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1 2024-01-09, 1402/10/19 291262
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  • Protocol summary

    General aim Investigating the effect of 10 treatment sessions of mulligan technique along with common physiotherapy in the knee joint on disability, pain and kinematic and spatiotemporal characteristics of walking in people with knee osteoarthritis referring to hospitals and clinics affiliated to Iran University of Medical Sciences.
    General aim Investigating the effect of 10 treatment sessions of mulligan technique along with common physiotherapy in the knee joint on disability, pain and kinematic and spatiotemporal characteristics of walking and electromyographic activity of muscles during gait, sit to stand and static balance in people with knee osteoarthritis
    هدف کلی بررسی تاثیر10 جلسه درمان تکنیک موبیلیزیشن همراه حرکت همراه با فیزیوتراپی معمول در مفصل زانو بر ناتوانی، درد و ویژگی‌های کینماتیکی و فضایی - زمانی راه‌رفتن در افراد مبتلا به آرتروز زانو مراجعه کننده به بیمارستان ها و کلینیک های وابسته به دانشگاه علوم پزشکی ایران
    هدف کلی بررسی تاثیر10 جلسه درمان تکنیک موبیلیزیشن همراه حرکت همراه با فیزیوتراپی معمول در مفصل زانو بر ناتوانی، درد و ویژگی‌های کینماتیکی و فضایی - زمانی راه‌رفتن، فعالیت الکترومایوگرافیک عضلات در راه رفتن، برخواستن ازنشسته و تعادل ایستا در افراد مبتلا به آرتروز زانو مراجعه کننده به بیمارستان ها و کلینیک های وابسته به دانشگاه علوم پزشکی ایران
    First, the participants will be evaluated in the biomechanics laboratory, the subject and the examiner will be blind to the grouping and the examiner will not be present in the treatment process, then the examinees will receive 10 treatment sessions in the hospitals and clinics affiliated to the Iran University of Medical Sciences, then again will be evaluated in the laboratory
    First, the participants will be evaluated in the biomechanics laboratory, the subject and the examiner will be blind to the grouping and the examiner will not be present in the treatment process, then the examinees will receive 10 treatment sessions in the hospitals and clinics affiliated to the Iran University of Medical Sciences, then again will be evaluated in the laboratory.
    ابتدا شرکت کنندگان درآزمایشگاه بیومکانیک مورد ارزیابی قرار خواهند گرفت آزمودنی و آزمونگر نسبت به گروهبندی کور خواهند بود و آزمونگر در روند درمان حضور نخواهد داشت سپس آزموندنی ها در بیمارستان ها و کلینیک های وابسته به دانشگاه علوم پزشکی ایران 10 جلسه درمان دریافت خواهند کرد سپس دوباره در آزمایشگاه ارزیابی خواهند شد
    ابتدا شرکت کنندگان درآزمایشگاه بیومکانیک مورد ارزیابی قرار خواهند گرفت آزمودنی و آزمونگر نسبت به گروهبندی کور خواهند بود و آزمونگر در روند درمان حضور نخواهد داشت سپس آزموندنی ها در بیمارستان ها و کلینیک های وابسته به دانشگاه علوم پزشکی ایران 10 جلسه درمان دریافت خواهند کرد سپس دوباره در آزمایشگاه ارزیابی خواهند شد. سپس گروه مداخله تحت 12 جلسه راه رفتن همراه با تحریک الکتریکی عضلات قرار خواهد گرفت.
    - Age 40 to 70 years -Diagnosis of knee tibiofemoral joint arthrosis based on American College of Rheumatology criteria by a specialist doctor -Pain intensity based on visual pain t scale between 4 and 8 while walking at the time of evaluation - The severity of arthritis should be based on Kellgren and Lawrence classification system, 2 and 3 - Ability to walk more than 6 meters -Pain of one-sided arthritis of the tibiofemoral joint of the knee (even if a person has bilateral arthritis, a knee that is painful will be included in the study) - Having knee pain for more than 3 months
    - Age 40 to 70 years -Diagnosis of knee tibiofemoral joint arthrosis based on American College of Rheumatology criteria -Pain intensity (VAS) between 4 and 8 while walking at the time of evaluation - The severity of OA on K-L classification system, 2 and 3 - Ability to walk more than 6 meters -Pain of one-sided of the knee (even if a person has bilateral arthritis, a knee that is painful will be included in the study) - knee pain for more than 3 months
    In the treatment group, the participants will receive the common physiotherapy of knee arthrosis with the Mulligan technique, and in the control group they will receive the common physiotherapy of the knee arthrosis with the Mulligan technique in an artificial form.
    In the treatment group, the participants will receive the common physiotherapy of knee arthrosis with the Mulligan technique, and in the control group they will receive the common physiotherapy of the knee arthrosis with the Mulligan technique in an artificial form. After 10 sessions of physiotherapy, the intervention group will receive electrical muscle stimulation along with walking for 12 sessions.
    در گروه درمان شرکت کنندگان فیزیوتراپی معمول ارتروز زانو همراه با تکنیک مولیگان را دریافت خواهند نمود ودر گروه کنترل فیزیوتراپی معمول ارتروز زانو همراه با تکنیک مولیگان به صورت بدلی را دریافت خواهند نمود
    در گروه درمان شرکت کنندگان فیزیوتراپی معمول ارتروز زانو همراه با تکنیک مولیگان را دریافت خواهند نمود ودر گروه کنترل فیزیوتراپی معمول ارتروز زانو همراه با تکنیک مولیگان به صورت بدلی را دریافت خواهند نمود. پس از ده جلسه فیزیوتراپی گروه مداخله تحریک الکتریکی عضلات را همراه راه رفتن به مدت 12 جلسه دریافت خواهد کرد.
  • General information

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    2024-05-29, 1403/03/09
    2024-08-30, 1403/06/09
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    2024-01-29, 1402/11/09
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    2024-10-30, 1403/08/09
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    2024-12-29, 1403/10/09
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    Completion and termination of sampling and addition of outcome and the second phase of the intervention, which was approved by the ethics committee.
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    تکمیل و خاتمه نمونه گیری و اضافه کردن پیامد و فاز دوم مداخله که مورد تایید کمیته اخلاق قرار گرفت.
  • Ethics committees

    #1
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    2023-10-29, 1402/08/07
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    IR.IUMS.REC.1402.668
  • Secondary outcomes

    #1
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    Characteristics of electromyographic activity of muscles during gait, sit to stand and static balance
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    ویژگی‌های فعالیت الکترومایوگرافیک عضلات در فعالیت راه رفتن، برخواستن از حالت نشسته و تعادل ایستا
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    Measurement of variables at the beginning of the study and after 10 sessions of physiotherapy treatment and after 12 sessions of home-based walking training.
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    اندازه گیری متغیرها در ابتدای مطالعه و پس از 10 جلسه درمان فیزیوتراپی و پس از 12 جلسه تمرین راه رفتن در منزل
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    Kistler force plates and Myon electromyography system
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    فورس پلیت کیستلر، الکترومایوگرافی مایون
  • Intervention groups

    #1
    Intervention group: Intervention group: The participants in this group will receive10 treatment sessions during 4 weeks with at least one day between sessions by a therapist who is proficient in the Mulligan technique and regular physical therapy. The treatment in each group lasts for 60 minutes and includes 3 phases of preparation, exercise therapy and manual treatments. The first phase, preparation: in this phase, subjects will receive high-frequency electrical nerve surface stimulation for 20 minutes and infra red for 15 minutes. 4 electrodes are placed inside wet pads around the knee joint (two electrodes on the medial of the knee above and below the joint line and two electrodes on the lateral of the knee above and below the joint line) and will be tightened by the strap. The frequency and pulse duration used will be 110 Hz and 50 microseconds, respectively. The second phase, exercise therapy: The exercise therapy for these people will be in the form of strengthening exercises, stretching exercises, and range of motion exercises. Strengthening exercises include isotonic contraction with the help of varying leg weights of the knee extensor and hip abductor muscles, respectively, in sitting positions on the edge of the bed and lying on the side while the painful knee is elevated, with a frequency of 3 sessions per week according to the ability of the subject with The intensity of 60% to 80% of 1RM will include 2 to 4 sets of 8 to 15 sets, and between each set we will allocate 30 to 60 seconds of rest time to the subjects. We will use stretching exercises and active range exercises for muscle shortening or reducing the range of motion that disrupts the person's performance. Stretching exercises will be performed for 30 seconds in 3 sets of 10 for the biceps and hamstring muscles, and active and passive range of motion exercises will be performed in the form of movement from fully bent knee to fully straightened knee in 3 sets of 10. will get The third phase, manual treatments: At first, we will perform these exercises while lying on the back with the knees slightly bent. If the subject does not have pain in bending or straightening the knee while lying on the back, we will perform this technique for the subject while standing. gave Also, if after a few treatment sessions, the examiner does not have pain in bending and straightening his knee while lying on his back, we will follow the technique while standing. The treatment process will be like this, lying on the back with a slightly bent knee, we will ask the subject to actively bend and straighten the knee, then after placing hands around the knee joint, the subject's leg will be internally rotated, respectively. We will perform external rotation, internal glide, external glide, anterior glide and posterior glide and at the same time we will ask the subject to move his knee in the same painful direction and if the active movement of the subject that was painful before with any of the rotations or glides It was done without pain, we will use the same rotation or glide to continue the treatment. This technique should be performed without pain or with minimal pain, and if the pain decreases but does not reach zero, the therapist will reach a completely pain-free state by increasing or decreasing the applied pressure or applying additional pressure at the end of the range. This technique will be performed in the first session as a set of 6 and in the following sessions, according to the subject's ability, as 3 to 5 sets of 6 to 10. To perform the technique in a standing position, the subject will place the sole of the foot whose knee is painful on a stool at a height of 30 cm ; Then we will take active knee bending and straightening movements by applying internal and external rotations, internal and external glides, and anterior and posterior glides to the subject's leg. If the rotations do not hurt, we will continue the painful movement with the same rotation or glide for the subject.
    Intervention group: Intervention group: The participants in this group will receive10 treatment sessions during 4 weeks with at least one day between sessions by a therapist who is proficient in the Mulligan technique and regular physical therapy. The treatment in each group lasts for 60 minutes and includes 3 phases of preparation, exercise therapy and manual treatments. The first phase, preparation: in this phase, subjects will receive high-frequency electrical nerve surface stimulation for 20 minutes and infra red for 15 minutes. 4 electrodes are placed inside wet pads around the knee joint (two electrodes on the medial of the knee above and below the joint line and two electrodes on the lateral of the knee above and below the joint line) and will be tightened by the strap. The frequency and pulse duration used will be 110 Hz and 50 microseconds, respectively. The second phase, exercise therapy: The exercise therapy for these people will be in the form of strengthening exercises, stretching exercises, and range of motion exercises. Strengthening exercises include isotonic contraction with the help of varying leg weights of the knee extensor and hip abductor muscles, respectively, in sitting positions on the edge of the bed and lying on the side while the painful knee is elevated, with a frequency of 3 sessions per week according to the ability of the subject with The intensity of 60% to 80% of 1RM will include 2 to 4 sets of 8 to 15 sets, and between each set we will allocate 30 to 60 seconds of rest time to the subjects. We will use stretching