An observational study in Chronic Neck Pain and Healthy (Controls), sponsored by Kocaeli Sağlık ve Teknoloji Üniversitesi. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Kocaeli Sağlık ve Teknoloji Üniversitesi · Observational
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.
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.
Kocaeli Sağlık ve Teknoloji Üniversitesi is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Chronic Non-Specific Neck Pain Group:
Healthy Control Group:
Exclusion Criteria (Both Groups):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
Diagnostic Test: Diaphragm Ultrasonography · Diagnostic Test: Anterior Scalene Muscle Ultrasonography · Diagnostic Test: Upper Trapezius Muscle Ultrasonography · Device: Maximal Inspiratory Pressure Measurement · Device: Maximal Expiratory Pressure Measurement · Device: Pulmonary Function Testing
Age-matched healthy individuals without neck pain during the previous 3 months.
Diagnostic Test: Diaphragm Ultrasonography · Diagnostic Test: Anterior Scalene Muscle Ultrasonography · Diagnostic Test: Upper Trapezius Muscle Ultrasonography · Device: Maximal Inspiratory Pressure Measurement · Device: Maximal Expiratory Pressure Measurement · Device: Pulmonary Function Testing
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.
Diaphragm Thickening Ratio
Diaphragm thickening ratio measured using ultrasonography.
Time frame: Baseline
Sternocleidomastoid Muscle Thickness
Sternocleidomastoid muscle thickness measured using ultrasonography.
Time frame: Baseline
Anterior Scalene Muscle Thickness
Anterior scalene muscle thickness measured using ultrasonography.
Time frame: Baseline
Upper Trapezius Muscle Thickness
Upper trapezius muscle thickness measured using ultrasonography.
Time frame: Baseline
Maximal Inspiratory Pressure (MIP)
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.
Time frame: Baseline
Forced Vital Capacity (L)
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Time frame: Baseline
Maximal Expiratory Pressure (MEP)
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.
Time frame: Baseline
Forced Expiratory Volume in 1 Second (L)
Forced expiratory volume in the first second will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Time frame: Baseline
FEV1/FVC Ratio (%)
The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.
Time frame: Baseline
Peak Expiratory Flow (L/sn)
Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Time frame: Baseline
Forced Expiratory Flow at 25-75%
Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
Time frame: Baseline
Plan to share: No — 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.
Started Jun 2026 (actual). Primary completion is estimated for Sep 2026, 2 months after the start.
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