The design and construction of the modified lumbar pelvic belt and compares its effect on back and pelvic muscle activity and pain with the conventional pelvic belt in pregnant women
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Protocol summary
This study will be performed in Kosar specialized and sub-specialized clinic in Arak. Pelvic Girdle, DIO and pain intensity questionnaires will be used. The muscular activity of the lumbar and pelvic muscles will be evaluated during the ASLR ,trunk flexion-extension and standing with bare feet and walking in different positions using the belts. Blinding is one-sided
This study will be performed in Kosar specialized and sub-specialized clinic in Arak. Pelvic Girdle, SF36, DIO, and pain intensity questionnaires will be used. The muscular activity of the lumbar and pelvic muscles will be evaluated during the ASLR, trunk flexion extension, sitting-standing up, and walking in different positions using the belts. Blinding is one-sided
This study will be performed in Kosar specialized and sub-specialized clinic in Arak. Pelvic Girdle, SF36, DIO, and pain intensity questionnaires will be used. The muscular activity of the lumbar and pelvic muscles will be evaluated during the ASLR,trunk flexion extension, sitting-extension and standing with bare feetup, and walking in different positions using the belts. Blinding is one-sided
این مطالعه در کلینیک تخصصی و فوق تخصصی کوثر اراک انجام خواهد شد. در این مطالعه از پرسشنامه های Pelvic Girdle ، Disability Index Oswestry و ارزیابی شدت درد استفاده خواهد شد. همچنین فعالیت عضلانی عضلات کمر و لگن در حین انجام تست بالا آوردن فعال اندام تحتانی، فلکشن - اکستنشن تنه و در حالت ایستاده با پای برهنه و راه رفتن در حالات مختلف استفاده از کمربندها ارزیابی خواهد شد. کورسازی یک سویه است، تنها افراد شرکت کننده از تخصیص به گروه ها بی اطلاع هستند
این مطالعه در کلینیک تخصصی و فوق تخصصی کوثر اراک انجام خواهد شد. در این مطالعه از پرسشنامه های Pelvic Girdle ، Disability Index Oswestry، SFf36 و ارزیابی شدت درد استفاده خواهد شد. همچنین فعالیت عضلانی عضلات کمر و لگن در حین انجام تست بالا آوردن فعال اندام تحتانی، فلکشن - اکستنشن تنه، نشستن_ برخاستن و راه رفتن در حالات مختلف استفاده از کمربندها ارزیابی خواهد شد. کورسازی یک سویه است، تنها افراد شرکت کننده از تخصیص به گروه ها بی اطلاع هستند.
این مطالعه در کلینیک تخصصی و فوق تخصصی کوثر اراک انجام خواهد شد. در این مطالعه از پرسشنامه های Pelvic Girdle ، Disability Index Oswestry، SFf36 و ارزیابی شدت درد استفاده خواهد شد. همچنین فعالیت عضلانی عضلات کمر و لگن در حین انجام تست بالا آوردن فعال اندام تحتانی، فلکشن - اکستنشن تنه و در حالت ایستاده با پای برهنه، نشستن_ برخاستن و راه رفتن در حالات مختلف استفاده از کمربندها ارزیابی خواهد شد. کورسازی یک سویه است، تنها افراد شرکت کننده از تخصیص به گروه ها بی اطلاع هستند.
Lumbar or Pelvic pain; Lumbar muscle activity; Pelvic muscle activity; Function
Lumbar or Pelvic pain; Lumbar muscle activity; Pelvic muscle activity; Function; Quality of life
Lumbar or Pelvic pain; Lumbar muscle activity; Pelvic muscle activity; Function; Quality of life
درد کمری و یا لگنی؛ فعالیت عضلانی کمر؛ فعالیت عضلانی لگن؛ عملکرد
درد کمری و یا لگنی؛ فعالیت عضلانی کمر؛ فعالیت عضلانی لگن؛ عملکرد،کیفیت زندگی
درد کمری و یا لگنی؛ فعالیت عضلانی کمر؛ فعالیت عضلانی لگن؛ عملکرد،کیفیت زندگی
General information
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Add a new variable
Add a new variable
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افزودن یک متغیر جدید
افزودن یک متغیر جدید
Primary outcomes
#1
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Quality of life
Quality of life
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کیفیت زندگی
کیفیت زندگی
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At the beginning of the study and three weeks after using the belts
At the beginning of the study and three weeks after using the belts
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در ابتدای مطالعه و سه هفته پس از استفاده از کمربندها
در ابتدای مطالعه و سه هفته پس از استفاده از کمربندها
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SF36 Questionnaire
SF36 Questionnaire
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پرسشنامه SF36
پرسشنامه SF36
Intervention groups
#1
Intervention group 1: Common pregnancy pelvic belt with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity and disability and Disability Index Oswestry questionnaire to assess performance will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, standing with bare feet, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Pain Intensity Scale, Pelvic Girdle questionnaire and Disability Index Oswestry are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Intervention group 1: Common pregnancy pelvic belt with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, sitting and standing up, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Pain Intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Intervention group 1: Common pregnancy pelvic belt with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability and, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, sitting and standing with bare feetup, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Pain Intensity Scale, Pelvic Girdle questionnaire and, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
گروه مداخله اول: کمربند لگنی بارداری رایج به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی و پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنه- راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability Index Oswestry، تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
