- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Lumbar instability is a common medical problem. There is a 50-70% chance of a person suffering from LBP during his or her lifetime having lumbar instability. It is often referred to as clinical spinal instability. Clinical spinal instability is controversial and poorly understood. Properly conducted clinical studies of patients with spinal pain and documented clinical instability would be good to explore this concept. However, pursuing such a course is difficult.
The diaphragm has a dual role in respiration and postural control. Evidence suggests that current core stability exercises for low back pain are superior to minimal or no treatment, however, no more beneficial than general exercises and/or manual therapy. There appears to be a higher focus on the transverses abdominis and multifidi muscles and minimal attention to the diaphragm.
We propose that any form of core stabilization exercises for low back pain rehabilitation should consider the diaphragm. Core stabilization program could commence with facilitation of normal breathing patterns and progressive systematic restoration of the postural control role of the diaphragm muscle.
So, the aim of this trial is to determine whether combining diaphragmatic strengthening exercises with core stability training leads to faster improvements in pain and instability in individuals with lumbar instability, compared to traditional core exercises alone.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ahmed Hesham Abd El-Mawgoud, B.Sc
- Номер телефона: +20 11 20484750
- Электронная почта: ahmed.hesham.hassona@gmail.com
Учебное резервное копирование контактов
- Имя: Mona AbdelRaouf Moursy, PhD
Места учебы
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Cairo, Египет
- Outpatient clinic of the faculty of physical therapy, Cairo University
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Контакт:
- Ahmed Hesham Abd El-Mawgoud, B.Sc
- Номер телефона: +20 11 20484750
- Электронная почта: ahmed.hesham.hassona@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age between 25 and 35 years.
- Positive prone instability test.
- Straight leg raising >90 degrees.
- Pain assessment on VAS >5/10.
- All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)
Exclusion Criteria:
- Patients with cardiovascular diseases.
- Patients with cerebrovascular diseases.
- Patients with neurological diseases.
- Patients with any attention disorders or physical disability.
- Patients with any diseases/conditions preventing physical activity participation.
- Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
- Patients with central obesity (A waist to hip ratio >0.90 in males or > 0.85 in females).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Combined diaphragm strengthening + Core stability exercises
It will include patients that will perform combined diaphragm strengthening and core stability exercises.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session).
Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).
Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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Активный компаратор: Core stability exercises
It will include patients that will perform core stability exercises alone.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain intensity assessed using the Visual Analogue Scale (VAS)
Временное ограничение: 8 weeks
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Pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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8 weeks
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Pressure pain threshold assessed by pressure algometry
Временное ограничение: 8 weeks
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Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer.
Higher values indicate reduced pain sensitivity.
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8 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
Временное ограничение: 8 weeks
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Core muscle stability will be assessed using a Pressure Biofeedback Unit during abdominal drawing-in tasks.
Improved pressure control indicates better activation of the local stabilizing muscles.
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8 weeks
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Functional disability assessed using the Oswestry Disability Index (ODI)
Временное ограничение: 8 weeks
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Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
Scores range from 0 to 100%, with higher scores indicating greater disability.
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8 weeks
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Ahmad Mahdi Ahmad, PhD, Professor, Cairo University
- Директор по исследованиям: Maged Mohamed Samy Abouelsoud, PhD, Professor, Ain Shams University
- Директор по исследованиям: Mona AbdelRaouf Moursy, Assist. Professor, Cairo University
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
- P.T.REC/012/006064
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.
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