Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)
21. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
10
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hatice Sena Çınarlı, assisstant professor
- Telefonnummer: 05436093619
- E-post: haticesena.cinarli@kocaelisaglik.edu.tr
Studiesteder
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Derince
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Kocaeli, Derince, Tyrkia (Türkiye), 41000
- Rekruttering
- Derince Training and Research Hospital
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Ta kontakt med:
- İlhan Celil Çınarlı, MD
- Telefonnummer: 05436093619
- E-post: haticesena.cinarli@kocaelisaglik.edu.tr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diaphragm Thickening Ratio
Tidsramme: Baseline
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Diaphragm thickening ratio measured using ultrasonography.
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Baseline
|
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Sternocleidomastoid Muscle Thickness
Tidsramme: Baseline
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Sternocleidomastoid muscle thickness measured using ultrasonography.
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Baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Anterior Scalene Muscle Thickness
Tidsramme: 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
Tidsramme: Baseline
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Upper trapezius muscle thickness measured using ultrasonography.
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Baseline
|
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Maximal Inspiratory Pressure (MIP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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%
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. juni 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
20. juni 2026
Først innsendt som oppfylte QC-kriteriene
21. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KOSTU-26-USG
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .