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

2026년 8월 21일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

10

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Chronic Non-Specific Neck Pain
Participants aged 18-65 years with chronic non-specific neck pain lasting at least 3 months.
진단 검사: 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.
진단 검사: 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.
진단 검사: 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.
장치: 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.
장치: 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.
장치: 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.
진단 검사: 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.
진단 검사: 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.
진단 검사: 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.
장치: 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.
장치: 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.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Diaphragm Thickening Ratio
기간: Baseline
Diaphragm thickening ratio measured using ultrasonography.
Baseline
Sternocleidomastoid Muscle Thickness
기간: Baseline
Sternocleidomastoid muscle thickness measured using ultrasonography.
Baseline

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kocaeli Sağlık ve Teknoloji Üniversitesi

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 10일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 20일

QC 기준을 충족하는 최초 제출

2026년 8월 21일

처음 게시됨 (실제)

2026년 8월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KOSTU-26-USG

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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