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

21 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

10

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
Diagnostische toets: 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.
Diagnostische toets: 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.
Diagnostische toets: 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.
Apparaat: 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.
Apparaat: 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.
Apparaat: 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.
Diagnostische toets: 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.
Diagnostische toets: 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.
Diagnostische toets: 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.
Apparaat: 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.
Apparaat: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diaphragm Thickening Ratio
Tijdsspanne: Baseline
Diaphragm thickening ratio measured using ultrasonography.
Baseline
Sternocleidomastoid Muscle Thickness
Tijdsspanne: Baseline
Sternocleidomastoid muscle thickness measured using ultrasonography.
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anterior Scalene Muscle Thickness
Tijdsspanne: Baseline
Anterior scalene muscle thickness measured using ultrasonography.
Baseline
Upper Trapezius Muscle Thickness
Tijdsspanne: Baseline
Upper trapezius muscle thickness measured using ultrasonography.
Baseline
Maximal Inspiratory Pressure (MIP)
Tijdsspanne: 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)
Tijdsspanne: Baseline
Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.
Baseline
Maximal Expiratory Pressure (MEP)
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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%
Tijdsspanne: Baseline
Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.
Baseline

Medewerkers en onderzoekers

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Sponsor

Kocaeli Sağlık ve Teknoloji Üniversitesi

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juni 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

20 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KOSTU-26-USG

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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