exercises and active range exercises for muscle shortening or reducing the range of motion that disrupts the person's performance. Stretching exercises will be performed for 30 seconds in 3 sets of 10 for the biceps and hamstring muscles, and active and passive range of motion exercises will be performed in the form of movement from fully bent knee to fully straightened knee in 3 sets of 10. will get The third phase, manual treatments: At first, we will perform these exercises while lying on the back with the knees slightly bent. If the subject does not have pain in bending or straightening the knee while lying on the back, we will perform this technique for the subject while standing. gave Also, if after a few treatment sessions, the examiner does not have pain in bending and straightening his knee while lying on his back, we will follow the technique while standing. The treatment process will be like this, lying on the back with a slightly bent knee, we will ask the subject to actively bend and straighten the knee, then after placing hands around the knee joint, the subject's leg will be internally rotated, respectively. We will perform external rotation, internal glide, external glide, anterior glide and posterior glide and at the same time we will ask the subject to move his knee in the same painful direction and if the active movement of the subject that was painful before with any of the rotations or glides It was done without pain, we will use the same rotation or glide to continue the treatment. This technique should be performed without pain or with minimal pain, and if the pain decreases but does not reach zero, the therapist will reach a completely pain-free state by increasing or decreasing the applied pressure or applying additional pressure at the end of the range. This technique will be performed in the first session as a set of 6 and in the following sessions, according to the subject's ability, as 3 to 5 sets of 6 to 10. To perform the technique in a standing position, the subject will place the sole of the foot whose knee is painful on a stool at a height of 30 cm ; Then we will take active knee bending and straightening movements by applying internal and external rotations, internal and external glides, and anterior and posterior glides to the subject's leg. If the rotations do not hurt, we will continue the painful movement with the same rotation or glide for the subject. Secondary intervention description: After completion 10 sessions of the physiotherapy intervention, participants will be re-randomized, such that an equal number of participants from each group will be allocated to the intervention and control groups. In this study, the knee joint with more severe symptoms will be selected for assessment of muscle activation and fitting of the unloader knee brace. In cases where symptom severity is equal in both knees, the dominant knee will be selected. Both groups will use the brace daily for 1 to 8 hours and will perform twelve 30-minute walking sessions over a four-week period. The control group will use the unloader knee brace without electrical stimulation, whereas the NMES group will receive neuromuscular electrical stimulation concurrently with gait during walking. Stimulation intensity will be adjusted based on patient feedback up to the maximum tolerable level, such that painless muscle contractions are elicited, and participants will be encouraged to gradually increase the stimulation intensity. Electrode placement will be instructed by a physiotherapist, and patient adherence will be monitored through weekly follow-ups and adherence forms.
    گروه مداخله: شرکت کنندگان در این گروه توسط درمانگر مسلط به تکنیک مولیگان و فیزیوتراپی معمول، ده جلسه درمان طی چهار هفته با حداقل یک روز فاصله بین جلسات دریافت خواهند کرد.درمان در هر گروه به مدت 60 دقیقه و شامل 3 فاز آماده‌سازی، تمرین درمانی و درمان‌های دستی خواهد بود. فاز اول، آماده سازی: در این مرحله آزمودنی‌ها تحریک الکتریکی سطحی عصب فرکانس بالا به مدت 20 دقیقه و مادون قرمز به مدت 15دقیقه دریافت خواهند کرد. 4 الکترود داخل پدهای مرطوب دور مفصل زانو ( دو الکترود در قسمت داخلی زانو در بالا و پایین خط مفصلی و دو الکترود در قسمت خارجی زانو در بالا و پایین خط مفصلی) قرار گرفته و توسط استرپ سفت خواهند شد. بسامد و طول موج مورد استفاده به ترتیب 110 هرتز و 50 میکروثانیه خواهد بود .فاز دوم، تمرین درمانی: تمرین درمانی در این افراد به صورت تمرینات تقویتی، تمرینات کششی و تمرینات دامنه حرکتی خواهند بود. تمرینات تقویتی شامل انقباض ایزوتونیک با کمک وزنه پا متغیر از عضلات صاف کننده زانو و دورکننده هیپ به ترتیب در حالت‌های نشسته لبه‌ی تخت و خوابیده به پهلو در حالی که زانوی دردناک بالا قرار گرفته باشد با فرکانس 3 جلسه در هفته با توجه به توانایی آزمودنی با شدت 60% تا 80% 1RM شامل 2 تا 4 ست 8 تا 15 تایی خواهند بود و بین هر ست 30 تا 60 ثانیه زمان استراحت به آزمودنی‌ها اختصاص خواهیم داد . برای کوتاهی عضلانی و یا کاهش دامنه‌ی حرکتی‌ای که عملکرد فرد را مختل می کند ، تمرینات کششی و تمرینات دامنه‌ی فعال بکار خواهیم برد. تمرینات کششی به مدت 30 ثانیه به تعداد 3 ست 10 تایی برای عضلات دوقلو ساق پا و عضله همسترینگ انجام خواهدگرفت و تمرینات دامنه‌ی حرکتی فعال و غیر فعال به صورت حرکت از حالت خم کامل زانو به حالت صاف کامل زانو به صورت 3 ست 10 تایی انجام خواهند گرفت. فاز سوم، درمان‌های دستی : در ابتدا این تمرینات را در حالت خوابیده به پشت با کمی خم بودن زانو انجام خواهیم داد .اگر آزمودنی در حالت خوابیده به پشت در خم یا صاف کردن زانو دردی نداشت این تکنیک را در حالت ایستاده برای آزمودنی انجام خواهیم داد. همچنین اگر بعد چند جلسه درمان در حالت خوابیده به پشت آزمونگر دیگر درد در خم و صاف کردن زانویش در این حالت نداشت تکنیک را در حالت ایستاده دنبال خواهیم کرد. روند درمان اینگونه خواهد بود که در حالت خوابیده به پشت با زانوی کمی خم از آزمودنی خواهیم خواست حرکات خم و صاف کردن زانو را به صورت فعال انجام دهد سپس پس از دست گذاری در اطراف مفصل زانو ساق پای آزمودنی را به ترتیب به چرخش داخلی، چرخش خارجی، گلاید داخلی ، گلاید خارجی، گلاید قدامی و گلاید خلفی خواهیم برد و همزمان از آزمودنی خواهیم خواست زانوی خود را به سمت همان جهت دردناک ببرد و اگر حرکت فعال آزمودنی که پیش از این دردناک بود با هر کدام از چرخش‌ها و یا گلایدها بدون درد انجام گرفت، از همان چرخش و یا گلاید برای ادامه‌ی درمان استفاده خواهیم کرد. این تکنیک باید بدون درد و یا با حداقل درد انجام گیرد و اگر درد کاهش پیدا کرد ولی به صفر نرسید، درمانگر با کم یا زیاد کردن فشار وارده و یا اعمال فشار اضافی در انتهای دامنه به حالت کاملا بدون درد خواهد رسید. این تکنیک در جلسه ی اول به صورت یک ست 6 تایی و در جلسات بعدی با توجه به توانایی آزمودنی به صورت 3 تا 5 ست 6 تا 10 ‌تایی انجام خواهد گرفت. برای انجام تکنیک در حالت ایستاده، آزمودنی کف پایی که زانوی آن دردناک است را روی یک چهارپایه به ارتفاع 30 سانتی متر(46) قرار خواهد داد؛ سپس حرکات خم و صاف کردن فعال زانو با اعمال چرخش‌های داخلی و خارجی و گلاید های داخلی و خارجی و گلاید های قدامی وخلفی به ساق آزمودنی را از آزمودنی خواهیم گرفت اگر آزمودنی در حین انجام خم و صاف کردن زانو، با هر کدام از گلایدها و چرخش‌ها درد نداشته باشد حرکت دردناک را با همان چرخش یا گلاید برای آزمودنی ادامه خواهیم داد.
    گروه مداخله: شرکت کنندگان در این گروه توسط درمانگر مسلط به تکنیک مولیگان و فیزیوتراپی معمول، ده جلسه درمان طی چهار هفته با حداقل یک روز فاصله بین جلسات دریافت خواهند کرد.درمان در هر گروه به مدت 60 دقیقه و شامل 3 فاز آماده‌سازی، تمرین درمانی و درمان‌های دستی خواهد بود. فاز اول، آماده سازی: در این مرحله آزمودنی‌ها تحریک الکتریکی سطحی عصب فرکانس بالا به مدت 20 دقیقه و مادون قرمز به مدت 15دقیقه دریافت خواهند کرد. 4 الکترود داخل پدهای مرطوب دور مفصل زانو ( دو الکترود در قسمت داخلی زانو در بالا و پایین خط مفصلی و دو الکترود در قسمت خارجی زانو در بالا و پایین خط مفصلی) قرار گرفته و توسط استرپ سفت خواهند شد. بسامد و طول موج مورد استفاده به ترتیب 110 هرتز و 50 میکروثانیه خواهد بود .فاز دوم، تمرین درمانی: تمرین درمانی در این افراد به صورت تمرینات تقویتی، تمرینات کششی و تمرینات دامنه حرکتی خواهند بود. تمرینات تقویتی شامل انقباض ایزوتونیک با کمک وزنه پا متغیر از عضلات صاف کننده زانو و دورکننده هیپ به ترتیب در حالت‌های نشسته لبه‌ی تخت و خوابیده به پهلو در حالی که زانوی دردناک بالا قرار گرفته باشد با فرکانس 3 جلسه در هفته با توجه به توانایی آزمودنی با شدت 60% تا 80% 1RM شامل 2 تا 4 ست 8 تا 15 تایی خواهند بود و بین هر ست 30 تا 60 ثانیه زمان استراحت به آزمودنی‌ها اختصاص خواهیم داد . برای کوتاهی عضلانی و یا کاهش دامنه‌ی حرکتی‌ای که عملکرد فرد را مختل می کند ، تمرینات کششی و تمرینات دامنه‌ی فعال بکار خواهیم برد. تمرینات کششی به مدت 30 ثانیه به تعداد 3 ست 10 تایی برای عضلات دوقلو ساق پا و عضله همسترینگ انجام خواهدگرفت و تمرینات دامنه‌ی حرکتی فعال و غیر فعال به صورت حرکت از حالت خم کامل زانو به حالت صاف کامل زانو به صورت 3 ست 10 تایی انجام خواهند گرفت. فاز سوم، درمان‌های دستی : در ابتدا این تمرینات را در حالت خوابیده به پشت با کمی خم بودن زانو انجام خواهیم داد .اگر آزمودنی در حالت خوابیده به پشت در خم یا صاف کردن زانو دردی نداشت این تکنیک را در حالت ایستاده برای آزمودنی انجام خواهیم داد. همچنین اگر بعد چند جلسه درمان در حالت خوابیده به پشت آزمونگر دیگر درد در خم و صاف کردن زانویش در این حالت نداشت تکنیک را در حالت ایستاده دنبال خواهیم کرد. روند درمان اینگونه خواهد بود که در حالت خوابیده به پشت با زانوی کمی خم از آزمودنی خواهیم خواست حرکات خم و صاف کردن زانو را به صورت فعال انجام دهد سپس پس از دست گذاری در اطراف مفصل زانو ساق پای آزمودنی را به ترتیب به چرخش داخلی، چرخش خارجی، گلاید داخلی ، گلاید خارجی، گلاید قدامی و گلاید خلفی خواهیم برد و همزمان از آزمودنی خواهیم خواست زانوی خود را به سمت همان جهت دردناک ببرد و اگر حرکت فعال آزمودنی که پیش از این دردناک بود با هر کدام از چرخش‌ها و یا گلایدها بدون درد انجام گرفت، از همان چرخش و یا گلاید برای ادامه‌ی درمان استفاده خواهیم کرد. این تکنیک باید بدون درد و یا با حداقل درد انجام گیرد و اگر درد کاهش پیدا کرد ولی به صفر نرسید، درمانگر با کم یا زیاد کردن فشار وارده و یا اعمال فشار اضافی در انتهای دامنه به حالت کاملا بدون درد خواهد رسید. این تکنیک در جلسه ی اول به صورت یک ست 6 تایی و در جلسات بعدی با توجه به توانایی آزمودنی به صورت 3 تا 5 ست 6 تا 10 ‌تایی انجام خواهد گرفت. برای انجام تکنیک در حالت ایستاده، آزمودنی کف پایی که زانوی آن دردناک است را روی یک چهارپایه به ارتفاع 30 سانتی متر(46) قرار خواهد داد؛ سپس حرکات خم و صاف کردن فعال زانو با اعمال چرخش‌های داخلی و خارجی و گلاید های داخلی و خارجی و گلاید های قدامی وخلفی به ساق آزمودنی را از آزمودنی خواهیم گرفت اگر آزمودنی در حین انجام خم و صاف کردن زانو، با هر کدام از گلایدها و چرخش‌ها درد نداشته باشد حرکت دردناک را با همان چرخش یا گلاید برای آزمودنی ادامه خواهیم داد. شرح مداخله ثانویه: پس از اتمام 10 جلسه مداخله فیزیوتراپی، شرکت‌کنندگان مجدداً به‌صورت تصادفی گروه‌بندی خواهند شد به‌گونه‌ای که از هر گروه تعداد مساوی در دو گروه مداخله و کنترل تخصیص یابد. در این مطالعه، مفصل زانوی با علائم شدیدتر برای ارزیابی فعال‌سازی عضلانی و فیت کردن بریس باربردارنده انتخاب خواهد شد. در صورت برابری شدت علائم در دو زانو، زانوی غالب انتخاب خواهد شد. هر دو گروه بریس را روزانه به مدت ۱ تا ۸ ساعت استفاده خواهند کرد و طی ۴ هفته، دوازده جلسه پیاده‌روی ۳۰ دقیقه‌ای را انجام خواهند داد. گروه کنترل از بریس بدون تحریک الکتریکی استفاده خواهد کرد، در حالی‌ که گروه NMES در حین راه رفتن از تحریک الکتریکی عصبی–عضلانی هم‌زمان با گیت بهره خواهد برد. شدت تحریک بر اساس بازخورد بیمار و تا بیشترین حد قابل تحمل تنظیم خواهد شد، به‌گونه‌ای که انقباضات بدون درد ایجاد شود و شرکت‌کنندگان به افزایش تدریجی شدت تشویق خواهند شد. آموزش نحوه قرارگیری الکترودها توسط فیزیوتراپیست انجام خواهد شد و پایبندی بیماران از طریق پیگیری‌های هفتگی و فرم‌های پایبندی پایش خواهد گردید.

Protocol summary

Study aim
General aim Investigating the effect of 10 treatment sessions of mulligan technique along with common physiotherapy in the knee joint on disability, pain and kinematic and spatiotemporal characteristics of walking and electromyographic activity of muscles during gait, sit to stand and static balance in people with knee osteoarthritis
Design
Clinical trial with treatment and control group, double-blind, stratified randomization on 38 patients by RANDOM NUMBER GENERATOR
Settings and conduct
First, the participants will be evaluated in the biomechanics laboratory, the subject and the examiner will be blind to the grouping and the examiner will not be present in the treatment process, then the examinees will receive 10 treatment sessions in the hospitals and clinics affiliated to the Iran University of Medical Sciences, then again will be evaluated in the laboratory.
Participants/Inclusion and exclusion criteria
- Age 40 to 70 years -Diagnosis of knee tibiofemoral joint arthrosis based on American College of Rheumatology criteria -Pain intensity (VAS) between 4 and 8 while walking at the time of evaluation - The severity of OA on K-L classification system, 2 and 3 - Ability to walk more than 6 meters -Pain of one-sided of the knee (even if a person has bilateral arthritis, a knee that is painful will be included in the study) - knee pain for more than 3 months
Intervention groups
In the treatment group, the participants will receive the common physiotherapy of knee arthrosis with the Mulligan technique, and in the control group they will receive the common physiotherapy of the knee arthrosis with the Mulligan technique in an artificial form. After 10 sessions of physiotherapy, the intervention group will receive electrical muscle stimulation along with walking for 12 sessions.
Main outcome variables
Disability, spatiotemporal and kinematic characteristics of walking and pain

General information

Reason for update
Completion and termination of sampling and addition of outcome and the second phase of the intervention, which was approved by the ethics committee.
Acronym
IRCT registration information
IRCT registration number: IRCT20190315043058N2
Registration date: 2024-01-09, 1402/10/19
Registration timing: prospective

