- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07826260
Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
Обзор исследования
Статус
Условия
Подробное описание
The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.
In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.
Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Žiga Kozinc, PhD
- Номер телефона: +386 040161503
- Электронная почта: ziga.kozinc@s2p.si
Места учебы
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Izola, Словения, 6310
- Рекрутинг
- University of Primorska, Faculty of Health Sciences, Izola
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Контакт:
- Žiga Kozinc, PhD
- Номер телефона: +386 040161503
- Электронная почта: ziga.kozinc@s2p.si
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Men and women aged 21 to 38 years.
- Resident of the Republic of Slovenia.
- No current low back pain.
- No contraindications to lumbar manual mobilization.
- Ability to assume and maintain the required prone testing position.
- Provision of written informed consent.
Exclusion Criteria:
- Current low back pain.
- Spondylolisthesis.
- Severe osteoporosis.
- Spinal stenosis.
- Lumboischialgia or other significant structural spinal deformity.
- Fibromyalgia.
- Recent spinal surgery or lumbar spinal fixation.
- Cauda equina syndrome.
- Nerve root compression associated with neurological deficits.
- Malignancy.
- Recent relevant trauma.
- Joint instability.
- Active rheumatoid arthritis.
- Acute local or systemic infection.
- Long-term local corticosteroid use.
- Inability to assume or maintain the required testing position.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Mobilization-Sham Sequence
Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
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Активный компаратор: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Erector Spinae Muscle Stiffness
Временное ограничение: Immediately before and immediately after each intervention session
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Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
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Immediately before and immediately after each intervention session
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Change in Multifidus Muscle Stiffness
Временное ограничение: Immediately before and immediately after each intervention session
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Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
|
Immediately before and immediately after each intervention session
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Временное ограничение: Immediately before and immediately after each intervention session
|
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the erector spinae shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
|
Immediately before and immediately after each intervention session
|
|
Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Временное ограничение: Immediately before and immediately after each intervention session
|
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the multifidus shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
|
Immediately before and immediately after each intervention session
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- UP-FHS-PA-SWE-2026
Планирование данных отдельных участников (IPD)
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Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .