Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)
2026年8月21日 更新者：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.
研究概览
地位
招聘中
详细说明
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.
研究类型
观察性的
注册 (估计的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hatice Sena Çınarlı, assisstant professor
- 电话号码：05436093619
- 邮箱：haticesena.cinarli@kocaelisaglik.edu.tr
学习地点
-
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Derince
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Kocaeli、Derince、土耳其（türkiye）、41000
- 招聘中
- Derince Training and Research Hospital
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接触：
- İlhan Celil Çınarlı, MD
- 电话号码：05436093619
- 邮箱：haticesena.cinarli@kocaelisaglik.edu.tr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
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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.
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Healthy Control
Age-matched healthy individuals without neck pain during the previous 3 months.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diaphragm Thickening Ratio
大体时间：Baseline
|
Diaphragm thickening ratio measured using ultrasonography.
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Baseline
|
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Sternocleidomastoid Muscle Thickness
大体时间：Baseline
|
Sternocleidomastoid muscle thickness measured using ultrasonography.
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anterior Scalene Muscle Thickness
大体时间：Baseline
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Anterior scalene muscle thickness measured using ultrasonography.
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Baseline
|
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Upper Trapezius Muscle Thickness
大体时间：Baseline
|
Upper trapezius muscle thickness measured using ultrasonography.
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Baseline
|
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Maximal Inspiratory Pressure (MIP)
大体时间：Baseline
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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.
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Baseline
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Forced Vital Capacity (L)
大体时间：Baseline
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Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
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Baseline
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Maximal Expiratory Pressure (MEP)
大体时间：Baseline
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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.
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Baseline
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Forced Expiratory Volume in 1 Second (L)
大体时间：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 (%)
大体时间：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)
大体时间：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%
大体时间：Baseline
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Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月10日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月20日
首先提交符合 QC 标准的
2026年8月21日
首次发布 (实际的)
2026年8月24日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- KOSTU-26-USG
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.