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Набор скоро начнётся NCT07370272

CMCT Versus CSE in Treatment of SIJ Pain

Без фазы С лечением Sacroiliac Joint Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The conventional Physiotherpay Program (US & MET), Core Stability Exercises (CSE), Lumbopelvic cognitive movement control training (CMCT).
Кому может быть актуально
Состояния в реестре: Sacroiliac Joint Pain. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Lumbopelvic Cognitive Movement Control Training Versus Core Stability Exercises in Treatment of Sacroiliac Joint Pain

Обзор

This study aims to investigate the difference between integrating lumbopelvic cognitive movement control training versus core stabilization exercises to the conventional physiotherapy program on pain, function, lumbopelvic stability, functional load transfer, and postural control in patients suffering from SIJ pain. The main question it aims to answer is: What are the effects of adding lumbopelvic movement control training versus core stabilization exercises to the conventional physiotherapy program in treating patients with SIJ pain? Researchers will compare adding lumbopelvic movement control training versus core stabilization exercises to the conventional physiotherapy program to investigate its effectiveness in treatment of SIJ pain Participants will: 1. receive the intervention as follows: * Group (A) - Control Group: will receive conventional physiotherapy program (US and MET) * Group (B) - Core Stability Exercises Group: will receive conventional US, MET, and core stability ex's * Group (C) - Lumbopelvic cognitive movement control training Group: will receive conventional US, MET, and cognitive movement control training. 2. receive the training protocol 3 times a week for 8 weeks according to the set schedules. 3. perform a home exercise program in the same dose of repetitions and time as in the session. 4. be assessed before and after the intervention and training period to address the outcome measures.

Подробное описание

The sacroiliac joint (SIJ) pain is a significant contributor to LBP at any age, but it affects the elderly and young active people more frequently. Based on estimates from several studies, the SIJ causes pain in 10-38% of LBP patients. Altered lumbopelvic stability causes faulty movement of the spine during limb movement, and the faulty movement may cause mechanical irritation to the adjacent joint which when repeated and accumulated may cause LBP or SIJP. Additionally, it was revealed that patients with LBP have altered movement strategies in the form of uncontrolled movements which cause symptoms. This uncontrolled movement can be defined as 'an inability to cognitively control movement at a specific site and direction, while moving elsewhere to benchmark standards'.

Despite the need to identify the most effective treatment options for SIJ pain, controversy still remains with unclear definite conclusion regarding the use of physiotherapy interventions in those patients. Clinically, the diagnosis pathway has become more definite, but the treatment algorithm is less well-defined with conflicting evidence of the standard treatment either invasively or conservatively. For the management of SIJP, the conventional approach which includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region can be successfully used. Moreover, core stabilization exercises are considered a fundamental component of physiotherapy with the goal to improve the strength and coordination of deep core stabilizers such as the transversus abdominis, multifidus, and pelvic floor muscles, which are critical for maintaining lumbopelvic stability, reducing pain and disability and also, lowing the risk of recurrent injury. Among the conservative interventions, cognitive movement control training has begun to emerge as a promising management approach and garnered attention in recent years because it involves active cognitive participation and focuses on improving stability and neuromuscular control of the lumbosacral region.

Despite that stabilization and motor control exercises, in the context of the physiotherapy literature, are a well-established management method for LBP and SIJ region pain, there is still limited evidence on which stabilization or motor control training approach is more effective and leads to better outcomes in patients with LBP of sacroiliac origin. Unfortunately, within the available literature, various treatment plans for SIJ pain have been described but there are few published studies regarding postural lumbopelvic stability and SIJ and as a result, the assessment and management of SIJP subjects with potential balance or postural control deficits are valuable and needed.

Although the effectiveness of motor control training in reducing pain in the lumbar spine was confirmed, the need for the selection of exercises due to the occurrence of various forms of movement pattern disorders is still critical. This underlies the need to recognize individual differences in clinical presentation and/or which activities and functions are painful and difficult to do. Therefore, here is the importance of cognitive movement control training in targeting the patient's own complaint and also tailoring interventions based on assessment.

So, CMCT can be an effective form of treatment for lumbopelvic pain because this type of exercises restores normal muscle activation, proprioceptive reeducation, and retraining of movement patterns with a positive effect of on disability and pain severity in the short-term and long-term.

Despite it has been shown to have great clinical utility at the hip and groin and also, on the non-specific low back pain with positive effects on disability and pain severity in the short and long terms, there are no clear results about the effect of cognitive movement control retraining on patients with SIJP. Therefore, here is the significance of this study.

Вмешательства

  • Другое The conventional Physiotherpay Program (US & MET)
    The conventional approach includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region. The subjects will receive therapeutic ultrasound (for 5 mins, intensity of 1W/cm2). In addition, MET will be applied in prone for anterior and posterior innominate rotation around the pelvis. The subject will then be asked to apply 20% force against that applied by the therapist and hold that contraction for 10 seconds over 5 to 10 repetitions.
  • Другое Core Stability Exercises (CSE)
    In addition to the conventional protocol including US and MET stretching, subjects in this group will perform core stabilization exercises (CSE) to improve the activation and coordination of deep core stabilizers: transversus abdominis, multifidus, and pelvic floor muscles, which are essential for maintaining lumbopelvic stability and neuromuscular control. The core stabilization exercises consist of 5 exercises: pelvic tilt, double knee to chest, bridging, bird-dog, and cat-camel, to be perfor
  • Другое Lumbopelvic cognitive movement control training (CMCT)
    In addition to the traditional protocol including US and MET stretching, subjects in this group will undergo lumbopelvic cognitive movement control training (CMCT) that requires the lumbopelvic region to be positioned in a neutral alignment and the subject will be asked to consciously maintain the desired alignment and keep a pre-determined value of PBU whilst the lower limbs are actively moved to achieve a pre-determined benchmark. This training will be in multi-directions to address the lumbo

Первичные конечные точки

  • Pain: using Numerical Pain Rating Scale (NPRS) [Срок оценки: Baseline (pre-treatment) and after 8 weeks (post-treatment)]
  • Functional disability: using Oswestry Disability Index (ODI) [Срок оценки: Baseline (pre-treatment) and after 8 weeks (post-treatment)]
Вторичные конечные точки (3)
  • Lumbopelvic motor control function: by Pressure Biofeedback Unit (PBU) [Срок оценки: Baseline (pre-treatment) and after 8 weeks (post-treatment)]
  • Functional Load transfer: by Active straight leg raise test (ASLR) [Срок оценки: Baseline (pre-treatment) and after 8 weeks (post-treatment)]
  • Balance and Postural control: by Single leg stance balance test with eyes closed (SLSBT-EC) [Срок оценки: Baseline (pre-treatment) and after 8 weeks (post-treatment)]

Критерии участия

Критерии включения

  • Age of the subjects will range between 18 - 45 years for young middle-aged adults.
  • Unilateral SIJ pain lasting for at least 3 months, in lower back, buttock, groin, posterior superior iliac spine (PSIS) and with or without referral pain to the lower extremities.
  • SIJ pain below L5 region.
  • Non-centralized LBP i.e. has no directional preference.
  • Score positive on 3 out of 5 SIJP provocation tests: compression, distraction, sacral thrust, thigh thrust, Gaenslen's.

Критерии исключения

  • Limb-length discrepancy,
  • Clear signs of nerve root compression (radiating pain, motor and/or sensory deficits,
  • Previous major back surgery or injury, fracture or arthritis of spine, pelvis, hip, knee or ankle joint,
  • Seronegative spondyloarthropathies,
  • Visual or vestibular deficit,
  • Unable to follow command/ cognitive deficits,
  • Postpartum women less than six months,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of Physical Therapy, Cairo University — Giza

Публикации

  • Zaworski K, Gawlik K, Kregiel-Rosiak A, Baj-Korpak J. The effect of motor control training according to the Kinetic Control concept on the back pain of female football players. J Back Musculoskelet Rehabil. 2021;34(5):757-765. doi: 10.3233/BMR-200226. PMID 33896810
  • Yan H, Zhao P, Guo X, Zhou X. The effects of Core Stability Exercises and Mulligan's mobilization with movement techniques on sacroiliac joint dysfunction. Front Physiol. 2024 Apr 18;15:1337754. doi: 10.3389/fphys.2024.1337754. eCollection 2024. PMID 38699145
  • Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L, Willard FH. The sacroiliac joint: an overview of its anatomy, function and potential clinical implications. J Anat. 2012 Dec;221(6):537-67. doi: 10.1111/j.1469-7580.2012.01564.x. Epub 2012 Sep 19. PMID 22994881
  • Stochkendahl MJ, Kjaer P, Hartvigsen J, Kongsted A, Aaboe J, Andersen M, Andersen MO, Fournier G, Hojgaard B, Jensen MB, Jensen LD, Karbo T, Kirkeskov L, Melbye M, Morsel-Carlsen L, Nordsteen J, Palsson TS, Rasti Z, Silbye PF, Steiness MZ, Tarp S, Vaagholt M. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 20 PMID 28429142
  • Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30. PMID 31992024
  • Santos GK, Goncalves de Oliveira R, Campos de Oliveira L, Ferreira C de Oliveira C, Andraus RA, Ngomo S, Fusco A, Cortis C, DA Silva RA. Effectiveness of muscle energy technique in patients with nonspecific low back pain: a systematic review with meta-analysis. Eur J Phys Rehabil Med. 2022 Dec;58(6):827-837. doi: 10.23736/S1973-9087.22.07424-X. Epub 2022 Sep 28. PMID 36169931
  • Saner J, Kool J, Sieben JM, Luomajoki H, Bastiaenen CH, de Bie RA. A tailored exercise program versus general exercise for a subgroup of patients with low back pain and movement control impairment: A randomised controlled trial with one-year follow-up. Man Ther. 2015 Oct;20(5):672-9. doi: 10.1016/j.math.2015.02.005. Epub 2015 Feb 26. PMID 25770419
  • Saltychev M, Mattie R, McCormick Z, Barlund E, Laimi K. Psychometric properties of the Oswestry Disability Index. Int J Rehabil Res. 2017 Sep;40(3):202-208. doi: 10.1097/MRR.0000000000000226. PMID 28368870

Идентификаторы

NCT: NCT07370272 · CMCT in SIJ Pain

Первоисточники (государственные реестры)

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