- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07785427
Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Effect of Mechanically Loaded Neuro-dynamics on Physiological Findings and Functional Outcomes in Subjects With Thoracic Outlet Syndrome
the study was done to: To assess the effect of Mechanically Loaded Neuro-dynamics on pain reduction in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on shoulder range of motion in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on clinical provocative tests in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on neurophysiological findings in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on quality of life and psychological status in subjects with thoracic outlet syndrome.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Mohammed Abdulmohsen Almohamadi, physical therapist
- Номер телефона: 01050366830
- Электронная почта: ptmohammed1993@gmail.com
Места учебы
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Kafr ash Shaykh, Египет
- out-patient clinic, faculty of physical therapy - Kafrelsheikh University.
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Контакт:
- Mohammed Abdulmohsen Almohamadi, physical therapist
- Номер телефона: 01050366830
- Электронная почта: ptmohammed1993@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Subjects from both genders diagnosed with Thoracic Outlet Syndrome will be recruited through direct referrals from their neurosurgeon.
- Subjects age between 30.8±7.4 years
- Subjects body mass index = 19.5±2.8
- Control group includes health volunteer subjects with negative root test results under supervision of neurosurgeon.
Exclusion Criteria:
The exclusion criteria are:
- head injury, stroke.
- epilepsy episodes.
- mental disorders.
- cardiovascular disease.
- having a pacemaker or cochlear implant.
- pregnancy, oncological episodes, inflammatory disease, myelopathy, degenerative changes in the cervical spine (after verification on computed tomography or magnetic resonance imaging scans).
- peripheral neuropathies from the level of the arm and COVID-19-related symptoms
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: Mechanically Loaded Neuro-dynamics
involved 18 participants and received physical therapy management will include 11 visits over 11 weeks, Mechanically Loaded Neuro-dynamics was implemented using green medium-resistance bands (approximately 4.6-6.9
lbs. at 100% elongation).
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Physical therapy management will include 11 visits over 11 weeks, utilizing green medium-resistance bands (4.6-6.9 pounds at 100% elongation).
The protocol involves: weeks 3-4 with low tension isometric holds (5-10 seconds) in partial range; weeks 5-7 with dynamic repetitions (10-15 repetitions, 3 sets) in full range; and weeks 8-11 featuring sport-specific load progression with cycling postures and upper extremity tasks.
Repetitions will be slow and controlled, with cues to minimize guarding or Valsalva.
Progression will depend on symptom response and visual analogue scale scores, with Mechanically Loaded Neuro-dynamics performed 1-2 times weekly in-clinic and daily home exercises.
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Активный компаратор: traditional physical therapy program
involved 18 participants and received a traditional physical therapy program for Thoracic Outlet Syndrome (TOS)
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traditional physical therapy program
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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assessment of Active and passive Range of motion
Временное ограничение: At baseline and after 11 weeks
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Cervical spine range of motion (ROM) was assessed using a goniometer.
Participants were positioned comfortably in a standardized sitting position, with the trunk stabilized to minimize compensatory movements.
Cervical flexion, extension, lateral flexion, and rotation were measured in degrees.
The goniometer was aligned according to standard anatomical landmarks for each movement, and the active ROM was recorded at the end of the available pain-free range.
Measurements were performed consistently for all participants under the same testing conditions.
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At baseline and after 11 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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assessment of sensory nerve conduction velocity
Временное ограничение: At baseline and after 11 weeks
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For the digital sensory nerve conduction study, we will use standard antidromic techniques with a fixed distance of 11 cm between the recording and stimulating electrodes for the ulnar and 13 cm for the median sensory nerves.
Standard techniques and distances between recording and stimulating electrodes will be used for the medial antebrachial cutaneous (12 cm), lateral antebrachial cutaneous (12 cm), and the dorsal ulnar cutaneous (8 cm) nerve conduction study.
Sensory nerve conduction study parameters included sensory nerve action potential, amplitude and peak latency
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At baseline and after 11 weeks
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assessment of motor nerve conduction velocity
Временное ограничение: At baseline and after 11 weeks
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For motor nerve conduction study, also will be used a fixed distance of 7 cm between the recording and stimulating electrodes for both median and ulnar nerves.
motor nerve conduction study parameters included compound muscle action potential amplitude, area, distal latency, duration of the negative phase, and forearm conduction velocity.
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At baseline and after 11 weeks
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assessment of physical function and symptoms of the upper limb
Временное ограничение: At baseline and after 11 weeks
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The Disabilities of the Arm, Shoulder and Hand is a 30-item instrument assessing health status in daily activities, symptoms, social functioning, and psychological factors over the past week.
Responses range from 1 (no difficulty) to 5 (unable to perform), yielding scores from 0 to 100, where higher scores indicate greater disability.
The he Disabilities of the Arm, Shoulder and Hand demonstrates strong reliability, with an intraclass correlation coefficient of 0.74-0.95.
The minimum detectable change is 11 points, while the minimum clinically important difference is 10.83 points, indicating significant changes in patient function.
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At baseline and after 11 weeks
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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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Mohammed_Msc
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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