History
# Registration date Revision Id
2 2019-09-21, 1398/06/30 128818
1 2017-06-27, 1396/04/06 2633
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    This study is designed to compare the effectiveness of a reduction knee adduction moment exercise (etiologic-based exercise) and conventional strengthening exercises on biomechanical and clinical measures in individuals with Knee osteoarthritis. Thirty patients with knee osteoarthritis, who have been referred by a rheumatologist to Mowafaghian Research Center of Intelligent Neuro-Rehabilitation Technologies, allocate into strengthening training or etiologic-based exercise groups randomly. Inclusion criteria included having mild to moderate chronic osteoarthritis of tibiofemoral joint and 45-76 years old. Reporting other diseases and use of invasive treatments in the lower extremities consider as exclusion criteria. After signing the consent form both groups receive an educational leaflet, continues ultrasound therapy, hot pack, TENS and exercises protocol. The treatment will be performed 3 times a week for 4 weeks. Strengthening training include flexion and extension exercise of knee joint with the quadriceps chair. The etiologic-based exercise includes medial thrust gait and maintaining goddess and warrior postures. All measurements will be performed by a blind assessor to the groups of study before and after intervention and one month after intervention. The measurements include: pain by means of a visual analogue scale and the short WOMAC scale, functional activity by the 2 minute walking test and knee adduction moment by means the tree-dimensional motion analysis and two force plates.
    empty
    این مطالعه به مقایسه اثربخشی تمرینات کاهنده گشتاور اداکتوری زانو (علت - محور) و تمرینات تقویتی بر پیامدهای بیومکانیکی و بالینی استئوآرتریت زانو می پردازد. 30 بیمار مبتلا به استئوآرتریت که توسط روماتولوژیست به مرکز تحقیقات فناوریهای توانبخشی عصبی هوشمند موفقیان ارجاع شده اند، به صورت تصادفی به دو گروه تمرینات علت - محور و تمرینات تقویتی تقسیم می شوند. شاخص های ورود به مطالعه شامل ابتلا به استئوآرتریت مزمن مفصل تيبيوفمورال دارای شدت ملايم تا متوسط و سن بين 45 تا 76 سال می شود. ابتلا به بيماريهای دیگر استفاده از درمانهاي تهاجمي دراندام تحتاني شرایط خروج از مطالعه می باشد. یعد از امضای رضایتنامه هر دو گروه تحت درمان با آموزش، TENS، اولتراسوند درمانی، hot pack و تمرین درمانی قرار می گیرند. درمان به مدت 4 هفته و هر هفته 3 جلسه انجام می شود. تمرینات تقویتی شامل تمرینات فلکشن و اکستنشن زانو روی صندلی کوادریسپس می شود. تمرینات علت-محور نیز شامل راه رفتن medial thrust و حفظ حالت الاهه و جنگاور می شود. اندازه گیری ها توسط یک فرد کور به مطالعه قبل، بعد و یک ماه بعد از مطالعه انجام می شود. اندازه گیری ها شامل مقیاس دیداری درد و مقیاس short WOMAC برای درد و تست دو دقیقه راه رفتن برای فعالیت عملکردی می شود. گشتاور اداکتوری زانو نیز توسط تحلیل سه بعدی حرکت و دو صفحه نیرو اندازه گیری می شود.
    empty
    empty
    This study is designed to compare the effectiveness of a reduction knee adduction moment exercise (etiologic-based exercise) and conventional exercises on biomechanical and clinical measures in individuals with Knee osteoarthritis.
    empty
    این مطالعه به مقایسه اثربخشی تمرینات کاهنده گشتاور اداکتوری زانو (علت - محور) و تمرینات مرسوم بر پیامدهای بیومکانیکی و بالینی استئوآرتریت زانو می پردازد.
    empty
    This study was a randomized, double-blind, parallel-design clinical trial.
    empty
    این مطالعه یک کارآزمایی بالینی، با گروه های موازی، دو سویه کور، تصادفی شده است.
    empty
    This study compares three methods of exercise therapy in patients with knee osteoarthritis.Patients at Djavad Mowafaghian research center of intelligent neuro-rehabilitation technologies are treated for one month with one of the exercise methods. All measurements will be performed by a blind assessor to the groups of study before and after intervention and one month after intervention.Patients and data analysts were also blind.
    empty
    این مطالعه به مقایسه سه روش تمرین درمانی در بیماران مبتلا به استئوآرتریت زانو می پردازد. بیماران در مرکز تحقیقات فناوری های توانبخشی عصبی هوشمند جواد موفقیان به مدت یک ماه با یکی از روش های تمرینی درمان شدند. اندازه گیری ها توسط یک فرد کور به مطالعه قبل، بعد و یک ماه بعد از مطالعه انجام شد. بیماران و تحلیل کننده داده ها نیز کور بودند.
    empty
    Inclusion criteria included having mild to moderate chronic osteoarthritis of tibiofemoral joint and 45-76 years old. Reporting other diseases and use of invasive treatments in the lower extremities consider as exclusion criteria.
    empty
    شاخص های ورود به مطالعه شامل ابتلا به استئوآرتریت مزمن مفصل تيبيوفمورال دارای شدت ملايم تا متوسط و سن بين 45 تا 76 سال می شود. ابتلا به بيماريهای دیگر استفاده از درمانهاي تهاجمي دراندام تحتاني شرایط خروج از مطالعه می باشد.
    empty
    1. Intervention group 1: treated by education, ultrasound therapy, hot pack, electrostimulator (TENS) and yoga exercise and medial thrust gait training For 4 weeks and 3 sessions per week 2. Intervention group 2: treated by education, ultrasound therapy, hot pack, TENS and quadriceps and hamstring strength training For 4 weeks and 3 sessions per week 3. Intervention group 3: treated by education, ultrasound therapy, hot pack, TENS and walking exercise For 4 weeks and 3 sessions per week
    empty
    1. گروه مداخله 1: تحت درمان با آموزش، تحریک الکتریکی، اولتراسوند درمانی، پک داغ و تمرینات یوگا و تمرین راه رفتن مدیال تراست به مدت 4 هفته و هر هفته 3 جلسه 2. گروه مداخله 2: تحت درمان با آموزش، تحریک الکتریکی، اولتراسوند درمانی، پک داغ و تمرینات تقویتی کوادیسپس و همسترینگ به مدت 4 هفته و هر هفته 3 جلسه 3. گروه مداخله 3: تحت درمان با آموزش، تحریک الکتریکی، اولتراسوند درمانی، پک داغ و تمرین راه رفتن به مدت 4 هفته و هر هفته 3 جلسه
    empty
    Anterior knee pain; functional activity during gait; knee joint loading during gait.
    empty
    درد در قدام زانو؛ فعالیت عملکردی حین راه رفتن؛ بارگذاری مفصل زانو حین راه رفتن.
  • General information

