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NCT Number: NCT07782099

Accessory Inspiratory Muscles in Chronic Neck Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Derince Training and Research Hospital

Kocaeli, Derince, 41000, Turkey (Türkiye)

Location status: Recruiting

Location contact

İlhan Celil Çınarlı, MD

CONTACT

[email protected]

05436093619

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diaphragm ultrasonography

Diagnostic 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 Ultrasonography

Diagnostic 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 Ultrasonography

Diagnostic 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 Measurement

Device

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 Measurement

Device

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

Device

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.

Primary outcomes

  1. Diaphragm Thickening Ratio

    Time frame: Baseline

    Diaphragm thickening ratio measured using ultrasonography.

  2. Sternocleidomastoid Muscle Thickness

    Time frame: Baseline

    Sternocleidomastoid muscle thickness measured using ultrasonography.

Secondary outcomes

  1. Anterior Scalene Muscle Thickness

    Time frame: Baseline

    Anterior scalene muscle thickness measured using ultrasonography.

  2. Upper Trapezius Muscle Thickness

    Time frame: Baseline

    Upper trapezius muscle thickness measured using ultrasonography.

  3. Maximal Inspiratory Pressure (MIP)

    Time frame: 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.

  4. Forced Vital Capacity (L)

    Time frame: Baseline

    Forced vital capacity will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.

  5. Maximal Expiratory Pressure (MEP)

    Time frame: 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.

  6. Forced Expiratory Volume in 1 Second (L)

    Time frame: Baseline

    Forced expiratory volume in the first second will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.

  7. FEV1/FVC Ratio (%)

    Time frame: Baseline

    The ratio of forced expiratory volume in the first second to forced vital capacity will be determined from spirometry measurements.

  8. Peak Expiratory Flow (L/sn)

    Time frame: Baseline

    Peak expiratory flow will be measured using spirometry during a maximal forced expiratory maneuver performed after maximal inspiration.

  9. Forced Expiratory Flow at 25-75%

    Time frame: Baseline

    Forced expiratory flow during the middle 50% of the forced vital capacity maneuver will be measured using spirometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Sena Çınarlı, assisstant professor

CONTACT

[email protected]

05436093619

Sponsors and collaborators

Lead sponsor

Kocaeli Sağlık ve Teknoloji Üniversitesi

Other

Registry information

Official study 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

Acronym: AIM-CNP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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