Design
Double blinded randomized control trial.
Settings and conduct
This study will be conducted on physical medicine and rehabilitation department of Rasool Akram hospital, Tehran, Iran. Patients with mild to moderate carpal tunnel syndrome (based on electrodiagnostic study) will be included in the study. Patients will be categorized into one of the following groups, using block randomization method:
A Group: Will receive ultrasound-guided injection of 1CC triamcinolone into carpal tunnel.
B Group: Will receive ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel.
Patients in the both groups will receive the conservative treatments for carpal tunnel syndrome including wrist splints for six weeks as well.
Patients will be followed after 2 weeks, one month and 6 months after injections. The pain intensity (Visual analogue scale) and the electrodiagnostic parameters are the main outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Clinical diagnosis of carpal tunnel syndrome based on history (paresthesia over the distribution of median nerve) and possitive Tinnel and Phalen's tests.
2- Mild to moderate severity based on electrodiagnostic study.
3- Age between 18-65 years.
exclusion criteria:
Severe CTS, thenar atrophy, contraindication for injection, previous treatment , Neoplasm or trauma,tenderness and fracture of wrist, cervical radiculopathy, polyneuropathy.
Intervention groups
A Group: Ultrasound-guided injection of 1CC triamcinolone into carpal tunnel.
B Group: Ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel.
Main outcome variables
Pain intensity (Visual analogue scale) and the electrodiagnostic parameters.
General information
Reason for update
A few days before 2019-12-10, I had requested for expected recruitment date to be on 2019-12-10. but unfortunately my request was accepted two days later and now the chief editor wants to know if I started my clinical trial 2 days sooner! but I didn`t. I started it exactly on 2019-12-12 after getting confirmation. the reason was busy schedule of the person who confirmed the registration on 12th . I forgot to write down the achieved date of starting my clinical trial and now I want to update that. thanks
Acronym
CTS
IRCT registration information
IRCT registration number:IRCT20180603039969N1
Registration date:2019-12-12, 1398/09/21
Registration timing:registered_while_recruiting
Last update:2020-07-13, 1399/04/23
Update count:1
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Sara Moradnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 1210
Email address
moradnia.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-10, 1398/09/19
Expected recruitment end date
2020-01-09, 1398/10/19
Actual recruitment start date
2019-12-12, 1398/09/21
Actual recruitment end date
2019-12-18, 1398/09/27
Trial completion date
2020-06-18, 1399/03/29
Scientific title
Comparison of the effectiveness of ultrasound-guided local corticosteroid injection with dextrose 5% solution injection in carpal tunnel syndrome.
Public title
Comparison of effectiveness of corticosteroid with dextrose in treatment of carpal tunnel syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with clinical diagnosis of carpal tunnel syndrome (paresthesia over the median nerve territory in the hand).
Mild to moderate severity of carpal tunnel syndrome, based on electrodiagnostic studies.
Age between 18-65 years,
Exclusion criteria:
Severe CTS ( based on electrodiagnostic data).
Signs of thenar atrophy.
Contraindication for injection ( such as history of hypersensitivity to corticosteroid, signs of local infection, immune deficiency, needle phobia.
Diseases that mimic symptoms of carpal tunnel syndrome such as polyneuropathy, radiculopathy, and thoracic outlet syndrome.
Surgical treatment or local injection in the last six months.
Neoplastic or traumatic origin.
Tenderness and fracture of wrist bones.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be categorized into one of the following groups, using block randomization method:
Group A) Will receive ultrasound-guided injection of 1 ml triamcinolone (40 mg) into the carpal tunnel.
Group B) Will receive ultrasound-guided injection of 5 ml dextrose 5% into the carpal tunnel.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the investigator are kept blinded. The injecting syringe is covered with sterile gas. Therefore, the investigator will be kept blinded to the type of injecting solution. Furthermore, the patient will be kept blinded to the type of injecting solution.
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
Ethics committee, medical school, Iran University of Medical Sciences, Hemmat highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.IUMS.FMD.REC.1397.216
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
Pain intensity (Visual analogue scale)
Timepoint
Baseline, and after 2 weeks, one month and 6 months after injection.
Method of measurement
10 point VAS scale.
2
Description
Electrodiagnosis parameters
Timepoint
Baseline, and after 2 weeks, one month and 6 months after injection.
Method of measurement
Electrodiagnostic study machine
Secondary outcomes
empty
Intervention groups
1
Description
One session of ultrasound-guided 1 CC Triamcinolone (Exir co, Tehran, Iran) injection into the carpal tunnel.
Category
Treatment - Drugs
2
Description
One session of ultrasound-guided 5 CC dextrose 5% solution (Ghazi co, Tehran, Iran) injection into the carpal tunnel.