Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)
21 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
- Prueba de diagnóstico: Diaphragm Ultrasonography
- Prueba de diagnóstico: Anterior Scalene Muscle Ultrasonography
- Prueba de diagnóstico: Upper Trapezius Muscle Ultrasonography
- Dispositivo: Maximal Inspiratory Pressure Measurement
- Dispositivo: Maximal Expiratory Pressure Measurement
- Dispositivo: Pulmonary Function Testing
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
10
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hatice Sena Çınarlı, assisstant professor
- Número de teléfono: 05436093619
- Correo electrónico: haticesena.cinarli@kocaelisaglik.edu.tr
Ubicaciones de estudio
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-
Derince
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Kocaeli, Derince, Turquía (Türkiye), 41000
- Reclutamiento
- Derince Training and Research Hospital
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Contacto:
- İlhan Celil Çınarlı, MD
- Número de teléfono: 05436093619
- Correo electrónico: haticesena.cinarli@kocaelisaglik.edu.tr
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diaphragm Thickening Ratio
Periodo de tiempo: Baseline
|
Diaphragm thickening ratio measured using ultrasonography.
|
Baseline
|
|
Sternocleidomastoid Muscle Thickness
Periodo de tiempo: Baseline
|
Sternocleidomastoid muscle thickness measured using ultrasonography.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anterior Scalene Muscle Thickness
Periodo de tiempo: Baseline
|
Anterior scalene muscle thickness measured using ultrasonography.
|
Baseline
|
|
Upper Trapezius Muscle Thickness
Periodo de tiempo: Baseline
|
Upper trapezius muscle thickness measured using ultrasonography.
|
Baseline
|
|
Maximal Inspiratory Pressure (MIP)
Periodo de tiempo: 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
|
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Forced Vital Capacity (L)
Periodo de tiempo: Baseline
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Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
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Maximal Expiratory Pressure (MEP)
Periodo de tiempo: 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
|
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Forced Expiratory Volume in 1 Second (L)
Periodo de tiempo: Baseline
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Forced expiratory volume in the first second will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
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Baseline
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FEV1/FVC Ratio (%)
Periodo de tiempo: Baseline
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The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.
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Baseline
|
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Peak Expiratory Flow (L/sn)
Periodo de tiempo: Baseline
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Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
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Baseline
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Forced Expiratory Flow at 25-75%
Periodo de tiempo: Baseline
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Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
|
Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de junio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KOSTU-26-USG
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .