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

21 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

10

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
Test diagnostico: 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.
Test diagnostico: 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.
Test diagnostico: 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.
Dispositivo: 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.
Dispositivo: 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.
Dispositivo: 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.
Test diagnostico: 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.
Test diagnostico: 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.
Test diagnostico: 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.
Dispositivo: 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.
Dispositivo: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diaphragm Thickening Ratio
Lasso di tempo: Baseline
Diaphragm thickening ratio measured using ultrasonography.
Baseline
Sternocleidomastoid Muscle Thickness
Lasso di tempo: Baseline
Sternocleidomastoid muscle thickness measured using ultrasonography.
Baseline

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kocaeli Sağlık ve Teknoloji Üniversitesi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 giugno 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

20 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2026

Primo Inserito (Effettivo)

24 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KOSTU-26-USG

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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