گروه مداخله اول: کمربند لگنی بارداری رایج به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها، ناتوانی و پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - نشستن و برخاستن- راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle، Disability Index Oswestryو SF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
گروه مداخله اول: کمربند لگنی بارداری رایج به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و، ناتوانی و پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنهنشستن و برخاستن- راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability، Disability Index Oswestry،Oswestryو SF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
#2
Intervention group 2: Pregnancy lumbar and pelvic belt made by the research team with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity and disability and Disability Index Oswestry questionnaire to assess performance will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, standing with bare feet, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Scale, Pelvic Girdle questionnaire and Disability Index Oswestry are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Intervention group 2: Pregnancy lumbar and pelvic belt made by the research team with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion, and extension, sitting and standing, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Intervention group 2: Pregnancy lumbar and pelvic belt made by the research team with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability and, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion, and extension, sitting and standing with bare feet, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Scale, Pelvic Girdle questionnaire and, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
گروه مداخله دوم: کمربند کمری لگنی بارداری ساخته شده توسط تیم تحقیق به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی و پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنه- راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability Index Oswestry، تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
گروه مداخله دوم: کمربند کمری لگنی بارداری ساخته شده توسط تیم تحقیق به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی، پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - نشستن و برخاستن - راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle ،Disability Index Oswestry وSF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
گروه مداخله دوم: کمربند کمری لگنی بارداری ساخته شده توسط تیم تحقیق به همراه مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی و، پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنهنشستن و برخاستن - راه رفتن انجام و ثبت می گردد. در نتیجه فعالیت عضلات قبل از بستن کمربند و پس از تجویز کمربند به صورت آنی ارزیابی می گردد. پس از سه هفته استفاده از کمربند ها به صورت روزانه 4 تا 5 ساعت و در حین فعالیت، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability،Disability Index Oswestry، وSF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن بدون استفاده و با استفاده از کمربند در تمام حالات قبل انجام و ثبت می گردد.
#3
Control group: Common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity and disability and Disability Index Oswestry questionnaire to assess performance will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyography device in the positions of - active straight leg raise test - trunk flexion and extension - standing with bare feet - walking. Then They are given common advice on preventing back and pelvic pain. After three weeks, they complete the Pain Intensity Scale, the Pelvic Girdle Questionnaire, and the Disability Index Oswestry. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded in all previous cases.
Control group: Common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyography device in the positions of - active straight leg raise test - trunk flexion and extension - sitting and standing - walking. Then They are given common advice on preventing back and pelvic pain. After three weeks, they complete the Pain Intensity Scale, the Pelvic Girdle Questionnaire, the Disability Index Oswestry, and SF36. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded in all previous cases.
Control group: Common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability and, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyography device in the positions of - active straight leg raise test - trunk flexion and extension - sitting and standing with bare feet - walking. Then They are given common advice on preventing back and pelvic pain. After three weeks, they complete the Pain Intensity Scale, the Pelvic Girdle Questionnaire, and the Disability Index Oswestry, and SF36. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded in all previous cases.
گروه کنترل: مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی و پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنه- راه رفتن انجام و ثبت می گردد. سپس مشاوره های رایج در پیشگیری از درد کمر و لگن به آنان داده می شود. پس از سه هفته، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability Index Oswestry، تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن در تمام حالات قبل انجام و ثبت می گردد.
گروه کنترل: مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی، پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - نشستن و برخاستن- راه رفتن انجام و ثبت می گردد. سپس مشاوره های رایج در پیشگیری از درد کمر و لگن به آنان داده می شود. پس از سه هفته، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle ،Disability Index Oswestry و SF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن در تمام حالات قبل انجام و ثبت می گردد.
گروه کنترل: مشاوره های رایج برای افراد، پرسشنامه های دموگرافیک، ارزیابی شدت درد(visual analogue scale )، پرسشنامه Pelvic Girdle به منظور ارزیابی درد، فعالیت ها و ناتوانی و، پرسشنامه Disability Index Oswestry به منظور ارزیابی عملکرد و پرسشنامه SF36 به منظور ارزیابی کیفیت زندگی تکمیل خواهد شد. همچنین فعالیت عضلانی کمر و لگن با استفاده از دستگاه الکترومیوگرافی سطحی در حالات - تست بالا آوردن فعال اندام تحتانی - فلکشن و اکستنشن تنه - ایستاده با پای برهنهنشستن و برخاستن- راه رفتن انجام و ثبت می گردد. سپس مشاوره های رایج در پیشگیری از درد کمر و لگن به آنان داده می شود. پس از سه هفته، مجددا برای آنان مقیاس ارزیابی شدت درد، پرسشنامه Pelvic Girdle وDisability،Disability Index Oswestry، و SF36 تکمیل می شود. همچنین فعالیت عضلانی عضلات کمر و لگن در تمام حالات قبل انجام و ثبت می گردد.
Recruitment centers
#1
Name of recruitment center - English: Kowsar specialized and sub-specialized clinic
Name of recruitment center - Persian: کلینیک تخصصی و فوق تخصصی کوثر
Full name of responsible person - English: Dr. Maryam Shekarpour
Full name of responsible person - Persian: خانم دکتر مریم شکر پور
Street address - English: Kowsar specialized and sub-specialized clinic, Emam Khomeyni street
Street address - Persian: خیابان امام خمینی، کلینیک تخصصی و فوق تخصصی کوثر
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3814113634
Phone: +98 86 3223 3823
Fax: +98 86 3223 6933
Email: it.kousar@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Kowsar specialized and sub-specialized clinic
Name of recruitment center - Persian: کلینیک تخصصی و فوق تخصصی کوثر
Full name of responsible person - English: Dr. Maryam Shokrpour
Full name of responsible person - Persian: خانم دکتر مریم شکر پور
Street address - English: Kowsar specialized and sub-specialized clinic, Emam Khomeyni street
Street address - Persian: خیابان امام خمینی، کلینیک تخصصی و فوق تخصصی کوثر
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3814113634
Phone: +98 86 3223 3823
Fax: +98 86 3223 6933
Email: it.kousar@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Kowsar specialized and sub-specialized clinic Name of recruitment center - Persian: کلینیک تخصصی و فوق تخصصی کوثر Full name of responsible person - English: Dr. Maryam ShekarpourShokrpour Full name of responsible person - Persian: خانم دکتر مریم شکر پور Street address - English: Kowsar specialized and sub-specialized clinic, Emam Khomeyni street Street address - Persian: خیابان امام خمینی، کلینیک تخصصی و فوق تخصصی کوثر City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3814113634 Phone: +98 86 3223 3823 Fax: +98 86 3223 6933 Email: it.kousar@arakmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamid Reza Khorram Khorshid
Full name of responsible person - Persian: دکتر حمید رضا خرم خورشید
Street address - English: University of Social Welfare and Rehabilitation Sciences, kodakyar Ave, daneshjoo Blvd, Evin, Tehran, Iran
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم بهزیستی و توانبخشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7173 2000
Fax:
Email: webmaster@uswr.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamid Reza Khorram Khorshid
Full name of responsible person - Persian: دکتر حمید رضا خرم خورشید
Street address - English: University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran Iran
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم بهزیستی و توانبخشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7173 2000
Fax:
Email: webmaster@uswr.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Hamid Reza Khorram Khorshid Full name of responsible person - Persian: دکتر حمید رضا خرم خورشید Street address - English: University of Social Welfare and Rehabilitation Sciences, kodakyarKoodakyar Ave, daneshjooDaneshjoo Blvd, Evin, Tehran, Iran Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم بهزیستی و توانبخشی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 7173 2000 Fax: Email: webmaster@uswr.ac.ir Web page address:
Protocol summary
Study aim
The design and construction of the modified lumbar pelvic belt and compares its effect on back and pelvic muscle activity and pain with the conventional pelvic belt in pregnant women
Design
According to clinical trial studies, participants in the study (48 people) were randomly divided into three groups. One group will be given a common pelvic girdle, the other group will be given a modified pelvic girdle belt made by the research team, to the third group none of the belts Will not be prescribed (control group).
Settings and conduct
This study will be performed in Kosar specialized and sub-specialized clinic in Arak. Pelvic Girdle, SF36, DIO, and pain intensity questionnaires will be used. The muscular activity of the lumbar and pelvic muscles will be evaluated during the ASLR, trunk flexion extension, sitting-standing up, and walking in different positions using the belts. Blinding is one-sided
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Pregnant women from the 20th week of pregnancy
Pregnant women with moderate to severe pain
Age under 40 years
Single pregnancy
Clinical diagnosis of low back pain or pelvic pain based on what people say
Criteria for non-entry include:
Pregnant women with a history of surgery on the spine or pelvis
Pregnant women with a history of back pain and pelvic pain before pregnancy
Systemic diseases
Any signs of high-risk pregnancy
Twin pregnancy
Depression
Neurological diseases
Common use of NSAIDs or any medication containing corticosteroids in the last 30 days
Intervention groups
The first intervention group will be given a common pelvic girdle, the second intervention group will be given a modified pelvic girdle made by the research team, and the control group will not be given any of the belts.
Main outcome variables
Lumbar or Pelvic pain; Lumbar muscle activity; Pelvic muscle activity; Function; Quality of life
General information
Reason for update
Add a new variable
Acronym
IRCT registration information
IRCT registration number:IRCT20200925048833N1
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2022-09-10, 1401/06/19
Update count:1
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Zhaleh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 3589
Email address
zh.heidari@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The design and construction of the modified lumbar pelvic belt and compares its effect on back and pelvic muscle activity and pain with the conventional pelvic belt in pregnant women
Public title
The effect of modified lumbar pelvic belt on back and pelvic muscle activity and pain in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women from the 20th week of pregnancy
Pregnant women with moderate to severe pain (Pain intensity 4 and above in VAS)
Age under 40 years
Single pregnancy
Clinical diagnosis of low back pain or pelvic pain based on the individual's own statement, negative answer to research questions and positive result of at least one of the following tests:1. Patrick's/Faber Test 2. posterior pelvic pain provocation 3.Modified Trendelenberg Test with direct palpation of the symphysis pubis 4.Active straight leg raise test
Exclusion criteria:
Pregnant women with a history of surgery on the spine or pelvis
Pregnant women with a history of back pain and pelvic pain before pregnancy
Systemic diseases such as restrictive lung diseases, heart disease and diabetes
Any signs of high-risk pregnancy
Twin pregnancy
Depression
Neurological diseases
Common use of NSAIDs or any medication containing corticosteroids in the last 30 days
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
According to clinical trial studies, participants in the study are randomly divided into three groups (first intervention, second intervention and control).The method of allocating samples in control and intervention groups is done in a simple randomization based on the lottery of sample members (individual randomization unit).In this method, using a table of random numbers, one of the numbers is touched and moved in one of the predetermined directions, each member of the sample whose number was selected, will be divided into one of the study groups, respectively. .
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 University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave, daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.USWR.REC.1399.161
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.05
ICD-10 code description
Panniculitis affecting regions of neck and back, thoracolumbar region
2
Description of health condition studied
Pelvic pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
lumbar or pelvic Pain
Timepoint
At the beginning of the study and three weeks after using the belts
Method of measurement
Visual Analogue Scale
2
Description
function
Timepoint
At the beginning of the study and three weeks after using the belts
Method of measurement
Pelvic Girdle Questionnaire, Disability Index Oswestry Questionnaire
3
Description
lumbar muscle activity
Timepoint
At the beginning of the study and three weeks after using the belts
Method of measurement
Surface Electromyography Device
4
Description
pelvic muscle activity
Timepoint
At the beginning of the study and three weeks after using the belts
Method of measurement
Surface Electromyography Device
5
Description
Quality of life
Timepoint
At the beginning of the study and three weeks after using the belts
Method of measurement
SF36 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Common pregnancy pelvic belt with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, sitting and standing up, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Pain Intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Category
Rehabilitation
2
Description
Intervention group 2: Pregnancy lumbar and pelvic belt made by the research team with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion, and extension, sitting and standing, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
Category
Rehabilitation
3
Description
Control group: Common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyography device in the positions of - active straight leg raise test - trunk flexion and extension - sitting and standing - walking. Then They are given common advice on preventing back and pelvic pain. After three weeks, they complete the Pain Intensity Scale, the Pelvic Girdle Questionnaire, the Disability Index Oswestry, and SF36. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded in all previous cases.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar specialized and sub-specialized clinic
Full name of responsible person
Dr. Maryam Shokrpour
Street address
Kowsar specialized and sub-specialized clinic, Emam Khomeyni street
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Fax
+98 86 3223 6933
Email
it.kousar@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamid Reza Khorram Khorshid
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zhaleh Heidari
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Orthosis and Prosthesis
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
webmaster@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zhaleh Heidari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Orthosis and Prosthesis
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
webmaster@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zhaleh Heidari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Others
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
webmaster@uswr.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the above will be published in the article.
When the data will become available and for how long
There will be access after the article is published.
To whom data/document is available
After the article is published, researchers can access it.
Under which criteria data/document could be used
Other researchers, obstetricians, therapists in the field of medicine and rehabilitation can use this research after the publication of the article.
From where data/document is obtainable
Refer to the published articles of this research.
What processes are involved for a request to access data/document