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The short-term Effect of Physiotherapy in comparison to Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial

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History
# Registration date Revision Id
2 2022-12-11, 1401/09/20 250054
1 2022-03-21, 1401/01/01 220609
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  • Protocol summary

    The purpose of this study was to compare of the short term effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability and effectiveness of Treatment in patients with Frozen shoulder.
    The purpose of this study was to compare the short-term effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability and effectiveness of Treatment in patients with Frozen shoulder.
    Using stratified randomization, two indexes of numbers 1 and 2, which belong to physiotherapy (number 1) and injection (number 2), respectively, will be generated and put into opaque, sealed envelopes. one group of envelopes belongs to diabetic patients and the other group, to non diabetic patients. Based on the mean and standard deviation of the SPADI questionnaire score in similar Studies, 24 subjects in each group, with a 10% drop, are considered.
    This clinical trial is a randomized, superiority, parallel, blinded, multicenter study with 48 participants in two groups (24 in each group).
    با استفاده از تصادفی سازی طبقه ای، دو توالی 24 تایی از اعداد 1 و 2 که به ترتیب مربوط به گروه فیزیوتراپی و تزریق است، تولید شده و به ترتیب در پاکت های کدر، سر بسته و مهر موم شده قرار خواهد گرفت. یک مجموعه پاکت برای افراد دیابتی و یک مجموعه دیگر برای افراد غیر دیابتی است. بر اساس میانگین و انحراف معیار نمره پرسشنامه SPADI در مطالعات مشابه حجم نمونه 20 بدست می آید که با احتساب 10% ریزش، 24 نفر در هر گروه در نظر خواهیم گرفت
    این مطالعه بالینی، یک کار آزمایی تصادفی، برتری، موازی، کور سازی شده و چند مرکزی بر روی 48 بیمار (24 بیمار در هر گروه) است.
    Special Physiotherapy clinic of Qaem Hospital Orthopedics clinic of Imam Reza hospital Orthopedics clinic of Dr. Ali Moradi
    After the initial evaluation via the blinded assessor and randomization at Orthopedics clinic of Prof. Mohammad Hossein Ebrahim Zade, Physiotherapy group will receive the treatment at Special Physiotherapy clinic of Qaem Hospital. The injection group will receive the treatment at Orthopedics clinic of Prof. Mohammad Hossein Ebrahim Zade.
    کلنیک ویژه فیزیوتراپی بیمارستان قائم کلینیک ارتوپدی بیمارستان امام رضا مطب دکتر علی مرادی
    بعد از ارزیابی بیماران توسط معاینه کننده ی کور سازی شده و تصادفی سازی بیماران در مطب ارتوپدی پروفسور محمد حسین ابراهیم زاده، درمان گروه فیزیوتراپی در کلینیک ویژه فیزیوتراپی بیمارستان قائم انجام خواهد شد. درمان تزریق در مطب ارتوپدی پروفسور محمد حسین ابراهیم زاده انجام خواهد شد.
    After evaluation and assessing the inclusion and exclusion criteria, patients diagnosed with Frozen Shoulder will be allocated randomly into two groups of Injection and Physiotherapy.
    Inclusion criteria: Patients older than 18 years, Abduction and External rotation limitation (More than 50% of normal range), A minimum history of 4 weeks of Shoulder pain, Absence of coagulative diseases, Sleep disturbances due to pain and incapability of sleeping on the affected side. Exclusion criteria: History of severe trauma to the shoulder, History of neck radiculopathy, History of complete Rotator Cuff tear, Severe infection, History of Glenohumeral joint fracture, Presence of malignancy in Shoulder 4 to 6 months after Radiotherapy in Shoulder, Injection contraindications (Allergic to Drug, etc.)
    بعد از ارزیابی و بررسی معیار های ورود و خروج، بیماران مبتلا به شانه یخ زده به صورت تصادفی بین دو گروه تزریق و فیزیوتراپی تقسیم می شوند.
    معیار های ورود: بیماران بالای 18 سال، دامنه حرکتی کمتر از 50 درصد دامنه نرمال (ابداکشن و اکسترنال روتیشن)، سابقه درد شانه حداقل 4 هفته، نبود بیماری انعقادی، اختلالات خواب در شب به دلیل عدم توانایی خوابیدن بر روی شانه درگیر شده. معیار های خروج: سابقه تروما شدید به شانه، تاریخچه رادیکولوپاتی گردن، تاریخچه پارگی کامل عضلات روتاتورکاف، عفونت شدید، تاریخچه شکستگی در شانه، وجود بدخیمی در شانه، گذشت 4 تا 6 ماه از رادیوتراپی در شانه، کانتراندیکاسیون های تزریق ( آلرژی به دارو، عفونت های قارچی سیستمیک)
    In physiotherapy group, who will receive 10 Therapeutic sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser will be applied for 30 seconds in 8 painful points of the glenohumeral capsule with an energy amount of 1.8 joules per each point. Afterwards, a grade 2 glenohumeral mobilization for Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session. In injection group, 20 milligrams of Triamcinolone, half with the posterior glenohumeral approach (1.5 milliliters) and the other half with lateral subacromial approach, will be injected.
    Comprehensive physiotherapy with hot pack application, low level laser therapy, glenohumeral joint mobilizations and Proprioceptive neuromuscular facilitation techniques. Intra-articular Corticosteroid injection into the glenohumeral joint via the posterior approach.
    در گروه فیزیوتراپی که درمان 10 جلسه ای به صورت 3 جلسه در هفته را دریافت خواهند کرد، بعد از اعمال هات پک به مدت 15 دقیقه، لیزر کم توان به مدت 30 ثانیه در 8 نقطه دردناک کپسول مفصلی شانه همراه با انرژی 1.8 ژول در هر نقطه اعمال خواهد شد. پس از آن موبیلیزاسیون گرید 2 مفصل گلنوهومرال در جهت ابداکشن و اکسترنال روتیشن انجام خواهد شد. سپس الگوی دیاگونال دوم فلکشن در اندام فوقانی در دست درگیر به همراه تکنیک Hold-Relax به صورت 10 ثانیه انقباض عضله ی آنتاگونیست، 5 بار در هر جلسه انجام خواهد شد. در گروه تزریق، درمان تزریق 20 میلی گرم تریامسینولون به صورت تزریق نیمی از محلول (1.5 میلی لیتر) با روش خلفی مفصل گلنوهومرال و نیمه ی دیگر محلول (1.5 میلی لیتر) با روش خارجی ناحیه ساب آکرومیال انجام می شود.
    فیزیوتراپی جامع با استفاده از هات پک، لیزر کم توان، تکنیک های متحرک سازی مفصل گلنوهومرال و تکنیک های تسهیل عمقی عصبی-عضلانی. تزریق درون مفصلی با روش خلفی در مفصل گلنوهومرال.
    1. VAS 2. SPADI questionnaire 3. GRC scale
    Pain via the Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI); Disability via SPADI; The effectiveness of treatment via the Global Rate of Change (GRC) scale.
    1. مقیاس بصری درد 2. پرسشنامه SPADI 3. مقیاس GRC
    درد با استفاده از مقیاس بصری درد و پرسشنامه SPADI؛ میزان ناتوانی با استفاده از پرسشنامه SPADI؛ میزان اثر بخشی درمان با استفاده از مقیاس GRC.

