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  • General information

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    Dear Editor The article protocol has been submitted for publication in a journal. At the request of the journal reviewer, some items in the exclusion criteria have been merged and more explanations have been added to some of the items of the inclusion criteria and sharing plans. Also, in the outcomes section, all outcomes were mistakenly listed as primary outcomes, which was corrected (outcomes have not changed, one outcome is considered as primary and the other outcomes are listed as secondary outcomes). Moreover, minor changes have been made to make the title more concise. For this reason, the protocol has been updated.
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    سلام و احترام پروتکل مقاله، برای چاپ در یک ژورنال، ارسال شده است. به درخواست داور مجله، برخی از موارد در معیارهای خروج ادغام شده و توضیحات بیشتری به برخی از موارد معیارهای ورود و طرح های اشتراک گذاری اضافه شده است. همچنین، در قسمت Outcome ها، به اشتباه، کلیه Outcome ها به عنوان پی آمد اولیه آمده بود، که اصلاح شد (Outcome ها تغییری نکرده اند، یک Outcome به عنوان اولیه، در نظر گرفته شده و سایر Outcome ها، به عنوانOutcome ثانویه، آمده اند). همچنین، تغییرات کوچکی، در جهت خلاصه تر کردن عنوان، انجام شده است. به همین دلیل، پروتکل، به روز رسانی شده است.
    Effect of motor control with forced respiratory training, in women with postpartum Lumbopelvic pain based on artificial intelligence algorithms
    Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain
    بررسی تاثیر تمرینات کنترل حرکت همراه با تمرینات تنفسی مقاومتی، در زنان مبتلا به درد کمری_لگنی پس از زایمان مبتنی بر الگوریتم های هوش مصنوعی
    بررسی تأثیر تمرینات کنترل حرکتی و تمرینات تنفسی بر درد، ناتوانی و فعالیت عضلات مرکزی زنان مبتلا به درد کمری پس از زایمان
    Effect of motor control with forced respiratory training, on pain, Disability, and core muscles activity in women with postpartum Lumbopelvic pain based on artificial intelligence algorithms
    Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain based on artificial intelligence algorithms
    بررسی تاثیر تمرینات کنترل حرکت همراه با تمرینات تنفسی مقاومتی، بر روی درد، ناتوانی و فعالیت عضلات مرکزی زنان مبتلا به درد کمری_لگنی پس از زایمان مبتنی بر الگوریتم های هوش مصنوعی
    بررسی تاثیر تمرینات کنترل حرکت همراه با تمرینات تنفسی، بر روی درد، ناتوانی و فعالیت عضلات مرکزی زنان مبتلا به درد کمری_لگنی پس از زایمان مبتنی بر الگوریتم های هوش مصنوعی
    Women with CNLBP: back pain without specific pathology that occurs between the last rib and the end of the gluteal fold.
    Women with pelvic pain: pain that occurs between the posterior iliac crest and the gluteal fold, especially around the sacroiliac joint, and at least three of the Posterior Pelvic Pain Provocation tests and the ASLR test are positive.
    Women who have back and pelvic pain together.
    The onset of lumbar, pelvic or lumbo-pelvic pain is during pregnancy or postpartum.
    At least 3 months and at most 1 year after postpartum.
    Age over 20 years
    The pain intensity of the patients, at the time of the test or during the last two weeks, should be between 3 and 7 on the visual analog scale.
    Reading and writing literacy (at least cycle level education)
    Vaginal delivery
    Body mass index below 30
    Women with CNLBP: back pain without specific pathology that occurs between the last rib and the end of the gluteal fold.
    Women with pelvic pain: Positive active straight leg raise (ASLR) test, and having a positive result on at least three of six sacroiliac provocation tests (including distraction, compression, posterior shear test (thigh-thrust test), Gaenslen provocation test (right), Gaenslen provocation test (left) and sacral thrust test).
    Women who have back and pelvic pain together.
    The onset of lumbar, pelvic or lumbopelvic pain is during pregnancy or postpartum.
    At least 3 months and at most 1 year after postpartum.
    Age over 20 years
    The pain intensity of the patients, at the time of the test or during the last two weeks, should be between 3 and 7 on the visual analog scale.
    Reading and writing literacy (at least cycle level education)
    Vaginal delivery
    Body mass index below 30
    زنان دارای کمردرد مزمن غیر اختصاصی: کمر دردی بدون پاتولوژی خاص که محل بروز آن بین دنده آخر و انتهای چین گلوتئال باشد
    زنان دارای درد لگنی : دردی که محل بروز آن، بین خلف کرست ایلیاک و چین گلوتئال، به خصوص حول مفصل ساکروایلیاک باشد وحداقل سه آزمون از آزمون های Posterior Pelvic Pain Provocation و تست ASLR آنها مثبت است
    زنانی که درد کمری و لگنی را با هم داشته باشند.
    شروع درد کمری، لگنی یا کمری_لگنی در زمان بارداری و یا پس از زایمان باشد.
    حداقل 3 ماه و حداکثر 1 سال از زایمان آن ها گذشته باشد.
    سن بالای 20 سال
    شدت درد بیماران، در زمان آزمون یا طی دو هفته گذشته، بین 3 تا 7 از مقیاس دیداری درد باشد.
    سواد خواندن و نوشتن (تحصیلات حداقل در حد سیکل).
    زایمان واژینال
    شاخص توده بدنی زیر 30
    زنان دارای کمردرد مزمن غیر اختصاصی: کمر دردی بدون پاتولوژی خاص که محل بروز آن بین دنده آخر و انتهای چین گلوتئال باشد
    زنان دارای درد لگنی : مثبت بودن آزمون ASLR و داشتن نتیجه مثبت در حداقل سه مورد از شش تست تحریک ساکروایلیاک (distraction, compression, posterior shear test (thigh-thrust test), Gaenslen provocation test (right), Gaenslen provocation test (left) and sacral thrust test).
    زنانی که درد کمری و لگنی را با هم داشته باشند.
    شروع درد کمری، لگنی یا کمری_لگنی در زمان بارداری و یا پس از زایمان باشد.
    حداقل 3 ماه و حداکثر 1 سال از زایمان آن ها گذشته باشد.
    سن بالای 20 سال
    شدت درد بیماران، در زمان آزمون یا طی دو هفته گذشته، بین 3 تا 7 از مقیاس دیداری درد باشد.
    سواد خواندن و نوشتن (تحصیلات حداقل در حد سیکل).
    زایمان واژینال
    شاخص توده بدنی زیر 30
    Any specific pathological cause (spinal canal stenosis, 3rd degree disc protrusion that causes radiculopathy, fractures, spinal tumors, etc.) by the doctor.
    History of neurological diseases, rheumatism.
    A history of any spinal dislocation in the lumbar region.
    Urinary incontinence based on the ICIQ-UI SF questionnaire.
    History of surgery in the back and pelvis.
    History of ankle surgery.
    History report of tumor in the pelvic area.
    Existence of obvious structural deformities in the spine such as kyphosis, scoliosis and spondylolisthesis and... .
    Movement limitation of knee and ankle joints in the ranges where the tests were performed.
    The presence of uterine prolapse and 3rd degree bladder prolapse, according to the doctor's diagnosis.
    Report of history of severe diabetes that required insulin injection during pregnancy.
    History report of cardiac, vascular and renal disorders.
    The number of deliveries more than 2 times.
    Reluctance to participate in the study.
    Spinal deformity or pathological condition (canal stenosis, scoliosis, spondylolisthesis, fractures, spinal or pelvic tumors…)
    History of neurological, cardiovascular, respiratory, renal diseases, or rheumatoid arthritis.
    Postpartum urinary dysfunctions
    History of surgical intervention in the lumbopelvic region.
    Urogenital prolapse above grade 3
    History of cesarean section or more than two vaginal deliveries
    Refusal to participate in the study.
    هر گونه علت پاتولوژیک مشخص(تنگی کانال نخاعی، بیرون زدگی درجه 3 دیسک که سبب رادیکولوپاتی، شکستگی، تومور های ستون فقرات و...) شده توسط پزشک.
    سابقه بیماری های نورولوژیکی، روماتیسمی.
    سابقه هر گونه سرخوردگی مهره در ناحیه کمری.
    بی‌اختیاری ادراری بر اساس پرسشنامه ICIQ-UI SF.
    سابقه جراحی در نواحی کمر و لگن.
    سابقه جراحی در ناحیه مچ پا.
    گزارش سابقه تومور در ناحیه لگنی.
    وجود دفورمیتی های آشکار ساختاری در ستون فقرات مثل کایفوز،اسکولیوزیس و اسپوندیلولیزتزیس و... .
    محدودیت حرکتی مفاصل زانو و مچ پا در دامنه هایی که آزمون ها اجرا شدند.
    وجود پرولاپس رحم و پرولاپس درجه 3 مثانه، طبق تشخیص پزشک.
    گزارش سابقه دیابت شدید که نیازمند تزریق انسولین در حین بارداری بوده اند.
    گزارش سابقه اختلالات قلبی، عروقی و کلیوی.
    تعداد زایمان بیش از 2 بار.
    عدم تمایل به شرکت در مطالعه.
    هر گونه تغییر شکل ستون فقرات یا علت پاتولوژیک (تنگی کانال نخاعی، اسکولیوز، اسپوندیلولیستزیس، شکستگی، تومور های ستون فقرات یا لگن و...)
    سابقه بیماری های نورولوژی، قلبی عروقی، تنفسی، کلیوی یا روماتیسمی.
    اختلالات ادراری پس از زایمان
    سابقه جراحی در ناحیه کمری لگنی.
    وجود پرولاپس اوروژنیتال درجه 3
    سابقه سزارین، یا تعداد زایمان طبیعی بیش از 2 بار.
    عدم تمایل به شرکت در مطالعه.
  • Health conditions studied

    #1
    Postpartum lumbo_pelvic pain
    Postpartum lumbopelvic pain
  • Primary outcomes

    #1
    Pain intensity: Pain intensity is a type of diagnostic information that, in order to check the patient's pain level, is measured by different criteria for measuring pain intensity, including the visual pain criterion.
    Excursion of the diaphragm muscle: The diaphragm muscle is the main respiratory muscle and is responsible for 75% of the air flow to the lungs. It plays a role in spinal stability, and its inappropriate function causes lumbopelvic pain. During the activity of the diaphragm muscle, the position of this muscle changes, and in people with back pain, this position change or displacement is less than in people without lumbopelvic pain.
    شدت درد: شدت درد نوعی از اطلاعات تشخیصی است که، به منظور بررسی میزان درد بیمار، توسط معیارهاي مختلف سنجش شدت درد، ازجمله معیار دیداري درد سنجیده می شود.
    جابه جایی عضله دیافراگم: عضله ي دیافراگم اصلی ترین عضله ي تنفسی است و مسئول 75 درصد جریان هوا به ریه است. در ثبات اسپاینال نقش دارد و عملکرد نامناسب آن باعث درد کمري-لگنی میشود در طی فعالیت عضله دیافراگم، پوزیشن این عضله تغییر می کند که در افراد مبتلا به کمردرد این تغییر پوزیشن یا جا به جایی کمتر از افراد بدون درد کمری_لگنی است.
    Pain intensity is measured at the beginning of the study (before therapeutic exercise) and 8 weeks later (after the final session of therapeutic exercise).
    Excursion of the diaphragm muscle is measured at the beginning of the study (before the exercise therapy) and 8 weeks later (after the final session of the exercise therapy).
    اندازه گیری شدت درد در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
    اندازه گیری جا به جایی عضله دیافراگم در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
    Pain intensity is measured using the visual analogue scale.
    The excursion of the right hemidiaphragm will be recorded during deep respiration and ASLR by ultrasound imaging.
    شدت درد با استفاده از سنجش معیار دیداری درد، اندازه گیری می شود.
    در این مطالعه جابجایی دیافراگم حین دم عمیق و ASLR، توسط اولتراسوند سطحی مورد بررسی قرار می گیرد.
    #2
    Disability: Disability refers to any condition in the body and mind that creates limitations for individuals to perform a series of activities and other things with people.
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    ناتوانی: ناتوانی، به هر گونه شرایطی در بدن و ذهن اطلاق می شود که، برای فرد محدودیت هایی را برای انجام یکسری فعالیت ها و تعامل با سایر افراد به وجود می آورد.
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    Disability is measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
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    اندازه گیری ناتوانی در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    In this study, the Persian version of the oswestry Disability scale Questionnaire, whose validity and reliability have been checked in Persian language, is used to examine the disability of women with lumbo-pelvic pain, on the other hand, this variable is quantified based on fuzzy logic.
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    در این مطالعه از نسخه فارسی پرسشنامه مقیاس ناتوانی اسوستری، که روایی و پایایی آن به زبان فارسی بررسی شده است، برای بررسی ناتوانی زنان دارای درد کمری_لگنی استفاده می شود، از طرفی بر پایه منطق فازی نیز، این متغیر کمی سازی می شود.
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    #3
    Pelvic floor muscle activity: the contraction of the pelvic floor muscles causes upward and inward forces in the pelvic floor and closes the urinary tract; which can play a role in creating stability in the lumbo-pelvic region.
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    فعالیت عضلات کف لگن: انقباض عضلات کف لگن سبب ایجاد نیروهایی به سمت بالا و داخل در کف لگن و بستن مجاری ادراری می شود؛ که می تواند در ایجاد ثبات در ناحیه کمری_لگنی ایفای نقش کند.
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    Pelvic floor muscle activity is measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
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    اندازه گیری فعالیت عضلات کف لگن در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    The displacement of the bladder base measured by ultrasound imaging is considered as the activity of the pelvic floor muscles.
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    میزان جابجایی قاعده مثانه که توسط تصویربرداری اولتراسوند اندازه گیری شده است، به عنوان فعالیت عضلات کف لگن در نظر گرفته می شود.
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    #4
    Transverse abdominal muscle activity: The transverse abdominus muscle plays a role in stabilizing the pelvic bone and the sacroiliac joint and theoretically causes a reduction in movement in this joint. The proper functioning of this muscle reduces the possibility of damage to the ligaments of the pelvic region, as a result of reducing the possibility of lumbo_pelvic pain.
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    فعالیت عضله عرضی شکم: عضله ترنسورس ابدومینوس در ایجاد ثبات در استخوان ناحیه لگن و مفصل ساکروایلیاک نقش دارد و به صورت تئوري سبب کاهش حرکت در این مفصل می شود. عملکرد مناسب این عضله، سبب کاهش احتمال آسیب به لیگامانهاي ناحیه لگنی، درنتیجه کاهش احتمال درد کمري- لگنی می شود.
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    Transverse abdominal muscle activity is measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
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    اندازه گیری فعالیت عضله عرضی شکم در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    In order to check the function of the transversus abdominis muscle, the change in the thickness of this muscle is checked by surface ultrasound.
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    به منظور بررسی عملکرد عضله عرضی شکم، تغییر ضخامت این عضله توسط اولتراسوند سطحی بررسی می گردد.
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    #5
    Activity of the internal and external oblique muscles: Activity of these muscles stabilizes the spine. These muscles create a brace around the abdomen.
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    فعالیت عضله مایل داخلی و خارجی: فعالیت این عضلات موجب ثبات ستون فقرات می شود. این عضلات باعث ایجاد brace در اطراف شکم، می شوند.
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    Measurement of internal and external oblique muscle activity is measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
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    اندازه گیری فعالیت عضلات مایل داخلی و خارجی در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    In order to check the function of these muscles, the change in the thickness of these muscles is checked by surface ultrasound.
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    به منظور بررسی عملکرد این عضلات، تغییر ضخامت این عضلات توسط اولتراسند سطحی بررسی می گردد.
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    #6
    Excursion of the diaphragm muscle: The diaphragm muscle is the main respiratory muscle and is responsible for 75% of the air flow to the lungs. It plays a role in spinal stability, and its inappropriate function causes lumbo-pelvic pain. During the activity of the diaphragm muscle, the position of this muscle changes, and in people with back pain, this position change or displacement is less than in people without lumbo_pelvic pain.
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    جابه جایی عضله دیافراگم: عضله ي دیافراگم اصلی ترین عضله ي تنفسی است و مسئول 75 درصد جریان هوا به ریه است. در ثبات اسپاینال نقش دارد و عملکرد نامناسب آن باعث درد کمري-لگنی میشود در طی فعالیت عضله دیافراگم، پوزیشن این عضله تغییر می کند که در افراد مبتلا به کمردرد این تغییر پوزیشن یا جا به جایی کمتر از افراد بدون درد کمری_لگنی است.
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    Excursion of the diaphragm muscle is measured at the beginning of the study (before the exercise therapy) and 8 weeks later (after the final session of the exercise therapy).
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    اندازه گیری جا به جایی عضله دیافراگم در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    In this study, excursion of the diaphragm at the end of the inhale is investigated by surface ultrasound.
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    در این مطالعه جابجایی دیافراگم در انتهای دم، توسط اولتراسوند سطحی مورد بررسی قرار می گیرد.
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  • Secondary outcomes

    #1
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    Pain intensity: Pain intensity is a type of diagnostic information that, in order to check the patient's pain level, will be measured by the visual pain criterion.
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    شدت درد: شدت درد نوعی از اطلاعات تشخیصی است که، به منظور بررسی میزان درد بیمار، توسط معیارهاي مختلف سنجش شدت درد، ازجمله معیار دیداري درد سنجیده می شود.
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    Pain intensity will be measured at the beginning of the study (before therapeutic exercise) and 8 weeks later (after the final session of therapeutic exercise)
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    اندازه گیری شدت درد در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
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    Pain intensity will be measured using the visual analog scale
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    شدت درد با استفاده از سنجش معیار دیداری درد، اندازه گیری خواهد شد.
    #2
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    Disability: Disability refers to any condition in the body and mind that creates limitations for individuals to perform a series of activities.
    empty
    ناتوانی: ناتوانی، به هر گونه شرایطی در بدن و ذهن اطلاق می شود که، برای فرد محدودیت هایی را برای انجام یکسری فعالیت ها و تعامل با سایر افراد به وجود می آورد.
    empty
    Disability will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
    empty
    اندازه گیری ناتوانی در ابتدای مطالعه ( قبل از تمرین درمانی) و 8 هفته بعد ( پس از جلسه پایانی تمرین درمانی) انجام خواهد شد.
    empty
    The Persian version of the ODI, which has demonstrated reliability and validity properties in individuals with low back pain, will be used.
    empty
    در این مطالعه از نسخه فارسی پرسشنامه مقیاس ناتوانی اسوستری، که روایی و پایایی آن به زبان فارسی بررسی شده است، برای بررسی ناتوانی استفاده خواهد شد.
    #3
    empty
    Pelvic floor muscle activity: the contraction of the pelvic floor muscles causes upward and inward forces in the pelvic floor and closes the urinary tract; which can play a role in creating stability in the lumbopelvic region.
    empty
    فعالیت عضلات کف لگن: انقباض عضلات کف لگن سبب ایجاد نیروهایی به سمت بالا و داخل در کف لگن و بستن مجاری ادراری می شود؛ که می تواند در ایجاد ثبات در ناحیه کمری_لگنی ایفای نقش کند.
    empty
    Pelvic floor muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
    empty
    اندازه گیری فعالیت عضلات کف لگن در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد از جلسه پایانی تمرین درمانی خواهد بود
    empty
    Ultrasound imaging will be used to assess pelvic floor muscle activity. The vertical distance of bladder base displacement, defined as the difference between the maximum displacement of the bladder base during deep expiration/ following a 10-second hold of the ASLR and the initial position of the bladder base at rest, will be regarded as an indicator of PFMs activity.
    empty
    برای ارزیابی فعالیت عضلات کف لگن، از تصویربرداری اولتراسوند استفاده خواهد شد.فاصله عمودی جابجایی قاعده مثانه، که به عنوان تفاوت بین حداکثر جابجایی قاعده مثانه در طول بازدم عمیق / پس از نگه داشتن 10 ثانیه ای ASLR و موقعیت اولیه قاعده مثانه در حالت استراحت تعریف می شود، به عنوان یک شاخص فعالیت عضلات کف لگن در نظر گرفته می شود.
    #4
    empty
    Abdominal muscle activity: Abdominal muscles play a role in stabilizing the spine, pelvic bone, and sacroiliac joint. These muscles create a brace around the abdomen
    empty
    فعالیت عضلات شکمی: فعالیت این عضلات موجب ثبات ستون فقرات، ناحیه لگن و مفصل ساکروایلیاک می شود. این عضلات باعث ایجاد brace در اطراف شکم، می شوند.
    empty
    Abdominal muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
    empty
    فعالیت عضلات شکمی در ابتدای مطالعه( قبل از تمرین درمانی) و 8 هفته بعد( پس از جلسه پایانی تمرین درمانی) اندازه گیری می شود.
    empty
    Using ultrasound imaging, the thickness of abdominal muscles will be measured at rest and then compared with the measurements obtained at the end of deep respiration and after a 10-second hold of the ASLR.
    empty
    با استفاده از تصویربرداری اولتراسوند، ضخامت عضلات شکم در حالت استراحت اندازه گیری می شود و سپس با اندازه گیری های به دست آمده در پایان تنفس عمیق و پس از 10 ثانیه نگه داشتن ASLR مقایسه می شود.
  • Intervention groups

