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Идёт набор NCT06944730

Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

Без фазы С лечением Chronic Low Back Pain (CLBP)

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: Structural Exercise, Isolated Trunk Exercise, Back school.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain (CLBP). Базовые параметры: 18 лет — 55 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Trunk and Lower Limb Movement Quality and Stability Improvement in People With Chronic Low Back Pain Following Different Types of Isometric Trunk Muscle Training

Обзор

The goal of this project is to assess if Chronic Low Back Pain (CLBP) participant's movement quality and balance variables can change after training that decreases their pain and disability. It will also compare the difference between structural exercise (SE) and isolated trunk exercise (ITE). The main questions it aims to answer are: 1. What are the effect of the training on the participant's movement quality and balance. 2. What are the difference between different types of trunk muscle training on people with CLBP. Researchers will compare SE, ITE and control. Control group will receive back school education that was shown not to be effective in reducing pain and disability. Participants will: 1. Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months. 2. Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.

Подробное описание

Both ITE and SE training are equalized in terms of training intensity based on rate of perceived exertion, training duration per session, training frequency, and intervention period. Training intensity measurement does not use other methods of quantification as ITE training does not increase heart rate or blood lactate significantly regardless of the intensity.

Вмешательства

  • Поведенческое Structural Exercise
    Multi-joint limb movement with force vector through the spine. The spine is held at neutral position
  • Поведенческое Isolated Trunk Exercise
    Holding the spine in neutral position with no limb movement, with static loading through the spine
  • Поведенческое Back school
    Patient education that has been proven to not be effective and has been used as control in past low back pain intervention studies

Первичные конечные точки

  • Lower lumbar active range of motion [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Segmental movement coordination [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Segmental movement stability [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Postural stability [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Postural Control [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Perceived pain [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Perceived disability [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • 5RSTS time [Срок оценки: Same day as first day of intervention and within one week after intervention]
Вторичные конечные точки (2)
  • LAP performance [Срок оценки: Same day as first day of intervention and within one week after intervention]
  • Muscle synergy [Срок оценки: Same day as first day of intervention and within one week after intervention]

Критерии участия

Критерии включения

  • body mass index (BMI) 18-25 kg/m2
  • experiencing intermittent pain lasting at least 3 months
  • had Oswestry Disability Index (ODI) score ranging between 17% and 45%.

Критерии исключения

  • exercise contraindication based on physical activity readiness questionnaire
  • indication or diagnosis of other chronic diseases (such as cancer, cardiovascular disease, diabetes, bone fracture, or infection)
  • artificial lower limb joints, history of spinal surgery, walking aid use
  • personal mobility restrictions (due to connective tissue diseases, rheumatoid arthritis, or central nervous system disorders)
  • pregnancy or within 1 year post partum

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Публикации

  • Sutanto D, Ho CY, Wong SHS, Pranata A, Yang Y. Difference in movement coordination and variability during Five-Repetition Sit-to-Stand between people with and without Chronic Low back pain. J Biomech. 2025 Mar;181:112531. doi: 10.1016/j.jbiomech.2025.112531. Epub 2025 Jan 19. PMID 39855104
  • Sutanto D, Yang YJ, Wong SH. A novel physical functioning test to complement subjective questionnaires in chronic low back pain assessments. Spine J. 2023 Apr;23(4):558-570. doi: 10.1016/j.spinee.2022.12.008. Epub 2022 Dec 17. PMID 36535534
  • Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001. PMID 1490034
  • Sutanto D, Ho RST, Poon ETC, Yang Y, Wong SHS. Effects of Different Trunk Training Methods for Chronic Low Back Pain: A Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 1;19(5):2863. doi: 10.3390/ijerph19052863. PMID 35270557
  • Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Terwee CB, Ostelo RW. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495. doi: 10.1097/j.pain.0000000000001117. PMID 29194127

Идентификаторы

NCT: NCT06944730 · HongKongPU RS · 2022.176

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