  • General information

    Single blinded
    Double blinded
    1
    empty
    Procedural Change (Drug dosage), Allocation and randomization location change, minor changes and clarification in execution.
    empty
    تغییر روش کار (دوز دارو)، تغییر محل گروه بندی و ارزیابی، تغییرات جزئی در روش کار، شفاف سازی جزئیات اجرایی
    The short term Effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial
    The short-term Effect of Physiotherapy in comparison to Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial
    Patients older than 18 years
    Abduction and External rotation limitation (More than 50%)
    History of at least 4 weeks of Shoulder pain
    Absence of coagulative diseases
    Sleep disturbances due to pain
    Patients older than 18 years
    Abduction and External rotation limitation (More than 50% of normal range)
    A minimum history of 4 weeks of Shoulder pain
    Absence of coagulative diseases
    Sleep disturbances due to pain and incapability of sleeping on the affected side
    Participants will choose from sealed, opaque envelopes. Another physiotherapist who is not aware of the allocation will evaluate the patients.
    Using stratified randomization, two indexes of numbers 1 and 2, which belong to physiotherapy (number 1) and injection (number 2), respectively, will be generated from "sealedenvelope.com" and put into opaque, sealed envelopes. one group of envelopes belongs to diabetic patients and the other group, to non-diabetic patients. Based on the mean and standard deviation of the SPADI questionnaire score in similar Studies, while considering a 10% drop rate, 24 subjects will be allocated to each group.
    شرکت کنندگان به تصادف یکی از پاکت های مهر و موم شده و کدر را انتخاب می کنند. فیزیوتراپیست دیگری که از نحوه گروه بندی اطلاعی ندارد بیماران را ارزیابی خواهد کرد.
    با استفاده از تصادفی سازی طبقه ای، دو توالی از اعداد 1 و 2 که به ترتیب مربوط به گروه فیزیوتراپی و تزریق است، با استفاده از سایت "sealedenvelope.com" تولید شده و به ترتیب در پاکت های کدر، سر بسته و مهر موم شده قرار خواهد گرفت. یک مجموعه پاکت برای افراد دیابتی و یک مجموعه دیگر برای افراد غیر دیابتی است. بر اساس میانگین و انحراف معیار نمره پرسشنامه SPADI در مطالعات مشابه حجم نمونه 22 بدست می آید که با احتساب 10% ریزش، 24 نفر در هر گروه در نظر خواهیم گرفت
    Assessing the outcome will be performed by another practitioner who is unaware of the allocation process. Statistical analyzer will be blinded for data analysis.
    Participants will choose from sealed, opaque envelopes. Another physiotherapist who is not aware of the allocation will evaluate the patients in a separate room. Data analyser will be blinded when performing statistical analysis using codes A and B for intervention groups in the statistical analysis software.
    بررسی پیامد ها به وسیله درمان گر دیگری که از گروه بندی ها بی اطلاع است، انجام خواهد شد. کور سازی آنالیز گر آماری برای بررسی داده ها انجام خواهد شد.
    شرکت کنندگان به تصادف یکی از پاکت های مهر و موم شده و کدر را انتخاب می کنند. فیزیوتراپیست دیگری که از نحوه گروه بندی اطلاعی ندارد بیماران را در اتاقی جداگانه ارزیابی خواهد کرد. کور سازی تحلیل گر آماری با استفاده از کد های A و B برای داده های گروه ها انجام خواهد شد.

  • Health conditions studied

    #1
    Adhesive capsulitis of shoulder
    Adhesive capsulitis of shoulder (Frozen Shoulder)
    شانه یخ زده
    التهاب چسبنده کپسول شانه (شانه یخ زده)

  • Primary outcomes

    #1
    Visual Analog Scale
    Shoulder Pain and Disability Index (SPADI) questionnaire, Visual Analogue Scale
    مقیاس بصری درد
    پرسشنامه ی شاخص درد و ناتوانی شانه، مقیاس بصری درد
    #2
    Disability
    empty
    ناتوانی
    empty
    Immediately After Allocation, 6 weeks after Randomization
    empty
    بلافاصله بعد از تقسیم کردن به گروه ها، 6 هفته بعد از تصادفی سازی
    empty
    SPADI questionnaire
    empty
    توسط پرسشنامه SPADI
    empty
    #3
    The Effectiveness of Treatment
    empty
    میزان اثر گذاری درمان
    empty
    6 weeks after randomization
    empty
    6 هفته بعد از تصادفی سازی
    empty
    Global Rating Scale
    empty
    توسط مقیاس رتبه ای سراسری
    empty

  • Secondary outcomes

    #1
    empty
    Disability
    empty
    ناتوانی
    empty
    Immediately After Allocation, 6 weeks after Randomization
    empty
    بلافاصله بعد از تقسیم کردن به گروه ها، 6 هفته بعد از تصادفی سازی
    empty
    Shoulder Pain and Disability Index (SPADI) questionnaire
    empty
    پرسشنامه ی شاخص درد و ناتوانی شانه
    #2
    empty
    The Effectiveness of Treatment
    empty
    میزان اثر گذاری درمان
    empty
    6 weeks after randomization
    empty
    6 هفته بعد از تصادفی سازی
    empty
    Global Rating of Change Scale
    empty
    مقیاس رتبه ای سراسری

  • Intervention groups

    #1
    Intervention group: In physiotherapy group, who will receive 10 Therapeutic sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser will be applied for 30 seconds in 8 painful points of the glenohumeral capsule with an energy amount of 1.8 joules per each point. Afterwards, a grade 2 glenohumeral mobilization for Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session
    Intervention group: In physiotherapy group, who will receive 10 sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser with 1.8 joules of energy per point will be applied for 30 seconds on 8 painful points of the glenohumeral capsule. Afterwards, a grade 2 glenohumeral mobilization for improving Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session.
    #2
    Control group: 20 milligrams of Triamcinolone, half with the posterior glenohumeral approach (1.5 milliliters) and the other half with lateral subacromial approach, will be injected.
    Control group: 40 milligrams of Triamcinolone (1 Milliliter) and 9 Millilitres of 2 percent Lidocaine, will be injected into glenohumeral joint via posterior approach
    گروه کنترل: درمان تزریق 20 میلی گرم تریامسینولون به صورت تزریق نیمی از محلول (1.5 میلی لیتر) با روش خلفی مفصل گلنوهومرال و نیمه ی دیگر محلول (1.5 میلی لیتر) با روش خارجی ناحیه ساب آکرومیال انجام می شود.
    گروه کنترل: درمان تزریق 40 میلی گرم تریامسینولون به حجم 1 میلی لیتر و 9 میلی لیتر لیدوکائین 2 درصد به صورت تزریق درون مفصلی در مفصل گلنوهومرال با روش خلفی انجام خواهد شد

  • Recruitment centers

    #1
    Name of recruitment center - English: Physical Therapy Clinic of Qaem Hospital
    Name of recruitment center - Persian: کلینیک ویژه فیزیوتراپی بیمارستان قائم
    Full name of responsible person - English: Mr. Javad Zarandi
    Full name of responsible person - Persian: آقای جواد زرندی
    Street address - English: Nursing door entrance, right side, library side, Narjes building, first floor,Physiotherapy Department, Ghaem Hospital,
    Street address - Persian: بیمارستان قائم، دپارتمان فیزیوتراپی،ورودی درب پرستار،سمت راست،کنار کتابخانه ،ساختمان نرجس، طبقه اول
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9176699199
    Phone: +98 51 3841 1538
    Fax:
    Email: zarandiMJ1@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Physical Therapy Clinic of Qaem Hospital
    Name of recruitment center - Persian: کلینیک ویژه فیزیوتراپی بیمارستان قائم
    Full name of responsible person - English: Mr. Javad Zarandi
    Full name of responsible person - Persian: آقای جواد زرندی
    Street address - English: Narjes building, first floor, Physiotherapy Department, Qaem Hospital, Nurse Street.
    Street address - Persian: خیابان پرستار، بیمارستان قائم، دپارتمان فیزیوتراپی، ساختمان نرجس، طبقه اول.
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9176699199
    Phone: +98 51 3841 1538
    Fax:
    Email: zarandiMJ1@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Majid Ghayour Mobarhan
    Full name of responsible person - Persian: دکتر مجید غیور مبرهن
    Street address - English: Doctora Cross road, Ghoreshi Building
    Street address - Persian: چهارراه دکترا جنب سینما هویزه، ساختمان قرشی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9919191778
    Phone: +98 51 3841 1538
    Fax:
    Email: vcresearch@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Majid Ghayour Mobarhan
    Full name of responsible person - Persian: دکتر مجید غیور مبرهن
    Street address - English: Ghoreshi Building, Doctora Crossroad.
    Street address - Persian: چهارراه دکترا جنب سینما هویزه، ساختمان قریشی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9919191778
    Phone: +98 51 3841 1538
    Fax:
    Email: vcresearch@mums.ac.ir
    Web page address:
    Personal Grant (Dr Salman Nazary-Moghadam)
    Personal Grant (Dr. Salman Nazary-Moghadam)

  • Sharing plan

    Nazary_salman@yahoo.com
    mohammadalizare6@gmail.com
    Nazary_salman@yahoo.com
    mohammadalizare6@gmail.com

Protocol summary

Study aim
The purpose of this study was to compare the short-term effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability and effectiveness of Treatment in patients with Frozen shoulder.
Design
This clinical trial is a randomized, superiority, parallel, blinded, multicenter study with 48 participants in two groups (24 in each group).
Settings and conduct
After the initial evaluation via the blinded assessor and randomization at Orthopedics clinic of Prof. Mohammad Hossein Ebrahim Zade, Physiotherapy group will receive the treatment at Special Physiotherapy clinic of Qaem Hospital. The injection group will receive the treatment at Orthopedics clinic of Prof. Mohammad Hossein Ebrahim Zade.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years, Abduction and External rotation limitation (More than 50% of normal range), A minimum history of 4 weeks of Shoulder pain, Absence of coagulative diseases, Sleep disturbances due to pain and incapability of sleeping on the affected side. Exclusion criteria: History of severe trauma to the shoulder, History of neck radiculopathy, History of complete Rotator Cuff tear, Severe infection, History of Glenohumeral joint fracture, Presence of malignancy in Shoulder 4 to 6 months after Radiotherapy in Shoulder, Injection contraindications (Allergic to Drug, etc.)
Intervention groups
Comprehensive physiotherapy with hot pack application, low level laser therapy, glenohumeral joint mobilizations and Proprioceptive neuromuscular facilitation techniques. Intra-articular Corticosteroid injection into the glenohumeral joint via the posterior approach.
Main outcome variables
Pain via the Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI); Disability via SPADI; The effectiveness of treatment via the Global Rate of Change (GRC) scale.

General information

Reason for update
Procedural Change (Drug dosage), Allocation and randomization location change, minor changes and clarification in execution.
Acronym
IRCT registration information
IRCT registration number: IRCT20161221031506N8
Registration date: 2022-03-21, 1401/01/01
Registration timing: prospective

Last update: 2022-12-24, 1401/10/03
Update count: 1
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Salman Nazary-Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6713
Email address
nazaryms@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The short-term Effect of Physiotherapy in comparison to Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial
Public title
Comparison of Drug Injection and Physiotherapy in patients diagnosed with Frozen Shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years Abduction and External rotation limitation (More than 50% of normal range) A minimum history of 4 weeks of Shoulder pain Absence of coagulative diseases Sleep disturbances due to pain and incapability of sleeping on the affected side
Exclusion criteria:
History of severe trauma to the shoulder History of neck radiculopathy History of complete Rotator Cuff tear Severe infection History of Glenohumeral joint fracture Presence of malignancy in Shoulder 4 to 6 months after Radiotherapy in Shoulder Injection contraindications (Allergic to Drug, etc.)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Using stratified randomization, two indexes of numbers 1 and 2, which belong to physiotherapy (number 1) and injection (number 2), respectively, will be generated from "sealedenvelope.com" and put into opaque, sealed envelopes. one group of envelopes belongs to diabetic patients and the other group, to non-diabetic patients. Based on the mean and standard deviation of the SPADI questionnaire score in similar Studies, while considering a 10% drop rate, 24 subjects will be allocated to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will choose from sealed, opaque envelopes. Another physiotherapist who is not aware of the allocation will evaluate the patients in a separate room. Data analyser will be blinded when performing statistical analysis using codes A and B for intervention groups in the statistical analysis software.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Science's Research and Development Deputy Office, Across 18th University Street, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.MUMS.REC.1400.345

Health conditions studied

1

Description of health condition studied
Adhesive capsulitis of shoulder (Frozen Shoulder)
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Pain
Timepoint
Immediately After Allocation, 6 weeks after Randomization
Method of measurement
Shoulder Pain and Disability Index (SPADI) questionnaire, Visual Analogue Scale

Secondary outcomes

1

Description
Disability
Timepoint
Immediately After Allocation, 6 weeks after Randomization
Method of measurement
Shoulder Pain and Disability Index (SPADI) questionnaire

2

Description
The Effectiveness of Treatment
Timepoint
6 weeks after randomization
Method of measurement
Global Rating of Change Scale

Intervention groups

1

Description
Intervention group: In physiotherapy group, who will receive 10 sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser with 1.8 joules of energy per point will be applied for 30 seconds on 8 painful points of the glenohumeral capsule. Afterwards, a grade 2 glenohumeral mobilization for improving Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session.
Category
Rehabilitation

2

Description
Control group: 40 milligrams of Triamcinolone (1 Milliliter) and 9 Millilitres of 2 percent Lidocaine, will be injected into glenohumeral joint via posterior approach
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Therapy Clinic of Qaem Hospital
Full name of responsible person
Mr. Javad Zarandi
Street address
Narjes building, first floor, Physiotherapy Department, Qaem Hospital, Nurse Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 1538
Email
zarandiMJ1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour Mobarhan
Street address
Ghoreshi Building, Doctora Crossroad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Personal Grant (Dr. Salman Nazary-Moghadam)
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
Mohammadalizare6@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
mohammadalizare6@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
mohammadalizare6@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be reported in the form of a research article. Raw data will be delivered to researchers for meta analysis.
When the data will become available and for how long
6 months after publication
To whom data/document is available
For researchers only.
Under which criteria data/document could be used
For meta-analysis Only.
From where data/document is obtainable
mohammadalizare6@gmail.com
What processes are involved for a request to access data/document
The response will be sent 3 within months after considering the researcher's request.
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