NCT07124455

Brief Summary

Neck pain is a common cause of disability worldwide, especially among middle-aged women in wealthy countries. It often occurs in episodes and can become chronic, affecting physical, psychological, emotional, and social aspects of life, which reduces quality of life for both patients and their families. Research has shown that neck pain is linked to problems with movement control, such as reduced neck mobility, increased activity in surface muscles, and poor body position awareness. These issues may lead to breathing problems because surface neck muscles are involved in inhalation. Studies have found that people with chronic neck pain have reduced lung function and altered breathing patterns compared to healthy individuals. However, no research has yet explored how respiratory endurance and balance control relate to neck pain severity. This study will assess respiratory muscle strength, endurance, and postural control in people with chronic neck pain. Participants will be divided into groups based on the severity of their neck disability, and their respiratory and balance measurements will be compared to healthy individuals. The goal is to understand whether worsening neck disability is associated with greater respiratory problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 9, 2025

Last Update Submit

August 9, 2025

Conditions

Keywords

neck painrespiratory functionneck disabilityrespiratory muscle strengthpain

Outcome Measures

Primary Outcomes (5)

  • respiratory function test

    Lung function will be measured with a portable spirometer. The test will record forced vital capacity, the amount of air exhaled in one second, their ratio, and peak flow. Results will be given in liters and compared to predicted normal values. The test follows official guidelines and uses sterilized, personal mouthpieces to ensure safety.

    4 weeks

  • Maximum Inspiratory Pressure

    Maximum inspiratory mouth pressure is the intraoral pressure measured during maximum inspiration against a closed airway valve. For the measurement, the participant is asked to perform a maximum expiration first. Then, the airway valve is closed, and the participant performs a maximum inspiration, maintaining it for 1-3 seconds. The best value out of three attempts will be selected and recorded in cmH₂O. Results will be expressed as a percentage of normal reference values calculated according to age and gender.

    4 weeks

  • Assessment of Cervical Disability:

    Cervical disability will be evaluated using the Turkish version of the Neck Disability Questionnaire. This is one of the most commonly used questionnaires for neck pain. It is used to assess the patient's current condition and progress during treatment. The questionnaire consists of 10 sections completed by the patient, covering pain, personal care, lifting heavy objects, reading, headaches, concentration, work, driving, sleeping, and recreation. Each section is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). An increase in the score indicates greater disability, while a decrease indicates improvement. Based on the total score, disability is classified as follows: 0-4 points (0-8%) no disability, 5-14 points (10-28%) mild disability, 15-24 points (30-48%) moderate disability, 25-34 points (50-64%) severe disability, and 35-40 points (70-100%) complete disability (Vernon et al., 1991; Telci et al., 2009).

    4 weeks

  • Measurement of Respiratory Muscle Endurance

    Respiratory muscle endurance refers to the ability of the respiratory muscles to sustain performance during prolonged or repetitive contractions. This parameter is typically assessed with specific endurance tests and may vary depending on the measurement protocol. During the endurance test, the participant sustains respiratory muscle activity under a given load or intensity for a specified duration, and performance values are recorded.

    4 weeks

  • Maximum Expiratory Pressure

    Maximum Expiratory Pressure is the intraoral pressure measured during maximum expiration against a closed airway valve. For the measurement, the participant first performs a maximum inspiration. Then, the airway valve is closed, and the participant performs maximum expiration, maintaining it for 1-3 seconds. The highest value out of three attempts will be selected and recorded in cmH₂O. Results will be expressed as a percentage of normal reference values calculated according to age and gender.

    4 weeks

Secondary Outcomes (5)

  • Anthropometric Measurements:

    4 weeks

  • Postural Analysis:

    4 weeks

  • Visual Analog Scale:

    4 weeks

  • Assessment of Postural Control:

    4 weeks

  • Borg Scale:

    4 weeks

Study Arms (4)

healthy individuals

participants without neck pain

mild

participant with mild neck disability according to neck disavility index

moderate

participant with moderate neck disability according to neck disavility index

severe

participant with severe neck disability according to neck disavility index

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people with chronic non-specific neck pain

You may qualify if:

  • Individuals diagnosed with Non-Specific Neck Pain by a physician
  • Having complaints of Non-Specific Neck Pain for at least 3 months
  • Aged between 18 and 65 years
  • Willingness to participate voluntarily
  • No diagnosed respiratory disease
  • No diagnosed cardiac disease
  • No diagnosed neuromuscular disease
  • Non-smoker

You may not qualify if:

  • Presence of radiculopathy or structural abnormalities in the cervical region
  • History of surgery on the cervical region
  • Upper respiratory tract infection within the last 3 months
  • History of surgery involving the chest cage or spine
  • Spinal deformities such as scoliosis or kyphosis
  • History of abdominal surgery
  • Inflammatory and rheumatological diseases
  • Presence of infection in the bone or soft tissue of the cervical spine
  • Presence of malignancy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Zeytinburnu, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory AspirationNeck PainPain

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant (PhD student)

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 15, 2025

Study Start

April 4, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations