Neck Pain ChronicISU BT 1NCT07124455
Respiratory Muscle Strength, Endurance, and Postural Control in Chronic Neck Pain With Disability
An observational study of Neck Pain Chronic and Respiratory Function, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain Chronic, Respiratory Function
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2024to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people with chronic non-specific neck pain
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Inflammatory and rheumatological diseases
- Presence of infection in the bone or soft tissue of the cervical spine
- Presence of malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University
Istanbul, Zeytinburnu, 34000
About this study
Official title: Investigation of Respiratory Muscle Strength, Endurance, and Postural Control in Individuals With Non-Specific Chronic Neck Pain and Varying Degrees of Disability
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.
Read the detailed description
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
- Conditions
- Neck Pain Chronic, Respiratory Function
- Keywords
- neck pain, respiratory function, neck disability, respiratory muscle strength, pain
- Medical subject headings
- Respiratory Aspiration, Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Anthropometric Measurements:
Waist circumference and chest circumference measurements at three different regions will be taken.
Measured: 4 weeks
Postural Analysis:
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).
Measured: 4 weeks
Visual Analog Scale:
Perceived exertion, fatigue, and breathlessness will be assessed using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (very severe).
Measured: 4 weeks
Assessment of Postural Control:
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.
Measured: 4 weeks
Borg Scale:
Perceived exertion, fatigue, and breathlessness will be assessed using modified Borg scale, ranging from 0 (none) to 10 (very severe).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start4 Apr 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain ChronicStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Beyza Tanrıöğen, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124455
- Sponsor's protocol ID
- IstinyeU BT 1
- Acronym
- ISU BT 1
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Muscle Strength, Endurance, and Postural Control in Individuals With Non-Specific Chronic Neck Pain and Varying Degrees of Disability
- ClinicalTrials.gov ID
- NCT07124455
- Acronym / sponsor ID
- ISU BT 1 / IstinyeU BT 1
- Conditions
- Neck Pain Chronic, Respiratory Function
- Keywords
- neck pain, respiratory function, neck disability, respiratory muscle strength, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people with chronic non-specific neck pain
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
respiratory function test
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.
Maximum Inspiratory Pressure
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.
Assessment of Cervical Disability:
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).
Measurement of Respiratory Muscle Endurance
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.
Maximum Expiratory Pressure
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.
5 secondary outcomes
Anthropometric Measurements:
Time frame: 4 weeks
Postural Analysis:
Time frame: 4 weeks
Visual Analog Scale:
Time frame: 4 weeks
Assessment of Postural Control:
Time frame: 4 weeks
Borg Scale:
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain Chronic and Respiratory Function, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory function test (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.