    1
    1
    1
    N/A
    empty
    27
    empty
    2017-07-23, 1396/05/01
    empty
    2018-09-11, 1397/06/20
    empty
    2018-10-12, 1397/07/20
    empty
    Adding a new treatment group; Following the publication of the study protocol, experts suggested that a new treatment group with only normal walking exercise be added to the study to ensure control of the results of the study.
    empty
    افزودن یک گروه درمانی جدید؛ پس از انتشار پروتکل مطالعه صاحب نظران پیشنهاد دادند که یک گروه درمانی جدید که فقط دارای ورزش راه رفتن معمولی باشد نیز به مطالعه افزوده شود تا از کنترل شده بودن نتایج مطالعه اطمینان حاصل شود.
    Comparison of an etiologic-based exercise and conventional strengthening exercises on knee loading in individuals with Knee osteoarthritis.
    Comparison of an etiologic-based exercise and conventional exercises on knee loading in individuals with Knee osteoarthritis.
    مقایسه تمرینات علت محور و تمرینات تقویتی متداول بر بارگذاری مفصل زانو در مبتلایان به استئوآرتریت زانو
    مقایسه تمرینات علت محور و تمرینات مرسوم بر بارگذاری مفصل زانو در مبتلایان به استئوآرتریت زانو
    Comparison of effectiveness of an etiologic-based exercise and conventional strengthening exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
    Comparison of effectiveness of an etiologic-based exercise and conventional exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
    مقایسه اثربخشی تمرینات علت محور و تمرینات تقویتی متداول بر بارگذاری مفصل زانو، درد و فعالیت عملکردی در مبتلایان به استئوآرتریت زانو - یک کارآزمایی بالینی
    مقایسه اثربخشی تمرینات علت محور و تمرینات مرسوم بر بارگذاری مفصل زانو، درد و فعالیت عملکردی در مبتلایان به استئوآرتریت زانو - یک کارآزمایی بالینی
    having mild to moderate chronic osteoarthritis of unilaterally or bilaterally tibiofemoral joint according to the method of Kellgren and Lawrance
    45-76 years old
    a history of symptoms more than a month
    being able to walk without assistant devices
    having the recent anterior and lateral x-ray image of knee
    ابتلا به استئوآرتریت مزمن مفصل تيبيوفمورال بصورت يك طرفه يا دو طرفه و دارای شدت ملايم تا متوسط با استفاده از متد Kellgren and Lawrance
    سن بين 45 تا 76 سال
    علائم بيش از يك ماه
    توانایی راه رفتن بدون استفاده از وسايل كمكي
    داشتن تصویر راديوگرافي روبرو و طرفی زانو جدید
    Reporting other diseases such as: diabetes, diseases of musculoskeletal, neuromuscular and uncontrolled diseases of cardiovascular, respiratory and uncontrolled hypertension
    the use of injections or other invasive treatments (such as surgery) in the lower extremities during the last three months
    having an artificial hip or knee joints
    taking painkiller
    history of trauma to knee joint during last week
    performing regular professional exercise
    extreme physical weakness
    ابتلا به بيماريهایی نظیر: ديابت، بيماريهاي عضلانی - اسكلتي، عصبي- عضلاني و بیماری های قلبي- عروقي، تنفسي و فشار خون کنترل نشده
    استفاده ازتزريق يا ديگر درمانهاي تهاجمي (مثل جراحي) دراندام تحتاني طي سه ماه گذشته
    بيماران داراي مفصل زانو يا ران مصنوعي
    مصرف داروهای مسکن
    سابقه ضربه و تروما به مفصل زانو طي يك هفته قبل
    سابقه فعاليت ورزشي منظم به صورت حرفه اي
    ضعف جسماني شديد
    empty
    The volunteers were divided among the treatment groups by using the closed envelopes.The closed were only available to a technician at the research center who was not a part of the research team.After the pre-treatment evaluation, patients were asked to select one envelope from a box containing several envelopes. After opening the envelope, the patient was referred to the therapist based on the patient's group number to begin treatment. Than the covariate adaptive randomization technique was used for group assignment ensuring a balanced assignment of participants over the covariates of pain severity, the K-L score, age and body mass index.
    empty
    داوطلبان با استفاده از روش پاکت در بسته در میان گروه های درمانی تقسیم شدند. پاکت های در بسته تنها در دسترس یک تکنسین مرکز تحقیقات که عضوی از تیم تحقیق نبود قرار داشت. بعد از ارزیابی پیش از درمان از بیماران خواسته می شد که از جعبه حاوی چندین پاکت دربسته یکی را انتخاب کند. بعد از باز شدن پاکت بر اساس شماره گروه بیمار برای شروع درمان به درمانگر معرفی می شد. سپس از روش تصادفی سازگاری متغیرها برای تعیین گروهی استفاده شد برای اطمینان از توزیع متعادل گروهی از نظر متغیرهای شدت درد، نمره مقیاس K-L، سن و شاخص توده بدنی.
    empty
    Results were evaluated by a person who was not involved in the study design. She was only aware of the participants' illnesses and the consequences that need to be measured. So outcome assessor were blinded to the study purpose, number of groups, and treatment differences. She was also unaware of any patient group. The data analyzer was entered into the research group after completing the study. He was blind to all aspects of the study including purpose, groups, and treatments and he identified treatment groups as groups 1, 2 and 3 without recognizing the differences.
    empty
    برای ارزیابی پیامدها از فردی که در جریان طراحی مطالعه حضور نداشت استفاده شد. او تنها در مورد بیماری شرکت کنندگان و پیامدهایی بود که باید سنجید اطلاعات داشت. بنابراین ارزیابی کننده پیامدها نسبت به هدف مطالعه، تعداد گروه ها و تفاوت درمان ها کور بود. او همچنین از گروه درمانی هر بیمار ناآگاه بود. آنالیز کننده داده ها پس از انجام کامل مطالعه به گروه تحقیق وارد شد. او نسبت به تمام وجوه مطالعه از جمله هدف، گروه ها و درمان ها کور بود و گروه های درمان را بدون شناخت تفاوت ها تنها به صورت گروه های 1 ،2 و 3 می شناخت.
    empty
    empty
  • Ethics committees

    #1
    IR.AJUMS.REC.1396..317
    IR.AJUMS.REC.1396.317
  • Intervention groups

    #1
    intervention group: Patients will be treated for 4 weeks and 3 sessions per week by electrical stimulation, educational leaflet, continues ultrasoundtherapy, hot pack and strengthening training include flexion and extension exercise of knee joint.
    Intervention group 1: Patients treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set yoga exercise and 20 minute medial thrust gait training.
    گروه مداخله: بیماران به مدت 4 هفته و هر هفته 3 جلسه تحت درمان با تحریکات الکتریکی، آموزش، اولتراسوند درمانی، پک داغ و تمرینات تقویتی شامل فلکشن و اکستنشن زانو قرار خواهند گرفت.
    گروه مداخله1: بیماران به مدت 4 هفته و هر هفته 3 جلسه تحت درمان با 20 دقیقه تحریکات الکتریکی، آموزش، 5 دقیقه اولتراسوند درمانی پیوسته، پک داغ و 3 مرحله تمرینات یوگا و 20 دقیقه تمرینات راه رفتن مدیال تراست قرار گرفتند.
    #2
    Other
    Treatment - Other
    intervention group: Patients will be treated for 4 weeks and 3 sessions per week by electrical stimulation, educational leaflet, continues ultrasoundtherapy, hot pack and etiologic-based exercise includes medial thrust gait and maintaining goddess and warrior postures.
    Intervention group 2: Patients treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set quadriceps and hamstring strength training by the resistance flexion and extension knee exercise.
    گروه مداخله: بیماران به مدت 4 هفته و هر هفته 3 جلسه تحت درمان با تحریکات الکتریکی، آموزش، اولتراسوند درمانی، پک داغ و تمرینات علت محور شامل راه رفتن با فشار داخلی و حفظ حالت الاهه و جنگاور قرار خواهند گرفت.
    گروه مداخله 2: بیماران به مدت 4 هفته و هر هفته 3 جلسه تحت درمان با 20 دقیقه تحریکات الکتریکی، آموزش، 5 دقیقه اولتراسوند درمانی پیوسته، پک داغ و 3 مرحله تمرینات تقویتی کوادریسپس و همسترینگ به صورت تمرین خم و راست شدن مقاومتی زانو قرار گرفتند.
    #3
    empty
    Treatment - Other
    empty
    Intervention group: Patients will be treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 20 minute walking exercise on treadmill.
    empty
    گروه مداخله 3: بیماران به مدت 4 هفته و هر هفته 3 جلسه تحت درمان با 20 دقیقه تحریکات الکتریکی، آموزش، 5 دقیقه اولتراسوند درمانی پیوسته، پک داغ و 20 دقیقه تمرینات راه رفتن بر روی تردمیل قرار می گیرند.
  • Recruitment centers

    #1
    Name of recruitment center - English: Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies
    Name of recruitment center - Persian: مرکز تحقیقات فناوریهای توانبخشی عصبی هوشمند موفقیان
    Full name of responsible person - English: Dr. Farahmand
    Full name of responsible person - Persian: دکتر فرهمند
    Street address - English: No 11, Khark Street, Enghelab Street
    Street address - Persian: خیابان انقلاب، خیابان خارک، پلاک 11
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies
    Name of recruitment center - Persian: مرکز تحقیقات فناوریهای توانبخشی عصبی هوشمند موفقیان
    Full name of responsible person - English: Dr. Farahmand
    Full name of responsible person - Persian: دکتر فرهمند
    Street address - English: No 11, Khark Street, Enghelab Street
    Street address - Persian: خیابان انقلاب، خیابان خارک، پلاک 11
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 13813-11339
    Phone: +98 21 6671 6100
    Fax:
    Email: contact@sharifrehab.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Makhmalzadeh
    Full name of responsible person - Persian: دکتر مخمل زاده
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Makhmalzadeh
    Full name of responsible person - Persian: دکتر مخمل زاده
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 15794-61357
    Phone: +98 61 3311 1111
    Fax:
    Email: info@ajums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: Faculty member
    Position - Persian: عضو هیئت علمی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3161
    Mobile: 00
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: Faculty member
    Position - Persian: عضو هیئت علمی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15794-61357
    Phone: +98 61 3161
    Mobile: +98 916 313 2795
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: fuclty member
    Position - Persian: عضو هیئت علمی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3161
    Mobile: 00
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: fuclty member
    Position - Persian: عضو هیئت علمی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15794-61357
    Phone: +98 61 3161
    Mobile: +98 916 313 2795
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: fuclty member
    Position - Persian: عضو هیئت علمی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3161
    Mobile:
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Zahednejad
    Full name of responsible person - Persian: دکتر زاهدنژاد
    Position - English: fuclty member
    Position - Persian: عضو هیئت علمی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
    Street address - Persian: گلستان، خیابان اسفند، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15794-61357
    Phone: +98 61 3161
    Mobile: +98 916 313 2795
    Fax:
    Email: dr.shzahed@gmail.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    na
    undecided
    undecided
    undecided
    na
    empty
    I need to consult with the research team.
    empty
    نیاز به مشورت با تیم تحقیقات دارم.

Protocol summary

Study aim
This study is designed to compare the effectiveness of a reduction knee adduction moment exercise (etiologic-based exercise) and conventional exercises on biomechanical and clinical measures in individuals with Knee osteoarthritis.
Design
This study was a randomized, double-blind, parallel-design clinical trial.
Settings and conduct
This study compares three methods of exercise therapy in patients with knee osteoarthritis.Patients at Djavad Mowafaghian research center of intelligent neuro-rehabilitation technologies are treated for one month with one of the exercise methods. All measurements will be performed by a blind assessor to the groups of study before and after intervention and one month after intervention.Patients and data analysts were also blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria included having mild to moderate chronic osteoarthritis of tibiofemoral joint and 45-76 years old. Reporting other diseases and use of invasive treatments in the lower extremities consider as exclusion criteria.
Intervention groups
1. Intervention group 1: treated by education, ultrasound therapy, hot pack, electrostimulator (TENS) and yoga exercise and medial thrust gait training For 4 weeks and 3 sessions per week 2. Intervention group 2: treated by education, ultrasound therapy, hot pack, TENS and quadriceps and hamstring strength training For 4 weeks and 3 sessions per week 3. Intervention group 3: treated by education, ultrasound therapy, hot pack, TENS and walking exercise For 4 weeks and 3 sessions per week
Main outcome variables
Anterior knee pain; functional activity during gait; knee joint loading during gait.

General information

Reason for update
Adding a new treatment group; Following the publication of the study protocol, experts suggested that a new treatment group with only normal walking exercise be added to the study to ensure control of the results of the study.
Acronym
IRCT registration information
IRCT registration number: IRCT201702222793N4
Registration date: 2017-06-27, 1396/04/06
Registration timing: prospective

Last update: 2020-04-09, 1399/01/21
Update count: 1
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Shahla Zahednejad
Name of organization / entity
School Of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3102
Email address
snejad@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-09-11, 1397/06/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
Comparison of effectiveness of an etiologic-based exercise and conventional exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
Public title
Comparison of an etiologic-based exercise and conventional exercises on knee loading in individuals with Knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having mild to moderate chronic osteoarthritis of unilaterally or bilaterally tibiofemoral joint according to the method of Kellgren and Lawrance 45-76 years old a history of symptoms more than a month being able to walk without assistant devices having the recent anterior and lateral x-ray image of knee
Exclusion criteria:
Reporting other diseases such as: diabetes, diseases of musculoskeletal, neuromuscular and uncontrolled diseases of cardiovascular, respiratory and uncontrolled hypertension the use of injections or other invasive treatments (such as surgery) in the lower extremities during the last three months having an artificial hip or knee joints taking painkiller history of trauma to knee joint during last week performing regular professional exercise extreme physical weakness
Age
From 45 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 27
Randomization (investigator's opinion)
Randomized
Randomization description
The volunteers were divided among the treatment groups by using the closed envelopes.The closed were only available to a technician at the research center who was not a part of the research team.After the pre-treatment evaluation, patients were asked to select one envelope from a box containing several envelopes. After opening the envelope, the patient was referred to the therapist based on the patient's group number to begin treatment. Than the covariate adaptive randomization technique was used for group assignment ensuring a balanced assignment of participants over the covariates of pain severity, the K-L score, age and body mass index.
Blinding (investigator's opinion)
Double blinded
Blinding description
Results were evaluated by a person who was not involved in the study design. She was only aware of the participants' illnesses and the consequences that need to be measured. So outcome assessor were blinded to the study purpose, number of groups, and treatment differences. She was also unaware of any patient group. The data analyzer was entered into the research group after completing the study. He was blind to all aspects of the study including purpose, groups, and treatments and he identified treatment groups as groups 1, 2 and 3 without recognizing the differences.
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC.1396.317

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Primary gonarthrosis, bilateral

Primary outcomes

1

Description
Knee joint loading
Timepoint
pre and post treatment and 1 month after treatment
Method of measurement
assesment of knee aduction moment by 3D motion analysis and force plate

Secondary outcomes

1

Description
functional activity
Timepoint
pre and post intervention and one month after intervention
Method of measurement
using of 2 minute walking test

2

Description
pain
Timepoint
study pre and post intervention and one month after intervention
Method of measurement
using of visual analogue scale and the short WOMAC scale

Intervention groups

1

Description
Intervention group 1: Patients treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set yoga exercise and 20 minute medial thrust gait training.
Category
Treatment - Other

2

Description
Intervention group 2: Patients treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 3 set quadriceps and hamstring strength training by the resistance flexion and extension knee exercise.
Category
Treatment - Other

3

Description
Intervention group: Patients will be treated for 4 weeks and 3 sessions per week by 20 minute electrical stimulation, educational leaflet, 5 minute continuous ultrasound therapy, hot pack and 20 minute walking exercise on treadmill.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies
Full name of responsible person
Dr. Farahmand
Street address
No 11, Khark Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
13813-11339
Phone
+98 21 6671 6100
Email
contact@sharifrehab.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 1111
Email
info@ajums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
fuclty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
fuclty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Not applicable
Loading...