Last update: 2025-12-31, 1404/10/10
Update count: 1
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Ismail Ebrahimi Takamjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 2426
Email address
ebrahimitakamjani.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-29, 1402/11/09
Expected recruitment end date
2024-08-30, 1403/06/09
Actual recruitment start date
2024-01-29, 1402/11/09
Actual recruitment end date
2024-10-30, 1403/08/09
Trial completion date
2024-12-29, 1403/10/09
Scientific title
The effects of Mobilization with movement technique and knee osteoarthritis conventional physiotherapy on disability, pain and spatiotemporal and kinematic characteristics of gait in individuals with knee osteoarthritis
Public title
The effects of Mobilization with movement technique and knee osteoarthritis conventional physiotherapy in knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age 40 to 70 years 2) Diagnosis of knee tibiofemoral joint arthrosis based on the criteria of the American College of Rheumatology (knee pain for at least the last 3 months, joint crepitation and morning stiffness lasting 30 minutes or less) by a specialist physician. 3) Pain intensity based on visual pain scale between 4 and 8 while walking at the time of evaluation 4) The severity of arthritis should be 2 and 3 based on the Kellgren and Lawrence classification system. 5) Ability to walk more than 6 meters 6) One-sided arthritis pain of the tibiofemoral joint of the knee (even if a person has bilateral arthritis, a knee that is painful will be included in the study) 7) Having knee pain for more than 3 months
Exclusion criteria:
1) Any neurological problem that affects a person's walking, such as a stroke 2) Arthritis secondary to trauma or accident or fracture in the joint 3) Any surgery and fracture in any of the lower limbs in the last year 4) Injection of corticosteroid or hyaluronic acid or platelet-rich plasma in the last 6 months 5) Any pain in the upper or lower joints 6) Heart problems with medium and high risk, such as uncontrolled angina or heart infarction in the last month 7) Inflammation and infection in the knee 8) Any prohibition to manual treatments such as severe osteoporosis or unstable joint 9) Cognitive problem 10) Receiving physiotherapy intervention for knee arthritis in the last 12 months 11) Body mass index above 35 12) Using walking aids 13) Smoking 14) Systemic diseases such as rheumatoid arthritis
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 38
Actual sample size reached: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided into two control and treatment groups by the stratified randomization method, so the two groups will be balanced in terms of gender, and the process of this random division will be such that after creating blocks of 4 in each class (male gender and female) which consist of letters A and B, we will create a random sequence of these blocks using RANDOM NUMBER GENERATOR and the subjects will be placed in two control and treatment groups based on the order of reference by this sequence. The individual generating the randomization sequence will not participate in any other phase of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the examiner or the person in charge of data collection and the one who evaluates the outcome and the subject or the participant will not know how the groups are divided. The examiner will not be present at the stage of dividing the subjects into treatment and control groups and the rest of the study stages. Also, the treatment that the subjects will receive in both groups will be apparently and look the same. In the treatment group, the subjects will receive preparatory treatments, therapeutic exercises and manual treatments in the form of the Mulligan technique, and in the control group, the subjects will receive preparatory treatments, therapeutic exercises and manual treatments in the form of the Mulligan technique in a simulated form; The method of performing this technique will be in such a way that no force will be applied to the place of handing after correct handing.
Placebo
Used
Assignment
Factorial
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, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1341853347
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.IUMS.REC.1402.665

2

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1341853347
Approval date
2023-10-29, 1402/08/07
Ethics committee reference number
IR.IUMS.REC.1402.668

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Disability score in Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
Timepoint
Measurement of Western Ontario and McMaster Universities Osteoarthritis Index questionnaire score at the beginning of the study and after 10 sessions of physiotherapy treatment
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index

Secondary outcomes

1

Description
Spatiotemporal and Kinematic characteristics of gait
Timepoint
Measurement of spatio-temporal and kinematic parameters of walking at the beginning of the study and after 10 sessions of physiotherapy treatment
Method of measurement
Vicon Motion Capture System

2

Description
Intensity of pain
Timepoint
Measurement of intensity of pain at the beginning of the study and after 10 sessions of physiotherapy treatment
Method of measurement
Visual Analogue Scale

3

Description
Characteristics of electromyographic activity of muscles during gait, sit to stand and static balance
Timepoint
Measurement of variables at the beginning of the study and after 10 sessions of physiotherapy treatment and after 12 sessions of home-based walking training.
Method of measurement
Kistler force plates and Myon electromyography system

Intervention groups

1

Description
Intervention group: Intervention group: The participants in this group will receive10 treatment sessions during 4 weeks with at least one day between sessions by a therapist who is proficient in the Mulligan technique and regular physical therapy. The treatment in each group lasts for 60 minutes and includes 3 phases of preparation, exercise therapy and manual treatments. The first phase, preparation: in this phase, subjects will receive high-frequency electrical nerve surface stimulation for 20 minutes and infra red for 15 minutes. 4 electrodes are placed inside wet pads around the knee joint (two electrodes on the medial of the knee above and below the joint line and two electrodes on the lateral of the knee above and below the joint line) and will be tightened by the strap. The frequency and pulse duration used will be 110 Hz and 50 microseconds, respectively. The second phase, exercise therapy: The exercise therapy for these people will be in the form of strengthening exercises, stretching exercises, and range of motion exercises. Strengthening exercises include isotonic contraction with the help of varying leg weights of the knee extensor and hip abductor muscles, respectively, in sitting positions on the edge of the bed and lying on the side while the painful knee is elevated, with a frequency of 3 sessions per week according to the ability of the subject with The intensity of 60% to 80% of 1RM will include 2 to 4 sets of 8 to 15 sets, and between each set we will allocate 30 to 60 seconds of rest time to the subjects. We will use stretching exercises and active range exercises for muscle shortening or reducing the range of motion that disrupts the person's performance. Stretching exercises will be performed for 30 seconds in 3 sets of 10 for the biceps and hamstring muscles, and active and passive range of motion exercises will be performed in the form of movement from fully bent knee to fully straightened knee in 3 sets of 10. will get The third phase, manual treatments: At first, we will perform these exercises while lying on the back with the knees slightly bent. If the subject does not have pain in bending or straightening the knee while lying on the back, we will perform this technique for the subject while standing. gave Also, if after a few treatment sessions, the examiner does not have pain in bending and straightening his knee while lying on his back, we will follow the technique while standing. The treatment process will be like this, lying on the back with a slightly bent knee, we will ask the subject to actively bend and straighten the knee, then after placing hands around the knee joint, the subject's leg will be internally rotated, respectively. We will perform external rotation, internal glide, external glide, anterior glide and posterior glide and at the same time we will ask the subject to move his knee in the same painful direction and if the active movement of the subject that was painful before with any of the rotations or glides It was done without pain, we will use the same rotation or glide to continue the treatment. This technique should be performed without pain or with minimal pain, and if the pain decreases but does not reach zero, the therapist will reach a completely pain-free state by increasing or decreasing the applied pressure or applying additional pressure at the end of the range. This technique will be performed in the first session as a set of 6 and in the following sessions, according to the subject's ability, as 3 to 5 sets of 6 to 10. To perform the technique in a standing position, the subject will place the sole of the foot whose knee is painful on a stool at a height of 30 cm ; Then we will take active knee bending and straightening movements by applying internal and external rotations, internal and external glides, and anterior and posterior glides to the subject's leg. If the rotations do not hurt, we will continue the painful movement with the same rotation or glide for the subject. Secondary intervention description: After completion 10 sessions of the physiotherapy intervention, participants will be re-randomized, such that an equal number of participants from each group will be allocated to the intervention and control groups. In this study, the knee joint with more severe symptoms will be selected for assessment of muscle activation and fitting of the unloader knee brace. In cases where symptom severity is equal in both knees, the dominant knee will be selected. Both groups will use the brace daily for 1 to 8 hours and will perform twelve 30-minute walking sessions over a four-week period. The control group will use the unloader knee brace without electrical stimulation, whereas the NMES group will receive neuromuscular electrical stimulation concurrently with gait during walking. Stimulation intensity will be adjusted based on patient feedback up to the maximum tolerable level, such that painless muscle contractions are elicited, and participants will be encouraged to gradually increase the stimulation intensity. Electrode placement will be instructed by a physiotherapist, and patient adherence will be monitored through weekly follow-ups and adherence forms.
Category
Treatment - Other

2

Description
Control group: Intervention group: Intervention group: The participants in this group will receive10 treatment sessions during 4 weeks with at least one day between sessions by a therapist who is proficient in the Mulligan technique and regular physical therapy. The treatment in each group lasts for 60 minutes and includes 3 phases of preparation, exercise therapy and artificial manual treatments . The first phase, preparation: in this phase, subjects will receive high-frequency electrical nerve surface stimulation for 20 minutes and infra red for 15 minutes. 4 electrodes are placed inside wet pads around the knee joint (two electrodes on the medial of the knee above and below the joint line and two electrodes on the lateral of the knee above and below the joint line) and will be tightened by the strap. The frequency and pulse duration used will be 110 Hz and 50 microseconds, respectively. The second phase, exercise therapy: The exercise therapy for these people will be in the form of strengthening exercises, stretching exercises, and range of motion exercises. Strengthening exercises include isotonic contraction with the help of varying leg weights of the knee extensor and hip abductor muscles, respectively, in sitting positions on the edge of the bed and lying on the side while the painful knee is elevated, with a frequency of 3 sessions per week according to the ability of the subject with The intensity of 60% to 80% of 1RM will include 2 to 4 sets of 8 to 15 sets, and between each set we will allocate 30 to 60 seconds of rest time to the subjects. We will use stretching exercises and active range exercises for muscle shortening or reducing the range of motion that disrupts the person's performance. Stretching exercises will be performed for 30 seconds in 3 sets of 10 for the biceps and hamstring muscles, and active and passive range of motion exercises will be performed in the form of movement from fully bent knee to fully straightened knee in 3 sets of 10.The third phase, manual treatments: after the usual physical therapy exercises, the Mulligan technique will be performed in an artificial way for these patients in such a way that hands will be placed around the joint and the subject will be asked to bend and straighten his knee without applying glide or pressure, and we will perform this operation in 3 to 5 sets of 6 to 10, and we will give the patient a 60-second rest between each set. All the mentioned steps, including the evaluation to find the glide or rotation with pain-free movement, as well as the part of performing the technique for the treatment, for the implementation of this technique in the treatment group, will be done exactly for the control group, and as it was said, the only difference will be this. It was that the glide or rotation in question will not be done in real way and no force will be applied and it will only be manual.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar general Hospital
Full name of responsible person
Hanieh Javan
Street address
Firoozgar Hospital, Beh Afarin St., Karim Khan Zand Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴87۱۱
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Reza falak
Street address
Office of Vice P Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hanieh Javan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Hanieh Javan.Unit 7, No 39, Alidoosti St, Ahaniamineh Ave, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653874986
Phone
+98 21 7788 9173
Email
javan.h@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Esmaeil Ebrahimi Takamjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
ebrahimitakamjani.e@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Esmaeil Ebrahimi Takamjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
ebrahimitakamjani.e@iums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
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