    #1
    Intervention group: This group includes postpartum women with lumbo_pelvic pain who receive motor control exercises along with respiratory resistance training for 8 weeks and 3 times a week.
    Intervention group: This group includes postpartum women with lumbopelvic pain who receive motor control exercises along with respiratory resistance training for 8 weeks and 3 times a week.
    #2
    Control group: This group includes postpartum women with lumbo_pelvic pain who receive only motor control exercises for 8 weeks and 3 times a week.
    Control group: This group includes postpartum women with lumbopelvic pain who receive only motor control exercises for 8 weeks and 3 times a week.
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hosein Keivani
    Full name of responsible person - Persian: حسین کیوانی
    Street address - English: Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
    Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 2503
    Fax:
    Email: research-m@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Reza Falak
    Full name of responsible person - Persian: رضا فلک
    Street address - English: Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
    Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 2503
    Fax:
    Email: Falak.r@iums.ac.ir
    Web page address:
  • Sharing plan

    There is no further information.
    The final trial dataset will be available upon reasonable request from the corresponding author
    اطلاعات بیشتری وجود ندارد.
    اطلاعات مربوط به مطالعه، در صورت درخواست قانع کننده از نویسنده مسئول، در دسترس قرار خواهد گرفت
    Data related to the main outcomes are shared.
    Data, the full protocol, and statistical code are available upon reasonable request. All inquiries about data sharing should be directed to: shabnamshahali@yahoo.com
    داده هایی مرتبط با پیامد های اصلی به اشتراک گذاشته می شود.
    داده ها، پروتکل کامل و کد آماری در صورت درخواست قانع کننده، در دسترس خواهند بود. تمام سوالات مربوط به اشتراک گذاری داده ها باید به آدرس: shabnamshahali@yahoo.com ارسال شود
    Access starts 6 months after the results are published.
    After publishing the results, The final trial dataset will be available upon reasonable request from the corresponding author
    شروع دسترسی ۶ ماه پس از چاپ نتایج.
    بعد از چاپ نتایج، داده ها، در صورت درخواست قانع کننده از نویسنده مسئول، در دسترس قرار خواهد گرفت
    First, the person sends a message to the given email, after that the information is provided to the person by considering the job of the person who is working in the university and seeing the articles of the person who is identified as a researcher.
    Initially, the researcher or institution requesting access to the data should email the corresponding author. The corresponding author, after necessary checks, will provide the requested information.
    فرد ابتدا با ایمیل داده شده پیامی را ارسال می کند پس از آن با درنظر گرفتن شغل فرد که شاغل در دانشگاه است و دیدن مقالات فرد که به عنوان محقق شناسایی می شود اطلاعات در اختیار فرد قرار می گیرد.
    در ابتدا، محقق یا موسسه ای که درخواست دسترسی به داده ها را دارد باید به نویسنده مربوطه ایمیل بزند. نویسنده مسئول پس از بررسی های لازم، اطلاعات درخواستی را ارائه خواهد کرد.

Protocol summary

Study aim
Investigating the effect of motor control exercises with forced respiratory training on core muscles activity of women with postpartum lumbopelvic pain.
Design
RCT, single-blinded, with a factorial design on 48 participants. Randomization is done using the Randomization website.
Settings and conduct
Women are included in the study based on the inclusion and exclusion criteria. After that, ultrasound evaluations will be done. Treatments will be performed in the intervention and the control groups. Reassessment is done after the last treatment session. All assessments and exercises will be done in the laboratory of the Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Blinding: the examiner and the therapist are two people, and the examiner isn't aware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with a history of vaginal delivery in the past 3-12 months and suffering from CNLBP, and/ or pelvic pain or both back and pelvic pain. The onset of pain must be during pregnancy or after delivery, and the intensity of pain must be between 3 and 7 based on the VAS. Exclusion criteria: History of pathological, neurological, and RA diseases, lumbar spondylolisthesis, urinary incontinence, back, pelvic or ankle surgery, pelvic tumor, spine deformity, uterine and bladder prolapse, gestational diabetes, heart, vascular, kidney disorders and more than 2 deliveries.
Intervention groups
Participants will be assessed in two groups to investigate the additional effect of breathing exercises compared to motor control exercises alone, on the improvement of the study variables, participants will be assessed in two groups: Intervention group (respiratory resistance training + motor control exercises); Control group (motor control exercises)
Main outcome variables
Pain, disability, Core muscles activity

General information

Reason for update
Dear Editor The article protocol has been submitted for publication in a journal. At the request of the journal reviewer, some items in the exclusion criteria have been merged and more explanations have been added to some of the items of the inclusion criteria and sharing plans. Also, in the outcomes section, all outcomes were mistakenly listed as primary outcomes, which was corrected (outcomes have not changed, one outcome is considered as primary and the other outcomes are listed as secondary outcomes). Moreover, minor changes have been made to make the title more concise. For this reason, the protocol has been updated.
Acronym
Active straight leg raise(ASLR), Chronic non-specific low back pain (CNLB), Intraclass Correlation Coefficient (ICC), Minimal Detectable Changes (MDC), Oswestry Disability Index(ODI), International Consultation on Incontinence Question (ICIQ), Randomize
IRCT registration information
IRCT registration number: IRCT20180916041051N2
Registration date: 2024-05-21, 1403/03/01
Registration timing: registered_while_recruiting

Last update: 2025-02-06, 1403/11/18
Update count: 1
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Shabnam Shahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8769
Email address
shahali.sh@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain based on artificial intelligence algorithms
Public title
Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with CNLBP: back pain without specific pathology that occurs between the last rib and the end of the gluteal fold. Women with pelvic pain: Positive active straight leg raise (ASLR) test, and having a positive result on at least three of six sacroiliac provocation tests (including distraction, compression, posterior shear test (thigh-thrust test), Gaenslen provocation test (right), Gaenslen provocation test (left) and sacral thrust test). Women who have back and pelvic pain together. The onset of lumbar, pelvic or lumbopelvic pain is during pregnancy or postpartum. At least 3 months and at most 1 year after postpartum. Age over 20 years The pain intensity of the patients, at the time of the test or during the last two weeks, should be between 3 and 7 on the visual analog scale. Reading and writing literacy (at least cycle level education) Vaginal delivery Body mass index below 30
Exclusion criteria:
Spinal deformity or pathological condition (canal stenosis, scoliosis, spondylolisthesis, fractures, spinal or pelvic tumors…) History of neurological, cardiovascular, respiratory, renal diseases, or rheumatoid arthritis. Postpartum urinary dysfunctions History of surgical intervention in the lumbopelvic region. Urogenital prolapse above grade 3 History of cesarean section or more than two vaginal deliveries Refusal to participate in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the Randomization website. The people of both groups are identical in terms of demographic characteristics and are randomly divided into one of the two treatment groups with a ratio of 1:1. Randomization will be done by variable blocks method, which will consist of 4-letter blocks, made of letters A and B. The obtained treatment allocation is placed in sealed and numbered envelopes in the form of letters A and B. This process will be done by someone outside the research team and before the start of the study. After the initial evaluations by the examiner, the numbered envelopes are presented to him according to the sequential number of each person entered into the study, and the therapeutic intervention is adjusted based on the letters inside the envelope. The examiner is unaware of the letters inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner and the therapist are different people and the examiner is not aware of the way of grouping and the patients in each group, therefore the present study is a one-way blind study (blinding of the examiner).
Placebo
Not 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
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.IUMS.REC.1403.017

Health conditions studied

1

Description of health condition studied
Postpartum lumbopelvic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Excursion of the diaphragm muscle: The diaphragm muscle is the main respiratory muscle and is responsible for 75% of the air flow to the lungs. It plays a role in spinal stability, and its inappropriate function causes lumbopelvic pain. During the activity of the diaphragm muscle, the position of this muscle changes, and in people with back pain, this position change or displacement is less than in people without lumbopelvic pain.
Timepoint
Excursion of the diaphragm muscle is measured at the beginning of the study (before the exercise therapy) and 8 weeks later (after the final session of the exercise therapy).
Method of measurement
The excursion of the right hemidiaphragm will be recorded during deep respiration and ASLR by ultrasound imaging.

Secondary outcomes

1

Description
Pain intensity: Pain intensity is a type of diagnostic information that, in order to check the patient's pain level, will be measured by the visual pain criterion.
Timepoint
Pain intensity will be measured at the beginning of the study (before therapeutic exercise) and 8 weeks later (after the final session of therapeutic exercise)
Method of measurement
Pain intensity will be measured using the visual analog scale

2

Description
Disability: Disability refers to any condition in the body and mind that creates limitations for individuals to perform a series of activities.
Timepoint
Disability will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
The Persian version of the ODI, which has demonstrated reliability and validity properties in individuals with low back pain, will be used.

3

Description
Pelvic floor muscle activity: the contraction of the pelvic floor muscles causes upward and inward forces in the pelvic floor and closes the urinary tract; which can play a role in creating stability in the lumbopelvic region.
Timepoint
Pelvic floor muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
Ultrasound imaging will be used to assess pelvic floor muscle activity. The vertical distance of bladder base displacement, defined as the difference between the maximum displacement of the bladder base during deep expiration/ following a 10-second hold of the ASLR and the initial position of the bladder base at rest, will be regarded as an indicator of PFMs activity.

4

Description
Abdominal muscle activity: Abdominal muscles play a role in stabilizing the spine, pelvic bone, and sacroiliac joint. These muscles create a brace around the abdomen
Timepoint
Abdominal muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
Using ultrasound imaging, the thickness of abdominal muscles will be measured at rest and then compared with the measurements obtained at the end of deep respiration and after a 10-second hold of the ASLR.

Intervention groups

1

Description
Intervention group: This group includes postpartum women with lumbopelvic pain who receive motor control exercises along with respiratory resistance training for 8 weeks and 3 times a week.
Category
Rehabilitation

2

Description
Control group: This group includes postpartum women with lumbopelvic pain who receive only motor control exercises for 8 weeks and 3 times a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Shabnam ShahAli
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, 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
1431793163
Phone
+98 912 074 9932
Email
shabnamshahali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Falak.r@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
Shabnam Shahali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Dadgoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
dadgoo.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabnam Shahali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The final trial dataset will be available upon reasonable request from the corresponding author
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
Data, the full protocol, and statistical code are available upon reasonable request. All inquiries about data sharing should be directed to: shabnamshahali@yahoo.com
When the data will become available and for how long
After publishing the results, The final trial dataset will be available upon reasonable request from the corresponding author
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
Use of the data can be done for further research work in the future.
From where data/document is obtainable
Iran University of Medical Sciences, Faculty of Rehabilitation, Madadkaran St., Madar Square, Tehran. Postal code: 1545913487. shabnamshahali@yahoo.com.
What processes are involved for a request to access data/document
Initially, the researcher or institution requesting access to the data should email the corresponding author. The corresponding author, after necessary checks, will provide the requested information.
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