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# Registration date Revision Id
2 2021-07-08, 1400/04/17 190884
1 2019-06-29, 1398/04/08 95063
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  • Protocol summary

    The effect of cervical treatment on pain, range of motion, and ultrasonic findings in patients with temporomandibular disorders
    The effects of routine treatment and manual therapy in patients with temporomandibular disorders
    بررسی تاثیر اصلاح ناحیه گردن بر روی میزان درد، دامنه حرکتی و یافته های سونوگرافی در بیماران با اختلالات فکی-گیجگاهی
    اثرات درمان روتین و منوال تراپی در بیماران با اختلالات فکی-گیجگاهی
    This study included two groups: control group and intervention group. study design: randomized control trial with control group, parallel group, non-blinded .
    This study included two groups: control group and intervention group. study design: randomized control trial with control group, parallel group. The patients and outcome assessor will be blind
    این مطالعه شامل دو گروه کنترل و گروه مداخله است. طراحی مطالعه: کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، کور سازی نشده ، تصادفی شده
    این مطالعه شامل دو گروه کنترل و گروه مداخله است. طراحی مطالعه: کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده. بیماران و ارزیابی کننده پیامد بلایند خواهند بود.
    Place of study: Iran University of Medical Sciences, School of rehabilitation, Ultrasonography laboratory Method: This study included two groups: control group and intervention group. Control group: The control group will receive the routine physiotherapy for six weeks. Intervention group: The intervention group will receive the routine physiotherapy AND treatment for cervical dysfunction for six weeks. two groups receive treatment two times per week during six weeks
    Place of study: Iran University of Medical Sciences, School of rehabilitation, Ultrasonography laboratory Method: This study included two groups: control group and intervention group. Control group: The control group will receive the routine physiotherapy including gentle massage over the masseter muscle, ultrasound 1 MHz and TENS. The intervention group will receive the routine physiotherapy AND manual therapy of temporomandibular joint and upper cervical .
    محل انجام مطالعه: آزمایشگاه اولتراسونوگرافی دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران نحوه انجام مطالعه: این مطالعه شامل دو گروه کنترل و گروه مداخله است. گروه کنترل:ا گروه کنترل درمان های رایج فیزیوتراپی را برای 6 هفته دریافت می کنند. گروه مداخله: افراد در گروه مداخله درمان های رایج فیزیوتراپی و درمان دیسفانکشن ناحیه گردن را بای 6 هفته دریافت می کنند. بیماران هر دو گروه درمان را دو بار در هفته، برای 6 هفته دریافت می کنند.
    محل انجام مطالعه: آزمایشگاه اولتراسونوگرافی دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران نحوه انجام مطالعه: این مطالعه شامل دو گروه کنترل و گروه مداخله است.هر دو گروه درمان های رایج فیزیوتراپی شامل اولتراسوند، ماساژ و TENS را دریافت می کنند و گروه مداخله علاوه بر اینها، منوال تراپی مفصل فکی-گیجگاهی و گردن راهم دریافت خواهند کرد.
    Inclusion criteria: 1-Individuals with age between 20-40 years 2-Individuals with tempromandibular disorders Exclusion criteria: 1-Individuals with disk herniation in cervical area 2-Individuals with neurology diseases as Parkinson, MS 3-Unwillingness to participate in the study
    Inclusion criteria: 1-unilateral or bilateral TMD according to the DC/TMD 2-pain more than 3 based on visual analog scale Exclusion criteria: 1-a traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months 2-history of the orofacial surgery during the last 6 months 3-neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
    شرایط ورود به مطالعه: 1-افراد بین سن 20-40 سال 2-افراد با اختلال در مفصل فکی-گیجگاهی شرایط خروج از مطالعه: 1-افراد با فتق دیسک در ناحیه گردن 2-افراد مبتلا به بیماری های نورولوژی شامل پارکینسون،MS 3-عدم تمایل افراد برای شرکت در مطالعه
    شرایط ورود به مطالعه: 1-TMD یک طرفه یا دو طرفه با توجه به DC / TMD 2-درد بیشتر از 3 بر حسب مقیاس بینایی درد شرایط خروج از مطالعه: 1-یک آسیب ضربه ای که باعث بروز علائم در مفصل گیجگاهی فکی و ناحیه دهان صورت در طی سه ماه گذشته شده است 2-سابقه جراحی دهان صورت در طی 6 ماه گذشته 3-بیماری های عصبی و سیستمیک مانند آرتریت روماتوئید. پارکینسون مولتیپل اسکلروزیس ، سرگیجه موضعی ، بارداری و تغییر شکل شدید در ناحیه فک یا صورت
    Control group: The control group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound 1MHZ and TENS (Acupuncture like) for six weeks. The patients in control group receive routine physiotherapy two times per week during six weeks. Intervention group: The intervention group will receive the routine physiotherapy AND treatment for cervical dysfunction for six weeks. The patients in intervention group receive routine physiotherapy AND treatment for cervical dysfunction two times per week during six weeks
    Control group: The control group will receive the routine physiotherapy such as massage, therapeutic ultrasound 1MHZ and TENS for eight weeks. Intervention group: The intervention group will receive the routine physiotherapy and manual therapy of TMJ and cervical spine. The patients in both groups will receive routine physiotherapy 10 sessions during eight weeks.
    گروه کنترل:افراد در گروه کنترل درمان های رایج فیزیوتراپی شامل: ماساژ، موبیلیزیشن مفصل فکی-گیجگاهی، اولتراسوند درمانی یک مگا هرتز و TENS(Acupuncture like) را برای 6 هفته دریافت می کنند. گروه کنترل درمان رایج فیریوتراپی را دو هفته برای 6 هفته دریافت می کنند. گروه مداخله: افراد در گروه مداخله درمان های رایج فیزیوتراپی و درمان دیسفانکشن ناحیه گردن را برای 6 هفته دریافت می کنند. بیماران گروه مداخله درمان را دو بار در هفته، برای 6 هفته دریافت می کنند.
    گروه کنترل:افراد در گروه کنترل درمان های رایج فیزیوتراپی شامل: ماساژ، موبیلیزیشن مفصل فکی-گیجگاهی، اولتراسوند درمانی یک مگا هرتز و TENS را برای 8 هفته دریافت می کنند. گروه مداخله: افراد در گروه مداخله درمان های رایج فیزیوتراپی و منوال تراپی مفصل فکی-گیجگاهی و گردن درمان دیسفانکشن ناحیه گردن را دریافت خواهند کرد. هر دو گروه درمان را ده جلسه در طول 8 هفته دریافت می کنند.
    pain; cervical range of motions, mouth opening; disk position
    pain; maximum mouth opening, cervical flexion and extension range of motions,
    درد، دامنه های حرکتی گردن، میزان باز شدن دهان، وضعیت دیسک
    درد، حداکثر دامنه باز شدن دهان، دامنه حرکتی فلکشن و اکستنشن گردن
  • General information

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    2019-07-23, 1398/05/01
    2019-11-01, 1398/08/10
    2020-02-20, 1398/12/01
    2021-02-01, 1399/11/13
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    Lack of time in coronary conditions
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    کمبود وقت در شرایط کرونا
    The effect of cervical treatment on function of people with temporomandibular pain
    The effects of routine treatment and manual therapy in people with temporomandibular disorder
    اثر اصلاح ناحیه گردن بر روی عملکرد بیماران با درد مفصل فکی-گیجگاهی
    اثرات درمان روتین و منوال تراپی در بیماران مبتلا به اختلال عملکرد گیجگاهی فکی
    The effect of cervical treatment on pain, range of motion, and ultrasonic findings in patients with temporomandibular disorders
    The effects of routine treatment and manual therapy on pain, and range of motion in patients with temporomandibular disorders
    بررسی تاثیر اصلاح ناحیه گردن بر روی میزان درد، دامنه حرکتی و یافته های سونوگرافی در بیماران با اختلالات فکی-گیجگاهی
    اثرات درمان روتین و منوال تراپی بر روی درد و دامنه حرکتی در بیماران مبتلا به اختلال عملکرد گیجگاهی فکی
    Individuals with age between 20-40 years
    Individuals with tempromandibular disorders
    Individuals with tunilateral or bilateral TMD according to the DC/TMD
    pain more than 3 based on visual analog scale
    افراد بین سن 20-40 سال
    افراد با اختلال در مفصل فکی-گیجگاهی
    افراد با اختلال یک طرفه و یا دو طرفه در مفصل فکی-گیجگاهی
    درد بیشتر از 3 بر حسب مقیاس بینایی درد
    Individuals with disk herniation in cervical area
    Individuals with neurology diseases as Parkinson, MS
    Unwillingness to participate in the study
    traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months
    history of the orofacial surgery during the last 6 months
    neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
    افراد با فتق دیسک در ناحیه گردن
    افراد مبتلا به بیماری های نورولوژی شامل پارکینسون، MS
    عدم تمایل افراد برای شرکت در مطالعه
    آسیب تروماتیک که باعث بروز علائم در مفصل گیجگاهی فکی و ناحیه دهان صورت در طی سه ماه گذشته شده است
    سابقه جراحی دهان صورت در طی 6 ماه گذشته
    بیماری های عصبی و سیستمیک مانند آرتریت روماتوئید. پارکینسون مولتیپل اسکلروزیس ، سرگیجه موضعی ، بارداری و تغییر شکل شدید در ناحیه فک یا صورت
    Randomization method: randomized block design, block size:4, ratio 1:1 Randomization tool: software
    Randomization method: Block balanced randomization design, block size:4, ratio 1:1 Randomization tool: Random allocation will be performed using the website of www.randomization.com.
    روش تصافی سازی: بلوک بندی تصادفی. اندازه بلوک 4 تایی و نسبت تخصیص 1:1 در نظر گرفته می شود. ابزار تصادفی سازی: نرم افزار
    روش تصافی سازی: بلوک بندی بالانس تصادفی. اندازه بلوک 4 تایی و نسبت تخصیص 1:1 در نظر گرفته می شود. ابزار تصادفی سازی: وب سایت www.randomization.com.
  • Primary outcomes

    #1
    Before the intervention(baseline), six weeks and three months later
    At the baseline, after the end of the treatment, and after a one-month follow-up period
    قبل از شروع مداخله, هفته شش و سه ماه بعد
    قبل از شروع مداخله, بعد از انتهای مداخله و یک ماه پس از پایان مداخله
    #2
    Cervical range of motion
    empty
    دامنه های حرکتی گردن
    empty
    Before the intervention(baseline) and six weeks and three months later
    empty
    قبل از شروع مداخله و هفته شش
    empty
    Goniometer
    empty
    گونیامتر
    empty
    #3
    Mouth opening
    empty
    دامنه باز شدن دهان
    empty
    Before the intervention(baseline), six weeks and three months later
    empty
    قبل از شروع مداخله, هفته شش و سه ماه بعد
    empty
    Ruler
    empty
    خط کش
    empty
    #4
    Lateral translation of mandible
    empty
    دامنه حرکت طرفی فک
    empty
    Before the intervention(baseline), six weeks and three months later
    empty
    قبل از شروع مداخله, هفته شش و سه ماه بعد
    empty
    Ruler
    empty
    خط کش
    empty
    #5
    Disk position
    empty
    وضعیت دیسک
    empty
    Before the intervention(baseline), six weeks and three months later
    empty
    قبل از شروع مداخله, هفته شش و سه ماه بعد
    empty
    Sonography
    empty
    سونوگرافی
    empty
  • Secondary outcomes

    #1
    empty
    Maximum mouth opening
    empty
    حداکثر دامنه باز شدن دهان
    empty
    At the baseline, after the end of the treatment, and after a one-month follow-up period
    empty
    قبل از شروع مداخله, بعد از انتهای مداخله و یک ماه پس از پایان مداخله
    empty
    caliper
    empty
    کالیپر استاندارد
    #2
    empty
    Cervical flexion and extension ROM
    empty
    دامنه حرکتی فلکشن و اکستنشن گردن
    empty
    At the baseline, after the end of the treatment, and after a one-month follow-up period
    empty
    قبل از شروع مداخله, بعد از انتهای مداخله و یک ماه پس از پایان مداخله
    empty
    Goniometer
    empty
    گونیامتر
  • Intervention groups

    #1
    Intervention group: The intervention group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound ultrasound 1MHZ and TENS (Acupuncture like) AND treatment for cervical dysfunction for six weeks. The patients in intervention group receive routine physiotherapy AND treatment for cervical dysfunction two times per week during six weeks
    Control group: The control group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS for ten sessions during 8 weeks.
    گروه مداخله: افراد در گروه مداخله درمان های رایج فیزیوتراپی شامل: ماساژ، موبیلیزیشن مفصل فکی -گیجگاهی و اولتراسوند درمانی یک مگا هرتز و TENS(Acupuncture like) و درمان دیسفانکشن ناحیه گردن را دریافت می کنند. بیماران گروه مداخله درمان را دو بار در هفته، برای 6 هفته دریافت می کنند.
    گروه کنترل: افراد در گروه کنترل درمان های رایج فیزیوتراپی شامل: ماساژ بر روی عضله ماستر، اولتراسوند درمانی یک مگا هرتز و TENS را برای ده جلسه در طول 8 هفته دریافت می کنند.
    #2
    Control group: The control group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound 1MHZ and TENS (Acupuncture like) for six weeks. The patients in control group receive routine physiotherapy two times per week during six weeks.
    Intervention group: The intervention group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS and manual therapy of the TMJ and upper cervical spine. This group will receive the interventions for ten sessions during 8 weeks.
    گروه کنترل: افراد در گروه کنترل درمان های رایج فیزیوتراپی شامل: ماساژ، موبیلیزیشن مفصل فکی-گیجگاهی و اولتراسوند درمانی یک مگا هرتز و TENS(Acupuncture like) را دریافت می کنند. گروه کنترل درمان رایج فیریوتراپی را دو بار در هفته، برای 6 هفته دریافت می کنند.
    گروه مداخله: افراد در گروه مداخله درمان های رایج فیزیوتراپی شامل: ماساژ بر روی عضله ماستر، اولتراسوند درمانی یک مگا هرتز و TENS و همچنین منوال تراپی مفصل فکی-گیجگاهی و ناحیه فوقانی گردن را برای ده جلسه در طول 8 هفته دریافت می کنند.
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rezaie Khaled
    Full name of responsible person - Persian: خالد رضایی
    Position - English: Phd student of Physiotherapy, Iran University of Medical Sciences
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی، دانشگاه علوم پزشکی ایران
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ ۱۵۴۵۹
    Phone: +98 21222280512
    Mobile: +98 912 479 9806
    Fax:
    Email: rezaie.kh@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rezaie Khaled
    Full name of responsible person - Persian: خالد رضایی
    Position - English: Phd student of Physiotherapy, Iran University of Medical Sciences
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی، دانشگاه علوم پزشکی ایران
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1348715459
    Phone: +98 21222280512
    Mobile: +98 912 479 9806
    Fax:
    Email: rezaie.kh@iums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amiri Ali
    Full name of responsible person - Persian: علی امیری
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، بلوار میرداماد، میدان مادر، خیابان شهید شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷۱۵۴۵۹
    Phone: +98 21 2222 7124
    Mobile: +98 912 394 9202
    Fax:
    Email: amiri.alipt10@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amiri Ali
    Full name of responsible person - Persian: علی امیری
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، بلوار میرداماد، میدان مادر، خیابان شهید شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1348715459
    Phone: +98 21 2222 7124
    Mobile: +98 912 394 9202
    Fax:
    Email: amiri.alipt10@yahoo.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rezaie Khaled
    Full name of responsible person - Persian: خالد رضایی
    Position - English: Phd student of Physiotherapy, Iran University of Medical Sciences
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی، دانشگاه علوم پزشکی ایران
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷۱۵۴۵۹
    Phone: +98 21222280512
    Mobile: +98 912 479 9806
    Fax:
    Email: rezaie.kh@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rezaie Khaled
    Full name of responsible person - Persian: خالد رضایی
    Position - English: Phd student of Physiotherapy, Iran University of Medical Sciences
    Position - Persian: دانشجوی دکتری تخصصی فیزیوتراپی، دانشگاه علوم پزشکی ایران
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1348715459
    Phone: +98 21222280512
    Mobile: +98 912 479 9806
    Fax:
    Email: rezaie.kh@iums.ac.ir
    Web page address:

Protocol summary

Study aim
The effects of routine treatment and manual therapy in patients with temporomandibular disorders
Design
This study included two groups: control group and intervention group. study design: randomized control trial with control group, parallel group. The patients and outcome assessor will be blind
Settings and conduct
Place of study: Iran University of Medical Sciences, School of rehabilitation, Ultrasonography laboratory Method: This study included two groups: control group and intervention group. Control group: The control group will receive the routine physiotherapy including gentle massage over the masseter muscle, ultrasound 1 MHz and TENS. The intervention group will receive the routine physiotherapy AND manual therapy of temporomandibular joint and upper cervical .
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-unilateral or bilateral TMD according to the DC/TMD 2-pain more than 3 based on visual analog scale Exclusion criteria: 1-a traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months 2-history of the orofacial surgery during the last 6 months 3-neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
Intervention groups
Control group: The control group will receive the routine physiotherapy such as massage, therapeutic ultrasound 1MHZ and TENS for eight weeks. Intervention group: The intervention group will receive the routine physiotherapy and manual therapy of TMJ and cervical spine. The patients in both groups will receive routine physiotherapy 10 sessions during eight weeks.
Main outcome variables
pain; maximum mouth opening, cervical flexion and extension range of motions,

General information

Reason for update
Lack of time in coronary conditions
Acronym
IRCT registration information
IRCT registration number: IRCT20190621043964N1
Registration date: 2019-06-29, 1398/04/08
Registration timing: prospective

Last update: 2021-07-19, 1400/04/28
Update count: 1
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Khaled Rezaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
rezaie.kh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2021-02-01, 1399/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of routine treatment and manual therapy on pain, and range of motion in patients with temporomandibular disorders
Public title
The effects of routine treatment and manual therapy in people with temporomandibular disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with tunilateral or bilateral TMD according to the DC/TMD pain more than 3 based on visual analog scale
Exclusion criteria:
traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months history of the orofacial surgery during the last 6 months neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block balanced randomization design, block size:4, ratio 1:1 Randomization tool: Random allocation will be performed using the website of www.randomization.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
Ir.Iums.Rec.1397.1054

Health conditions studied

1

Description of health condition studied
Temporomandibular dysfunction
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders

Primary outcomes

1

Description
pain
Timepoint
At the baseline, after the end of the treatment, and after a one-month follow-up period
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Maximum mouth opening
Timepoint
At the baseline, after the end of the treatment, and after a one-month follow-up period
Method of measurement
caliper

2

Description
Cervical flexion and extension ROM
Timepoint
At the baseline, after the end of the treatment, and after a one-month follow-up period
Method of measurement
Goniometer

Intervention groups

1

Description
Control group: The control group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS for ten sessions during 8 weeks.
Category
Rehabilitation

2

Description
Intervention group: The intervention group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS and manual therapy of the TMJ and upper cervical spine. This group will receive the interventions for ten sessions during 8 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Khaled Rezaie
Street address
Shariati Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
rezaie.kh@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Malakooti Seyyed Kazem
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@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
Rezaie Khaled
Position
Phd student of Physiotherapy, Iran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21222280512
Email
rezaie.kh@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amiri Ali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 7124
Email
amiri.alipt10@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rezaie Khaled
Position
Phd student of Physiotherapy, Iran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21222280512
Email
rezaie.kh@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The original data is shared in thesis format
When the data will become available and for how long
After defense of thesis, the original data is shared in thesis format.
To whom data/document is available
Academic researchers, physiotherapists
Under which criteria data/document could be used
In order to use clinical results, the original data is shared in thesis format.
From where data/document is obtainable
Library of the faculty of rehabilitation rehabilitation Sciences of Iran University of Medical Sciences
What processes are involved for a request to access data/document
Referral to library of the faculty of rehabilitation Sciences of Iran University of Medical Sciences
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