Comparison of the efectiveness of Radial Extracorporeal Shock wave Therapy and corticosteroid injection of piriformis muscle for treatment patients suffering of piriformis syndrome
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Protocol summary
Clinical trial with intervention and control group with sample size in each group of 14 patients and 28 persons in total, in parallel group, single blind, randomized with closed envelope
Clinical trial with intervention and control group with a sample size of 35 people, in parallel group, single blind, randomized with closed envelope
Clinical trial with intervention and control group with a sample size in each group of 14 patients and 28 persons in total35 people, in parallel group, single blind, randomized with closed envelope
کارآزمایی بالینی دارای گروه مداخله و کنترل با حجم نمونه در هر گروه 14 نفر و در مجموع 28 نفر، بصورت گروه موازی، یک سویه کور، تصادفی شده با بلوك هاي تصادفي
کارآزمایی بالینی دارای گروه مداخله و کنترل با حجم نمونه 35 نفر، بصورت گروه موازی، یک سویه کور، تصادفی شده با بلوك هاي تصادفي
کارآزمایی بالینی دارای گروه مداخله و کنترل با حجم نمونه در هر گروه 14 نفر و در مجموع 2835 نفر، بصورت گروه موازی، یک سویه کور، تصادفی شده با بلوك هاي تصادفي
General information
28
35
2835
empty
According to similar studies, we increased the sample size of the study.
According to similar studies, we increased the sample size of the study.
empty
با توجه به مطالعات مشابه، حجم نمونه مطالعه را افزایش دادیم.
با توجه به مطالعات مشابه، حجم نمونه مطالعه را افزایش دادیم.
Simple randomization, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 28 people, 6 quadruple blocks and 2 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable.
Simple randomization, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 35 people, 8 quadruple blocks and 1 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable.
Simple randomization, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 2835 people, 68 quadruple blocks and 21 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable.
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 28 نفره، 6 بلوک چهارتایی و 2 بلوك دوتايي با استفاده از روش جايگشتها توليد و شماره گذاري خواهند شد. با استفاده از جدول اعداد تصادفي بلوكها در كنار يكديگر 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 خواهند بود و همچنین توالی تصادفی تولید شده در طول مطالعه از پیش بینی مصون خواهد بود.
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 35 نفره، 8 بلوک چهارتایی و 1 بلوك دوتايي با استفاده از روش جايگشتها توليد و شماره گذاري خواهند شد. با استفاده از جدول اعداد تصادفي بلوكها در كنار يكديگر 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 خواهند بود و همچنین توالی تصادفی تولید شده در طول مطالعه از پیش بینی مصون خواهد بود.
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 2835 نفره، 68 بلوک چهارتایی و 21 بلوك دوتايي با استفاده از روش جايگشتها توليد و شماره گذاري خواهند شد. با استفاده از جدول اعداد تصادفي بلوكها در كنار يكديگر 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 خواهند بود و همچنین توالی تصادفی تولید شده در طول مطالعه از پیش بینی مصون خواهد بود.
Primary outcomes
#1
Baseline, 7, 60, and 90 days after Intervention
Baseline, 7, 30, 60, and 90 days after Intervention
Baseline, 7, 30, 60, and 90 days after Intervention
ابتدای مطالعه، 7، 60 و 90 روز پس از انجام مداخله
ابتدای مطالعه، 7، 30، 60 و 90 روز پس از انجام مداخله
ابتدای مطالعه، 7، 30، 60 و 90 روز پس از انجام مداخله
#2
Baseline, 7, 60 and 90 days after Intervention
Baseline and 30 days after Intervention
Baseline, 7, 60 and 9030 days after Intervention
ابتدای مطالعه، 7، 60 و 90 روز پس از انجام مداخله
ابتدای مطالعه و 30 روز پس از انجام مداخله
ابتدای مطالعه، 7، 60 و 9030 روز پس از انجام مداخله
Short Form (36) health survey questionnaire
36-Item Short Form Survey (SF-36) questionnaire
36-Item Short Form Survey (SF-36) health survey questionnaire
پرسشنامه فرم کوتاه (36) بررسی سلامت
پرسشنامه فرم کوتاه (36) بررسی کیفیت زندگی
پرسشنامه فرم کوتاه (36) بررسی سلامتکیفیت زندگی
Recruitment centers
#1
Name of recruitment center - English: Firoozgar hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Arastoo yousefi
Full name of responsible person - Persian: ارسطو یوسفی
Street address - English: Firoozgar Hospital, Beh afrin Ave, Karim Khan Street, Tehran, Iran
Street address - Persian: تهران، کریم خان، خیابان به آفرین، بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1600
Fax:
Email: h_firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: Firoozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Arastoo Yousefi
Full name of responsible person - Persian: ارسطو یوسفی
Street address - English: Firoozgar Hospital, Beh Afrin Ave, Karim Khan Street, Tehran, Iran
Street address - Persian: تهران، کریم خان، خیابان به آفرین، بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1229
Fax:
Email: arastoo.yousefi@gmail.com
Web page address:
Name of recruitment center - English: Firoozgar hospitalHospital Name of recruitment center - Persian: بیمارستان فیروزگر Full name of responsible person - English: Arastoo yousefiYousefi Full name of responsible person - Persian: ارسطو یوسفی Street address - English: Firoozgar Hospital, Beh afrinAfrin Ave, Karim Khan Street, Tehran, Iran Street address - Persian: تهران، کریم خان، خیابان به آفرین، بیمارستان فیروزگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1593747811 Phone: +98 21 8214 16001229 Fax: Email: h_firoozgararastoo.yousefi@yahoo.comgmail.com Web page address:
#2
Name of recruitment center - English: Rasoul-e-Akram hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Arastoo yousefi
Full name of responsible person - Persian: ارسطو یوسفی
Street address - English: Rasoul-e-Akram Hospital, Niayesh Ave., Sattarkhan, Tehran, Iran
Street address - Persian: تهران، ستارخان، خیابان نیایش، بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 86701
Fax:
Email: iumspr@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul-e-Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Arastoo Yousefi
Full name of responsible person - Persian: ارسطو یوسفی
Street address - English: Rasoul-e-Akram Hospital, Niayesh Ave., Sattarkhan, Tehran, Iran
Street address - Persian: تهران، ستارخان، خیابان نیایش، بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 8214 1229
Fax:
Email: arastoo.yousefi@gmail.com
Web page address:
Name of recruitment center - English: Rasoul-e-Akram hospitalHospital Name of recruitment center - Persian: بیمارستان رسول اکرم Full name of responsible person - English: Arastoo yousefiYousefi Full name of responsible person - Persian: ارسطو یوسفی Street address - English: Rasoul-e-Akram Hospital, Niayesh Ave., Sattarkhan, Tehran, Iran Street address - Persian: تهران، ستارخان، خیابان نیایش، بیمارستان رسول اکرم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 867018214 1229 Fax: Email: iumsprarastoo.yousefi@iums.ac.irgmail.com Web page address:
Protocol summary
Study aim
Comparison of Extracorporeal Shock Wave Therapy Radial Muscle Effect with Corticosteroid Injection for the Treatment of Patients with Preforms Syndrome
Design
Clinical trial with intervention and control group with a sample size of 35 people, in parallel group, single blind, randomized with closed envelope
Settings and conduct
The study population is patients referred to physical medicine and rehabilitation clinics of Firoozgar and Rasoul Akram hospitals in Tehran. Patients are examined by a specialist in physical medicine and rehabilitation and entered into the plan if necessary. This study is a randomized, single-blind clinical trial that is divided into two groups by randomized closed envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Chronic pain in Batuk at least 3 months
Age over 20 years
Their pain intensity should be at least 5 out of 10 according to the Visual Analogue Scale criteria
Exclusion criteria:
Symptoms of lumbar discus
Have a pregnancy or pregnancy plan
Have a history of disc surgery
Intervention groups
Shock therapy group and corticosteroid injection group
Main outcome variables
Severity of pain; quality of life
General information
Reason for update
According to similar studies, we increased the sample size of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20191027045252N1
Registration date:2020-01-10, 1398/10/20
Registration timing:registered_while_recruiting
Last update:2020-12-23, 1399/10/03
Update count:1
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Arastoo Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 9437
Email address
arastoo.yousefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efectiveness of Radial Extracorporeal Shock wave Therapy and corticosteroid injection of piriformis muscle for treatment patients suffering of piriformis syndrome
Public title
Comparison of the efficacy of in vivo shock therapy with corticosteroid injection in the treatment of piriformis syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic pain in Batuk, thigh and lower extremity for at least 3 months
Patients must be over 20 years of age
Screening of all patients for lumbar disc herniation and lumbar radiculopathy by MRI.
Their pain intensity should be at least 5 out of 10 according to the Visual Analogue Scale criteria
Exclusion criteria:
Symptoms of lumbar discus, coxopathy, mechanical or inflammatory disorders of the sacroiliac joint
Any inflammatory, infectious, or pelvic abnormalities
Have a pregnancy or pregnancy plan
Have a history of disc surgery and any epidural block over the past 6 months.
Patients who do not go for follow-up for any reason.
Changes in the patient's treatment according to the physician's opinion or other treatment by the patient during the study
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 35 people, 8 quadruple blocks and 1 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the difference in the nature of the therapeutic intervention in the two groups, only the data analyzer will be blind.
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, Next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-09-23, 1398/07/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.234
Health conditions studied
1
Description of health condition studied
Piriformis syndrome
ICD-10 code
G57.0
ICD-10 code description
Lesion of sciatic nerve
Primary outcomes
1
Description
Severity of pain
Timepoint
Baseline, 7, 30, 60, and 90 days after Intervention
Method of measurement
Visual Analogue Scale
2
Description
Quality of Life
Timepoint
Baseline and 30 days after Intervention
Method of measurement
36-Item Short Form Survey (SF-36) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing shockwave therapy, three sessions, each lasting 7 to 10 days. Shockwave is performed with the Storz Medical Shock Wave MP100. Each session of shockwave therapy with 2000 pulses and a total of 6000 pulses in three sessions, energy flux density equal to 0.18 mJ / mm², 5 Hz frequency, 4 bar pressure rate, Dose per treatment equal to 0.18 mJ / mm2 = 2,000 360 mJ / mm2 and Total energy dose (TED) equal to 1.080 J / mm2.
Category
Treatment - Devices
2
Description
Control group: Patients treated with 40 mg methylprednisolone plus 1 cc lidocaine 1% undergo sonography in the piriformis muscle.