Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)
21 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
- Teste de diagnostico: Diaphragm Ultrasonography
- Teste de diagnostico: Anterior Scalene Muscle Ultrasonography
- Teste de diagnostico: Upper Trapezius Muscle Ultrasonography
- Dispositivo: Maximal Inspiratory Pressure Measurement
- Dispositivo: Maximal Expiratory Pressure Measurement
- Dispositivo: Pulmonary Function Testing
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
10
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hatice Sena Çınarlı, assisstant professor
- Número de telefone: 05436093619
- E-mail: haticesena.cinarli@kocaelisaglik.edu.tr
Locais de estudo
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-
Derince
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Kocaeli, Derince, Turquia (Türkiye), 41000
- Recrutamento
- Derince Training and Research Hospital
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Contato:
- İlhan Celil Çınarlı, MD
- Número de telefone: 05436093619
- E-mail: haticesena.cinarli@kocaelisaglik.edu.tr
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diaphragm Thickening Ratio
Prazo: Baseline
|
Diaphragm thickening ratio measured using ultrasonography.
|
Baseline
|
|
Sternocleidomastoid Muscle Thickness
Prazo: Baseline
|
Sternocleidomastoid muscle thickness measured using ultrasonography.
|
Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anterior Scalene Muscle Thickness
Prazo: Baseline
|
Anterior scalene muscle thickness measured using ultrasonography.
|
Baseline
|
|
Upper Trapezius Muscle Thickness
Prazo: Baseline
|
Upper trapezius muscle thickness measured using ultrasonography.
|
Baseline
|
|
Maximal Inspiratory Pressure (MIP)
Prazo: 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)
Prazo: Baseline
|
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
|
Maximal Expiratory Pressure (MEP)
Prazo: 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)
Prazo: 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.
|
Baseline
|
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FEV1/FVC Ratio (%)
Prazo: 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)
Prazo: Baseline
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Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
|
Baseline
|
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Forced Expiratory Flow at 25-75%
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de junho de 2026
Conclusão Primária (Estimado)
1 de setembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
20 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de agosto de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KOSTU-26-USG
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .