Istinye University
Istanbul, Zeytinburnu, 34000, Turkey (Türkiye)
NCT Number: NCT07124455
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.
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Notify Me18 year–65 year
All sexes
Observational
Istanbul, Zeytinburnu, 34000, Turkey (Türkiye)
This study designed as cross-sectional study. Aim
The aim of this study is to investigate the presence of respiratory dysfunction in individuals with chronic non-specific neck pain by evaluating respiratory muscle strength, endurance, and postural control. It also aims to classify the data obtained according to the severity of neck disability and to determine whether respiratory dysfunction is associated with the severity of neck involvement.
Research Hypotheses
H0: There is no difference in respiratory muscle strength, endurance, and postural control parameters between individuals with chronic non-specific neck pain and asymptomatic individuals.
H1: There is a difference in respiratory muscle strength, endurance, and postural control parameters between individuals with chronic non-specific neck pain and asymptomatic individuals.
H2: The severity of chronic non-specific neck pain has no effect on the degree of respiratory impairment.
H3: The severity of chronic non-specific neck pain has an effect on the degree of respiratory impairment.
Specific Objectives of the Study
To assess the severity of neck pain using the Neck Disability Index
To measure the respiratory muscle strength of participants
To measure the respiratory muscle endurance of participants
To evaluate the postural control of participants
To compare respiratory muscle strength, endurance, and postural control between individuals with neck pain and asymptomatic participants
To examine the relationship between the severity of neck pain and the extent of respiratory dysfunction
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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).
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Waist circumference and chest circumference measurements at three different regions will be taken.
Time frame: 4 weeks
For postural analysis, the form developed by Corbin et al. will be used. Scoring will be performed according to the severity of postural deviations observed from the lateral and posterior views (Corbin et al., 2006).
Time frame: 4 weeks
Perceived exertion, fatigue, and breathlessness will be assessed using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (very severe).
Time frame: 4 weeks
The Functional Reach Test will assess postural control using a tape fixed to a wall. Participants stand close to the wall and reach forward with their dominant arm without stepping or lifting heels. Three trials will be done, averaging the last two. Before testing, handedness will be determined. Modified tests include reaching with both arms and on soft surfaces, as well as reaching sideways.
Time frame: 4 weeks
Perceived exertion, fatigue, and breathlessness will be assessed using modified Borg scale, ranging from 0 (none) to 10 (very severe).
Istinye University
Other
Investigation of Respiratory Muscle Strength, Endurance, and Postural Control in Individuals With Non-Specific Chronic Neck Pain and Varying Degrees of Disability
Acronym: ISU BT 1
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