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Accessory Inspiratory Muscles in Chronic Neck Pain (AIM-CNP)

21. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

10

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
Diagnostisk test: Diaphragm Ultrasonography
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.
Diagnostisk test: Anterior Scalene Muscle Ultrasonography
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.
Diagnostisk test: Upper Trapezius Muscle Ultrasonography
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.
Enhed: Maximal Inspiratory Pressure Measurement
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.
Enhed: Maximal Expiratory Pressure Measurement
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.
Enhed: Pulmonary Function Testing
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.
Diagnostisk test: Diaphragm Ultrasonography
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.
Diagnostisk test: Anterior Scalene Muscle Ultrasonography
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.
Diagnostisk test: Upper Trapezius Muscle Ultrasonography
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.
Enhed: Maximal Inspiratory Pressure Measurement
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.
Enhed: Maximal Expiratory Pressure Measurement
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.
Enhed: Pulmonary Function Testing
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diaphragm Thickening Ratio
Tidsramme: Baseline
Diaphragm thickening ratio measured using ultrasonography.
Baseline
Sternocleidomastoid Muscle Thickness
Tidsramme: Baseline
Sternocleidomastoid muscle thickness measured using ultrasonography.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anterior Scalene Muscle Thickness
Tidsramme: Baseline
Anterior scalene muscle thickness measured using ultrasonography.
Baseline
Upper Trapezius Muscle Thickness
Tidsramme: Baseline
Upper trapezius muscle thickness measured using ultrasonography.
Baseline
Maximal Inspiratory Pressure (MIP)
Tidsramme: 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)
Tidsramme: Baseline
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Baseline
Maximal Expiratory Pressure (MEP)
Tidsramme: 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)
Tidsramme: Baseline
Forced expiratory volume in the first second will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Baseline
FEV1/FVC Ratio (%)
Tidsramme: Baseline
The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.
Baseline
Peak Expiratory Flow (L/sn)
Tidsramme: Baseline
Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Baseline
Forced Expiratory Flow at 25-75%
Tidsramme: Baseline
Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kocaeli Sağlık ve Teknoloji Üniversitesi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

20. juni 2026

Først indsendt, der opfyldte QC-kriterier

21. august 2026

Først opslået (Faktiske)

24. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KOSTU-26-USG

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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