Cervical Pain, PosteriorNCT07021586
Tongue Pressure in Middle-Aged and Elderly Individuals With Chronic Cervical Pain
An observational study of Cervical Pain, Posterior and Swallowing Difficulties, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The goal of the cross-sectional study is to explore the impact of neck pain on tongue pressure in the middle-aged and elderly population and analyze the effects of different cranio-cervical positioning on tongue pressure performance. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain, Posterior, Swallowing Difficulties, Swallowing Disorders
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community and regional clinics in Taipei or New Taipei
- Inclusion Criteria (chronic cervical pain group):
- Aged between 50-65 year olds
- Chronic neck pain (caused by specific neck movements or prolonged neck posture)
- Cervical pain duration: at least 3 months within the past year
- Cervical pain intensity: during activity or rest, as measured by the Numeric Pain Rating Scale, must have an average score of at least 3 over the past two weeks
- No anti-inflammatory or painkillers can be used within 48 hours prior to the test
- Inclusion Criteria (healthy group):
- Matching gender, age, and body mass index with those in the chronic cervical pain group
- No cervical pain has occurred within the past 6 months
- Exclusion Criteria:
- Neurological diseases that may affect tongue pressure readings, such as stroke or Parkinson's disease
- Head or neck surgery in the past year
- Severe head or neck injuries (e.g., whiplash from a car accident) in the past year
- Diagnosed with cervical radiculopathy or myelopathy with symptoms in the form of numbness or tingling, or fail relative clinical tests (spurling's/ cervical distraction/ cervical rotation test/ upper limb tension test-1/ Hoffman sign)
- History of head or neck deformities or cancer
- History of head or neck radiation therapy
- Diagnosed with dysphagia
- Experience pain or restricted movement in the temporomandibular joint (TMJ) during chewing in the last 6 months
- Require anticonvulsants or antidepressant medications
- Cognitive impairments preventing understanding of the test order or communication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei
National Yang Ming Chiao Tung University Orthopaedic laboratory, 0228267340, yfshih@nycu.edu.tw
About this study
The goal of the cross-sectional study is to explore the impact of neck pain on tongue pressure in the middle-aged and elderly population and analyze the effects of different cranio-cervical positioning on tongue pressure performance.
The main questions it aims to answer are:
- Do middle-aged and elderly individuals with chronic cervical pain exhibit reduced maximal tongue pressure compared to those without cervical pain?
- What are the effects of different cranio-cervical positioning on tongue pressure performance?
Participants will complete all the assessments on the day of testing.
Read the detailed description
- For Quality assurance plan that addresses data validation and registry procedures: (1) Relevant data will be recorded by the researchers. All assessments will be conducted in the Orthopedic Laboratory at National Yang Ming Chiao Tung University, where the equipment is regularly maintained and monitored.
- For Standard operating procedures to address registry operations and analysis activities: (1 ) Participants will be recruited from clinics and communities in the Taipei and New Taipei City. Collected data will include personal information such as height, age, weight, and the number of removable dentures. Data management and analysis will be conducted using laboratory-designated computers for data storage and processing. Any adverse events, such as throat or tongue soreness occurring within 1-2 days after testing, will be recorded and reported to the researchers.
- For Sample size assessment: (1) Total forty participants aged between 50-65 years.
- For missing data: (1) This study is a cross-sectional, single-session assessment, and therefore the likelihood of missing data is minimal and no specific handling procedures are needed.
- For statistical analysis: (1) Data analysis for this study was conducted using SPSS software version 29.0. Continuous and categorical variables were compared between the two groups using independent t-tests and chi-square tests. Other outcomes will be analyzed using two-way mixed ANOVA, independent t-tests, or Pearson's correlation coefficient to compare differences between groups or examine associations. The significance level is set at 0.05, with p-values less than 0.05 considered statistically significant.
- Medical subject headings
- Neck Pain, Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tongue pressure
Tongue pressure is used to measure the function or strength of the tongue. The higher the value, the greater the tongue strength. The measurement unit is kPa, with 0 being the minimum value. It tends to decrease with age, typically with 60 years old as the cutoff. For those under 60, the value is around 40 kPa, and for those over 60kPa, it decreases to around 33 kPa. Additionally, when accompanied by other conditions, such as dysphagia or sarcopenia, the decline is more pronounced.
Measured: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.
Secondary outcomes (5)
Mandarin version of Eating Assessment Tool-10
The Eating Assessment Tool is a commonly used self-administered questionnaire for screening potential swallowing difficulties. In this study, the Mandarin version of the EAT-10 is utilized. The questionnaire consists of 10 items, where participants rate the severity of their swallowing-related symptoms based on their subjective perception. Each item is scored from 0 (no problem) to 4 (severe problem), with a total possible score of 40. Higher scores indicate greater severity of perceived swallowing difficulties.
Measured: It usually take 5-10 minutes to finish the questionnaire
Repetitive Saliva Swallowing Test
Repetitive Saliva Swallowing Test is a simple and relatively safe test used to screen for potential functional swallowing difficulties. During the test, the participant first moistens their mouth with water. The examiner places their index finger under the participant's tongue and their middle finger on the participant's laryngeal prominence. The test instruction is, 'Please swallow saliva as much as possible until I say stop.' The examiner palpates the participant's laryngeal prominence to feel the movements during swallowing and counts the number of swallows. The test duration is 30 seconds. If the participant swallows less than three times within 30 seconds, it is used as the screening criterion for potential functional swallowing difficulty.
Measured: It usually take 30 seconds to collect the data.
Temporomandibular joint kinematics
Temporomandibular joint kinematics is used to measure the kinematics of the temporomandibular joint. The parameters include maximal mouth opening, left/right mandibular deviation, protrusion, left/right total condylar length path, and left/right total condylar translation, with measurements in millimeters (mm). Left/right total condylar rotation is measured in degrees. A larger value for the above parameters indicates greater temporomandibular joint mobility.
Measured: Because it is a cross sectional study with one-time measurement, it usually take twenty minutes to collect the data.
Craniovertebral angle
The craniovertebral angle is defined as the acute angle formed by the intersection between two lines: one is the horizontal line passing through the spinous process of the seventh cervical vertebra, and the other is the line connecting the seventh cervical vertebra and the tragus of the ear. If this angle is less than 50 degrees, it is defined as exhibiting a forward head posture. The smaller the angle, the more severe the forward head posture.
Measured: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.
Maximal handgrip strength
This study uses a digital hand dynamometer to measure maximal grip strength. A higher value indicates greater handgrip strength. When the handgrip strength is less than 28 kg for males or less than 18 kg for females, it suggests a potential tendency for sarcopenia.
Measured: It usually take five minutes to collect the data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start20 Feb 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Pain, PosteriorStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021586
- Sponsor's protocol ID
- NYCU113186AE
- Status last verified
- Nov 2024
- First submitted
- 21 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Pressure in Middle-Aged and Elderly Individuals With Chronic Cervical Pain
- ClinicalTrials.gov ID
- NCT07021586
- Acronym / sponsor ID
- NYCU113186AE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Jun 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.
The goal of the cross-sectional study is to explore the impact of neck pain on tongue pressure in the middle-aged and elderly population and analyze the effects of different cranio-cervical positioning on tongue pressure performance.
The main questions it aims to answer are:
- Do middle-aged and elderly individuals with chronic cervical pain exhibit reduced maximal tongue pressure compared to those without cervical pain?
- What are the effects of different cranio-cervical positioning on tongue pressure performance?
Participants will complete all the assessments on the day of testing.
Detailed description
- For Quality assurance plan that addresses data validation and registry procedures: (1) Relevant data will be recorded by the researchers. All assessments will be conducted in the Orthopedic Laboratory at National Yang Ming Chiao Tung University, where the equipment is regularly maintained and monitored.
- For Standard operating procedures to address registry operations and analysis activities: (1 ) Participants will be recruited from clinics and communities in the Taipei and New Taipei City. Collected data will include personal information such as height, age, weight, and the number of removable dentures. Data management and analysis will be conducted using laboratory-designated computers for data storage and processing. Any adverse events, such as throat or tongue soreness occurring within 1-2 days after testing, will be recorded and reported to the researchers.
- For Sample size assessment: (1) Total forty participants aged between 50-65 years.
- For missing data: (1) This study is a cross-sectional, single-session assessment, and therefore the likelihood of missing data is minimal and no specific handling procedures are needed.
- For statistical analysis: (1) Data analysis for this study was conducted using SPSS software version 29.0. Continuous and categorical variables were compared between the two groups using independent t-tests and chi-square tests. Other outcomes will be analyzed using two-way mixed ANOVA, independent t-tests, or Pearson's correlation coefficient to compare differences between groups or examine associations. The significance level is set at 0.05, with p-values less than 0.05 considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community and regional clinics in Taipei or New Taipei
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
Maximal tongue pressure
Time frame: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.
Tongue pressure is used to measure the function or strength of the tongue. The higher the value, the greater the tongue strength. The measurement unit is kPa, with 0 being the minimum value. It tends to decrease with age, typically with 60 years old as the cutoff. For those under 60, the value is around 40 kPa, and for those over 60kPa, it decreases to around 33 kPa. Additionally, when accompanied by other conditions, such as dysphagia or sarcopenia, the decline is more pronounced.
5 secondary outcomes
Mandarin version of Eating Assessment Tool-10
Time frame: It usually take 5-10 minutes to finish the questionnaire
Repetitive Saliva Swallowing Test
Time frame: It usually take 30 seconds to collect the data.
Temporomandibular joint kinematics
Time frame: Because it is a cross sectional study with one-time measurement, it usually take twenty minutes to collect the data.
Craniovertebral angle
Time frame: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.
Maximal handgrip strength
Time frame: It usually take five minutes to collect the data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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.
Yi-Fen Shih study chair
National Yang Ming Chiao Tung University
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 Cervical Pain, Posterior and Swallowing Difficulties, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Fen Shih, Professor (+886-0228267340, yfshih@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal tongue pressure (time frame: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.). 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 Jun 2025.