NCT07021586

Brief 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. 1.Do middle-aged and elderly individuals with chronic cervical pain exhibit reduced maximal tongue pressure compared to those without cervical pain?
  2. 2.What are the effects of different cranio-cervical positioning on tongue pressure performance?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 15, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

May 21, 2025

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    It usually take 5-10 minutes to finish the questionnaire

  • Repetitive Saliva Swallowing Test

    It usually take 30 seconds to collect the data.

  • Temporomandibular joint kinematics

    Because it is a cross sectional study with one-time measurement, it usually take twenty minutes to collect the data.

  • Craniovertebral angle

    Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.

  • Maximal handgrip strength

    It usually take five minutes to collect the data.

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community and regional clinics in Taipei or New Taipei

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Neck PainDeglutition Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Yi-Fen Shih

    National Yang Ming Chiao Tung University

    STUDY CHAIR

Central Study Contacts

Yi-Fen Shih, Professor

CONTACT

Chia Hung Lu, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy and Assistive Technology, National Yang Ming Chaio Tung University

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 15, 2025

Study Start

February 20, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

June 15, 2025

Record last verified: 2024-11

Locations