Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)
21 августа 2026 г. обновлено: Sena Çınarlı, Kocaeli Sağlık ve Teknoloji Üniversitesi
Ultrasonographic Characteristics of Accessory Inspiratory Muscles and Their Relationship With Respiratory Function in Individuals With Chronic Non-Specific Neck Pain: A Cross-Sectional Case-Control Study
This cross-sectional case-control study aims to investigate the ultrasonographic structural and functional characteristics of accessory inspiratory muscles in individuals with chronic non-specific neck pain and compare them with healthy controls.
In addition, the relationships between accessory inspiratory muscle characteristics, diaphragm function, respiratory muscle strength, and pulmonary function parameters will be examined.
The findings may improve understanding of the respiratory involvement associated with chronic neck pain and contribute to more comprehensive assessment strategies.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
- Диагностический тест: Diaphragm Ultrasonography
- Диагностический тест: Anterior Scalene Muscle Ultrasonography
- Диагностический тест: Upper Trapezius Muscle Ultrasonography
- Устройство: Maximal Inspiratory Pressure Measurement
- Устройство: Maximal Expiratory Pressure Measurement
- Устройство: Pulmonary Function Testing
Подробное описание
Chronic non-specific neck pain is a prevalent musculoskeletal disorder associated with pain, disability, and reduced quality of life. Emerging evidence suggests that its effects may extend beyond the cervical region and involve respiratory dysfunction. Previous studies have reported reductions in respiratory muscle strength, pulmonary function, and diaphragm function in individuals with chronic neck pain.
The diaphragm plays an important role not only in respiration but also in postural control and spinal stabilization. Ultrasonographic studies have demonstrated alterations in diaphragm thickness and mobility in individuals with chronic neck pain. However, little is known about potential compensatory adaptations occurring in accessory inspiratory muscles, including the sternocleidomastoid, anterior scalene, and upper trapezius muscles.
The purpose of this observational case-control study is to investigate the ultrasonographic characteristics of accessory inspiratory muscles in individuals with chronic non-specific neck pain and to compare these characteristics with those of healthy controls. Additionally, the relationships between accessory inspiratory muscle characteristics, diaphragm function, respiratory muscle strength, and pulmonary function will be examined.
Participants with chronic non-specific neck pain and age-matched healthy controls will undergo ultrasonographic assessment of the diaphragm and accessory inspiratory muscles, pulmonary function testing, and respiratory muscle strength evaluation. Associations among ultrasonographic, respiratory, and functional variables will be analyzed to improve understanding of respiratory involvement in chronic neck pain and to identify potential clinical assessment targets.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
10
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Hatice Sena Çınarlı, assisstant professor
- Номер телефона: 05436093619
- Электронная почта: haticesena.cinarli@kocaelisaglik.edu.tr
Места учебы
-
-
Derince
-
Kocaeli, Derince, Турция (Туркие), 41000
- Рекрутинг
- Derince Training and Research Hospital
-
Контакт:
- İlhan Celil Çınarlı, MD
- Номер телефона: 05436093619
- Электронная почта: haticesena.cinarli@kocaelisaglik.edu.tr
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Метод выборки
Невероятностная выборка
Исследуемая популяция
The study population will consist of adults aged 18 to 65 years.
The case group will include individuals with chronic non-specific neck pain lasting at least 3 months, while the control group will consist of age-matched healthy volunteers without neck pain during the previous 3 months.
Participants will be recruited from the Physical Medicine and Rehabilitation outpatient clinic and the surrounding community.
Описание
Inclusion Criteria
Chronic Non-Specific Neck Pain Group:
- Age between 18 and 65 years
- Presence of chronic non-specific neck pain for at least 3 months
- Non-traumatic origin of neck pain
- Pain intensity ≥ 3 on the Numeric Pain Rating Scale (NPRS) or Visual Analog Scale (VAS)
- Neck Disability Index (NDI) score ≥ 15
- Willingness to participate and provide informed consent
Healthy Control Group:
- Age between 18 and 65 years
- No neck pain during the previous 3 months
- Not receiving any treatment related to the cervical region
- Willingness to participate and provide informed consent
Exclusion Criteria (Both Groups):
- History of whiplash injury or cervical trauma
- Previous cervical spine surgery
- Cervical radiculopathy or neurological deficits
- Chronic respiratory diseases (e.g., COPD, asthma)
- Active respiratory tract infection
- Thoracic or abdominal surgery within the previous 6 months
- Rheumatologic, neuromuscular, or systemic inflammatory disorders
- Pregnancy
- Physiotherapy treatment for neck pain within the previous 3 months
- Regular respiratory muscle training or breathing exercises within the previous 3 months
- Inability to comply with study procedures or assessments
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
|
Diaphragm thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at the end of expiration and during maximal inspiration.
Anterior scalene muscle thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at rest and during maximal inspiratory effort.
