Chronic Neck PainAIM-CNPNCT07782099
Accessory Inspiratory Muscles in Chronic Neck Pain
An observational study of Chronic Neck Pain and Healthy (Controls), run by Kocaeli Sağlık ve Teknoloji Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain, Healthy (Controls)
- What is being tested?
- Diaphragm Ultrasonography, Anterior Scalene Muscle Ultrasonography and Upper Trapezius Muscle Ultrasonography
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 1 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Derince Training and Research Hospital
Kocaeli, Derince, 41000
İlhan Celil Çınarlı, MD, 05436093619, haticesena.cinarli@kocaelisaglik.edu.tr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Neck Pain, Healthy (Controls)
- Being tested
- Diaphragm Ultrasonography, Anterior Scalene Muscle Ultrasonography, Upper Trapezius Muscle Ultrasonography, Maximal Inspiratory Pressure Measurement, Maximal Expiratory Pressure Measurement
- Keywords
- Chronic Non-Specific Neck Pain, Accessory Inspiratory Muscles, Respiratory Function, Ultrasonography
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm UltrasonographyDiagnostic test
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 UltrasonographyDiagnostic test
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 UltrasonographyDiagnostic test
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 MeasurementDevice
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 MeasurementDevice
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 TestingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Non-Specific Neck Pain | Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months. Receives: 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 | |
| Healthy Control | Age-matched healthy individuals without neck pain during the previous 3 months. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickening Ratio
Diaphragm thickening ratio measured using ultrasonography.
Measured: Baseline
Sternocleidomastoid Muscle Thickness
Sternocleidomastoid muscle thickness measured using ultrasonography.
Measured: Baseline
Secondary outcomes (9)
Anterior Scalene Muscle Thickness
Anterior scalene muscle thickness measured using ultrasonography.
Measured: Baseline
Upper Trapezius Muscle Thickness
Upper trapezius muscle thickness measured using ultrasonography.
Measured: 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.
Measured: Baseline
Forced Vital Capacity (L)
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Measured: 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.
Measured: 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.
Measured: Baseline
FEV1/FVC Ratio (%)
The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.
Measured: Baseline
Peak Expiratory Flow (L/sn)
Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start10 Jun 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Çınarlı, Kocaeli Sağlık ve Teknoloji Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782099
- Sponsor's protocol ID
- KOSTU-26-USG
- Acronym
- AIM-CNP
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 38109804Hii 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.
PubMed 38615408
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07782099
- Acronym / sponsor ID
- AIM-CNP / KOSTU-26-USG
- Conditions
- Chronic Neck Pain, Healthy (Controls)
- Keywords
- Chronic Non-Specific Neck Pain, Accessory Inspiratory Muscles, Respiratory Function, Ultrasonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji ÜniversitesiUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Non-Specific Neck Pain | – | 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 TestingParticipants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months. |
| Healthy Control | – | 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 TestingAge-matched healthy individuals without neck pain during the previous 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm UltrasonographyDiaphragm 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. | Diagnostic test | Chronic Non-Specific Neck Pain, Healthy Control |
| Anterior Scalene Muscle UltrasonographyAnterior 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. | Diagnostic test | Chronic Non-Specific Neck Pain, Healthy Control |
| Upper Trapezius Muscle UltrasonographyUpper 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. | Diagnostic test | Chronic Non-Specific Neck Pain, Healthy Control |
| Maximal Inspiratory Pressure MeasurementMaximal 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. | Device | Chronic Non-Specific Neck Pain, Healthy Control |
| Maximal Expiratory Pressure MeasurementMaximal 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. | Device | Chronic Non-Specific Neck Pain, Healthy Control |
| Pulmonary Function TestingPulmonary 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. | Device | Chronic Non-Specific Neck Pain, Healthy Control |
Primary outcome
Diaphragm Thickening Ratio
Time frame: Baseline
Diaphragm thickening ratio measured using ultrasonography.
Sternocleidomastoid Muscle Thickness
Time frame: Baseline
Sternocleidomastoid muscle thickness measured using ultrasonography.
9 secondary outcomes
Anterior Scalene Muscle Thickness
Time frame: Baseline
Upper Trapezius Muscle Thickness
Time frame: Baseline
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline
Forced Vital Capacity (L)
Time frame: Baseline
Maximal Expiratory Pressure (MEP)
Time frame: Baseline
Forced Expiratory Volume in 1 Second (L)
Time frame: Baseline
FEV1/FVC Ratio (%)
Time frame: Baseline
Peak Expiratory Flow (L/sn)
Time frame: Baseline
Forced Expiratory Flow at 25-75%
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 38109804Colak 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.
- Background: PubMed 38615408Hii 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain and Healthy (Controls), run by Kocaeli Sağlık ve Teknoloji Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Sena Çınarlı, assisstant professor (05436093619, haticesena.cinarli@kocaelisaglik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickening Ratio (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.