Upper trapezius muscle thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at rest and during maximal inspiratory effort.
Maximal inspiratory pressure was measured using a respiratory pressure measurement device.
The participant performed a maximal inspiratory effort against an occluded airway after complete expiration.
Repeated measurements were performed with appropriate rest intervals.
Maximal expiratory pressure was measured using a respiratory pressure measurement device.
The participant performed a maximal expiratory effort against an occluded airway after maximal inspiration.
Repeated measurements were performed with appropriate rest intervals.
Pulmonary function testing was performed using spirometry while the participant was in a standardized seated position.
The participant completed maximal forced expiratory maneuvers following standardized instructions, and technically acceptable measurements were recorded.
|
|
Healthy Control
Age-matched healthy individuals without neck pain during the previous 3 months.
|
Diaphragm thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at the end of expiration and during maximal inspiration.
Anterior scalene muscle thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at rest and during maximal inspiratory effort.
Upper trapezius muscle thickness was assessed by ultrasonography while the participant was in a standardized position.
Measurements were obtained at rest and during maximal inspiratory effort.
Maximal inspiratory pressure was measured using a respiratory pressure measurement device.
The participant performed a maximal inspiratory effort against an occluded airway after complete expiration.
Repeated measurements were performed with appropriate rest intervals.
Maximal expiratory pressure was measured using a respiratory pressure measurement device.
The participant performed a maximal expiratory effort against an occluded airway after maximal inspiration.
Repeated measurements were performed with appropriate rest intervals.
Pulmonary function testing was performed using spirometry while the participant was in a standardized seated position.
The participant completed maximal forced expiratory maneuvers following standardized instructions, and technically acceptable measurements were recorded.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Diaphragm Thickening Ratio
Временное ограничение: Baseline
|
Diaphragm thickening ratio measured using ultrasonography.
|
Baseline
|
|
Sternocleidomastoid Muscle Thickness
Временное ограничение: Baseline
|
Sternocleidomastoid muscle thickness measured using ultrasonography.
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anterior Scalene Muscle Thickness
Временное ограничение: Baseline
|
Anterior scalene muscle thickness measured using ultrasonography.
|
Baseline
|
|
Upper Trapezius Muscle Thickness
Временное ограничение: Baseline
|
Upper trapezius muscle thickness measured using ultrasonography.
|
Baseline
|
|
Maximal Inspiratory Pressure (MIP)
Временное ограничение: Baseline
|
Maximal inspiratory pressure will be measured using a respiratory pressure measurement device.
Participants will perform a maximal inspiratory effort against an occluded airway after complete expiration.
The highest technically acceptable value will be recorded in cmH₂O.
Higher values indicate greater inspiratory muscle strength.
|
Baseline
|
|
Forced Vital Capacity (L)
Временное ограничение: Baseline
|
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
|
Maximal Expiratory Pressure (MEP)
Временное ограничение: Baseline
|
Maximal expiratory pressure will be measured using a respiratory pressure measurement device.
Participants will perform a maximal expiratory effort against an occluded airway after maximal inspiration.
The highest technically acceptable value will be recorded in cmH₂O.
Higher values indicate greater expiratory muscle strength.
|
Baseline
|
|
Forced Expiratory Volume in 1 Second (L)
Временное ограничение: Baseline
|
Forced expiratory volume in the first second will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
|
FEV1/FVC Ratio (%)
Временное ограничение: Baseline
|
The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.
|
Baseline
|
|
Peak Expiratory Flow (L/sn)
Временное ограничение: Baseline
|
Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
|
Forced Expiratory Flow at 25-75%
Временное ограничение: Baseline
|
Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
|
Baseline
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Colak GY, Ozyurek S, Sengul YS, Kalemci O. Differences of diaphragmatic muscle contraction between female patients with chronic neck pain and asymptomatic controls: A case-control study based on ultrasonography. Musculoskelet Sci Pract. 2024 Feb;69:102894. doi: 10.1016/j.msksp.2023.102894. Epub 2023 Dec 8.
- Hii EY, Kuo YL, Cheng KC, Hung CH, Tsai YJ. Ultrasonographic measurement indicated patients with chronic neck pain had reduced diaphragm thickness and mobility along with declined respiratory functions. Musculoskelet Sci Pract. 2024 Aug;72:102951. doi: 10.1016/j.msksp.2024.102951. Epub 2024 Apr 2.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
10 июня 2026 г.
Первичное завершение (Оцененный)
1 сентября 2026 г.
Завершение исследования (Оцененный)
1 декабря 2026 г.
Даты регистрации исследования
Первый отправленный
20 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
21 августа 2026 г.
Первый опубликованный (Действительный)
24 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 августа 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KOSTU-26-USG
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be made publicly available because the study involves sensitive health-related information and participant confidentiality cannot be fully guaranteed despite de-identification procedures.
Aggregate study findings will be reported in scientific publications.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .